Trial Outcomes & Findings for Cannabis for Spasticity in Multiple Sclerosis (NCT NCT00682929)

NCT ID: NCT00682929

Last Updated: 2018-05-18

Results Overview

A modified servo-controlled torque motor system (Lido WorkSet II) was designed for this study to analyze the resistance to passive movement of the knee. It determines the amount of torque required to move the knee joint (without voluntary resistance) at high velocities (up to 200 degrees per second) and at slow velocities (as low as 10 degrees per second). The slow displacement torque is a measure of the passive resistance to movement (from the connective tissue and the non-contracting muscle) and the rapid displacement torques are the sum of the passive and active (involuntary) resistance. The active (involuntary) resistance is the result of the stretch reflex and correlates well with the clinical assessment of spasticity. The change was calculated by taking the value at Week 3 and subtracting the value at Week 0. A negative result indicates a decrease in the torque measured and correlates to a decrease in spasticity and a better outcome.

• Recruitment status: TERMINATED
• Study phase: PHASE1/PHASE2
• Target enrollment: 41 participants
• Primary outcome timeframe: Week 0, Week 3
• Results posted on: 2018-05-18

Participant Flow

Recruitment period began in April 2004 and continued through 2016. Subjects were recruited from the UC Davis Neurology Clinic and through self-referrals.

Participant milestones

Measure	1) Inhaled Cannabis Inhaled cannabis is compared to oral placebo. Inhaled Cannabis: 20 people will be enrolled in this arm of the study and will receive study drug for 7 weeks. Subjects in this arm of the study will be instructed to take their oral medication (placebo for this group) two and a half hours prior to the inhaled medication. Subjects will take two pills and smoke one cannabis cigarette, daily.	2) Oral THC Inhaled placebo is compared to oral THC. Oral THC: 20 people will be enrolled in this arm of the study and will receive study drug for 7 weeks. Subjects in this arm of the study will be instructed to take their oral medication (two 5mg dronabinol tablets) two and a half hours prior to the inhaled medication (placebo for this group). Subjects will take two pills and smoke one cigarette, daily.	3) Placebo Inhaled placebo is compared to oral placebo. Placebo: 20 people will be enrolled in this arm of the study and will receive study drug for 7 weeks. Subjects in this arm of the study will be instructed to take their oral medication (placebo) two and a half hours prior to the inhaled medication (placebo). Subjects will take two pills and smoke one cigarette, daily.
Overall Study STARTED	13	14	14
Overall Study COMPLETED	7	9	12
Overall Study NOT COMPLETED	6	5	2

Reasons for withdrawal

Measure	1) Inhaled Cannabis Inhaled cannabis is compared to oral placebo. Inhaled Cannabis: 20 people will be enrolled in this arm of the study and will receive study drug for 7 weeks. Subjects in this arm of the study will be instructed to take their oral medication (placebo for this group) two and a half hours prior to the inhaled medication. Subjects will take two pills and smoke one cannabis cigarette, daily.	2) Oral THC Inhaled placebo is compared to oral THC. Oral THC: 20 people will be enrolled in this arm of the study and will receive study drug for 7 weeks. Subjects in this arm of the study will be instructed to take their oral medication (two 5mg dronabinol tablets) two and a half hours prior to the inhaled medication (placebo for this group). Subjects will take two pills and smoke one cigarette, daily.	3) Placebo Inhaled placebo is compared to oral placebo. Placebo: 20 people will be enrolled in this arm of the study and will receive study drug for 7 weeks. Subjects in this arm of the study will be instructed to take their oral medication (placebo) two and a half hours prior to the inhaled medication (placebo). Subjects will take two pills and smoke one cigarette, daily.
Overall Study Adverse Event	4	1	1
Overall Study Withdrawal by Subject	1	2	1
Overall Study dosing compliance < 80%	0	2	0
Overall Study lag in DEA renewal	1	0	0

Baseline Characteristics

Cannabis for Spasticity in Multiple Sclerosis

Baseline characteristics by cohort

Measure	1) Inhaled Cannabis n=13 Participants Inhaled cannabis is compared to oral placebo. Inhaled Cannabis: 20 people will be enrolled in this arm of the study and will receive study drug for 7 weeks. Subjects in this arm of the study will be instructed to take their oral medication (placebo for this group) two and a half hours prior to the inhaled medication. Subjects will take two pills and smoke one cannabis cigarette, daily.	2) Oral THC n=14 Participants Inhaled placebo is compared to oral THC. Oral THC: 20 people will be enrolled in this arm of the study and will receive study drug for 7 weeks. Subjects in this arm of the study will be instructed to take their oral medication (two 5mg dronabinol tablets) two and a half hours prior to the inhaled medication (placebo for this group). Subjects will take two pills and smoke one cigarette, daily.	3) Placebo n=14 Participants Inhaled placebo is compared to oral placebo. Placebo: 20 people will be enrolled in this arm of the study and will receive study drug for 7 weeks. Subjects in this arm of the study will be instructed to take their oral medication (placebo) two and a half hours prior to the inhaled medication (placebo). Subjects will take two pills and smoke one cigarette, daily.	Total n=41 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Age, Categorical Between 18 and 65 years	13 Participants n=5 Participants	13 Participants n=7 Participants	12 Participants n=5 Participants	38 Participants n=4 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants	3 Participants n=4 Participants
Sex: Female, Male Female	5 Participants n=5 Participants	7 Participants n=7 Participants	8 Participants n=5 Participants	20 Participants n=4 Participants
Sex: Female, Male Male	8 Participants n=5 Participants	7 Participants n=7 Participants	6 Participants n=5 Participants	21 Participants n=4 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	13 Participants n=5 Participants	14 Participants n=7 Participants	14 Participants n=5 Participants	41 Participants n=4 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Black or African American	2 Participants n=5 Participants	2 Participants n=7 Participants	1 Participants n=5 Participants	5 Participants n=4 Participants
Race (NIH/OMB) White	11 Participants n=5 Participants	12 Participants n=7 Participants	13 Participants n=5 Participants	36 Participants n=4 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Region of Enrollment United States	13 Participants n=5 Participants	14 Participants n=7 Participants	14 Participants n=5 Participants	41 Participants n=4 Participants

PRIMARY outcome

Timeframe: Week 0, Week 3

Population: Only 28 subjects completed the study through the Wk 7 visit; 2 subjects who discontinued early (AE and withdraw by subject) were active at the Wk 3 visit and were included in the Wk 3 analysis; only 25 total subjects had Lido assessments at both the Week 0 and Week 3 study visits and were able to be analyzed for this outcome measure.

A modified servo-controlled torque motor system (Lido WorkSet II) was designed for this study to analyze the resistance to passive movement of the knee. It determines the amount of torque required to move the knee joint (without voluntary resistance) at high velocities (up to 200 degrees per second) and at slow velocities (as low as 10 degrees per second). The slow displacement torque is a measure of the passive resistance to movement (from the connective tissue and the non-contracting muscle) and the rapid displacement torques are the sum of the passive and active (involuntary) resistance. The active (involuntary) resistance is the result of the stretch reflex and correlates well with the clinical assessment of spasticity. The change was calculated by taking the value at Week 3 and subtracting the value at Week 0. A negative result indicates a decrease in the torque measured and correlates to a decrease in spasticity and a better outcome.

Outcome measures

Measure	1) Inhaled Cannabis n=7 Participants Inhaled cannabis is compared to oral placebo. Inhaled Cannabis: 20 people will be enrolled in this arm of the study and will receive study drug for 7 weeks. Subjects in this arm of the study will be instructed to take their oral medication (placebo for this group) two and a half hours prior to the inhaled medication. Subjects will take two pills and smoke one cannabis cigarette, daily.	2) Oral THC n=9 Participants Inhaled placebo is compared to oral THC. Oral THC: 20 people will be enrolled in this arm of the study and will receive study drug for 7 weeks. Subjects in this arm of the study will be instructed to take their oral medication (two 5mg dronabinol tablets) two and a half hours prior to the inhaled medication (placebo for this group). Subjects will take two pills and smoke one cigarette, daily.	3) Placebo n=9 Participants Inhaled placebo is compared to oral placebo. Placebo: 20 people will be enrolled in this arm of the study and will receive study drug for 7 weeks. Subjects in this arm of the study will be instructed to take their oral medication (placebo) two and a half hours prior to the inhaled medication (placebo). Subjects will take two pills and smoke one cigarette, daily.
Change From Week 0 to Week 3 in the Rate of Torque Increase, Flexion	0.0018 degrees/second Standard Deviation 0.0071	-0.0121 degrees/second Standard Deviation 0.0183	0.0007 degrees/second Standard Deviation 0.0064

PRIMARY outcome

Timeframe: Week 0, Week 3

Population: Only 28 subjects completed the study through the Wk 7 visit; 2 subjects who discontinued early (AE and withdraw by subject) were active at the Wk 3 visit and were included in the Wk 3 analysis; only 25 total subjects had Lido assessments at both the Week 0 and Week 3 study visits and were able to be analyzed for this outcome measure.

A modified servo-controlled torque motor system (Lido WorkSet II) was designed for this study to analyze the resistance to passive movement of the knee. It determines the amount of torque required to move the knee joint (without voluntary resistance) at high velocities (up to 200 degrees per second) and at slow velocities (as low as 10 degrees per second). The slow displacement torque is a measure of the passive resistance to movement (from the connective tissue and the non-contracting muscle) and the rapid displacement torques are the sum of the passive and active (involuntary) resistance. The active (involuntary) resistance is the result of the stretch reflex and correlates well with the clinical assessment of spasticity. The change was calculated by taking the value at Week 3 and subtracting the value at Week 0. A negative result indicates a decrease in the torque measured and correlates to a decrease in spasticity and a better outcome.

Outcome measures

Measure	1) Inhaled Cannabis n=7 Participants Inhaled cannabis is compared to oral placebo. Inhaled Cannabis: 20 people will be enrolled in this arm of the study and will receive study drug for 7 weeks. Subjects in this arm of the study will be instructed to take their oral medication (placebo for this group) two and a half hours prior to the inhaled medication. Subjects will take two pills and smoke one cannabis cigarette, daily.	2) Oral THC n=9 Participants Inhaled placebo is compared to oral THC. Oral THC: 20 people will be enrolled in this arm of the study and will receive study drug for 7 weeks. Subjects in this arm of the study will be instructed to take their oral medication (two 5mg dronabinol tablets) two and a half hours prior to the inhaled medication (placebo for this group). Subjects will take two pills and smoke one cigarette, daily.	3) Placebo n=9 Participants Inhaled placebo is compared to oral placebo. Placebo: 20 people will be enrolled in this arm of the study and will receive study drug for 7 weeks. Subjects in this arm of the study will be instructed to take their oral medication (placebo) two and a half hours prior to the inhaled medication (placebo). Subjects will take two pills and smoke one cigarette, daily.
Change From Week 0 to Week 3 in the Rate of Torque Increase, Extension	0.0004 degrees/second Standard Deviation 0.0136	-0.0310 degrees/second Standard Deviation 0.0780	0.0105 degrees/second Standard Deviation 0.0208

PRIMARY outcome

Timeframe: Week 0, Week 7

Population: Only 28 subjects completed the study through the Wk 7 visit; Of these 28 subjects, only 26 subjects had Lido assessments at both the Week 0 and Week 7 study visits and were able to be analyzed for this outcome measure.

A modified servo-controlled torque motor system (Lido WorkSet II) was designed for this study to analyze the resistance to passive movement of the knee. It determines the amount of torque required to move the knee joint (without voluntary resistance) at high velocities (up to 200 degrees per second) and at slow velocities (as low as 10 degrees per second). The slow displacement torque is a measure of the passive resistance to movement (from the connective tissue and the non-contracting muscle) and the rapid displacement torques are the sum of the passive and active (involuntary) resistance. The active (involuntary) resistance is the result of the stretch reflex and correlates well with the clinical assessment of spasticity. The change was calculated by taking the value at Week 7 and subtracting the value at Week 0. A negative result indicates a decrease in the torque measured and correlates to a decrease in spasticity and a better outcome.

Outcome measures

Measure	1) Inhaled Cannabis n=7 Participants Inhaled cannabis is compared to oral placebo. Inhaled Cannabis: 20 people will be enrolled in this arm of the study and will receive study drug for 7 weeks. Subjects in this arm of the study will be instructed to take their oral medication (placebo for this group) two and a half hours prior to the inhaled medication. Subjects will take two pills and smoke one cannabis cigarette, daily.	2) Oral THC n=8 Participants Inhaled placebo is compared to oral THC. Oral THC: 20 people will be enrolled in this arm of the study and will receive study drug for 7 weeks. Subjects in this arm of the study will be instructed to take their oral medication (two 5mg dronabinol tablets) two and a half hours prior to the inhaled medication (placebo for this group). Subjects will take two pills and smoke one cigarette, daily.	3) Placebo n=11 Participants Inhaled placebo is compared to oral placebo. Placebo: 20 people will be enrolled in this arm of the study and will receive study drug for 7 weeks. Subjects in this arm of the study will be instructed to take their oral medication (placebo) two and a half hours prior to the inhaled medication (placebo). Subjects will take two pills and smoke one cigarette, daily.
Change From Week 0 to Week 7 in the Rate of Torque Increase, Flexion	-0.0013 degrees/second Standard Deviation 0.0405	-0.0015 degrees/second Standard Deviation 0.0235	0.0043 degrees/second Standard Deviation 0.0161

PRIMARY outcome

Timeframe: Week 0, Week 7

Population: Only 28 subjects completed the study through the Wk 7 visit; Of these 28 subjects, only 26 subjects had Lido assessments at both the Week 0 and Week 7 study visits and were able to be analyzed for this outcome measure.

A modified servo-controlled torque motor system (Lido WorkSet II) was designed for this study to analyze the resistance to passive movement of the knee. It determines the amount of torque required to move the knee joint (without voluntary resistance) at high velocities (up to 200 degrees per second) and at slow velocities (as low as 10 degrees per second). The slow displacement torque is a measure of the passive resistance to movement (from the connective tissue and the non-contracting muscle) and the rapid displacement torques are the sum of the passive and active (involuntary) resistance. The active (involuntary) resistance is the result of the stretch reflex and correlates well with the clinical assessment of spasticity. The change was calculated by taking the value at Week 7 and subtracting the value at Week 0. A negative result indicates a decrease in the torque measured and correlates to a decrease in spasticity and a better outcome.

Outcome measures

Measure	1) Inhaled Cannabis n=7 Participants Inhaled cannabis is compared to oral placebo. Inhaled Cannabis: 20 people will be enrolled in this arm of the study and will receive study drug for 7 weeks. Subjects in this arm of the study will be instructed to take their oral medication (placebo for this group) two and a half hours prior to the inhaled medication. Subjects will take two pills and smoke one cannabis cigarette, daily.	2) Oral THC n=8 Participants Inhaled placebo is compared to oral THC. Oral THC: 20 people will be enrolled in this arm of the study and will receive study drug for 7 weeks. Subjects in this arm of the study will be instructed to take their oral medication (two 5mg dronabinol tablets) two and a half hours prior to the inhaled medication (placebo for this group). Subjects will take two pills and smoke one cigarette, daily.	3) Placebo n=11 Participants Inhaled placebo is compared to oral placebo. Placebo: 20 people will be enrolled in this arm of the study and will receive study drug for 7 weeks. Subjects in this arm of the study will be instructed to take their oral medication (placebo) two and a half hours prior to the inhaled medication (placebo). Subjects will take two pills and smoke one cigarette, daily.
LIDO Machine Score - Rate of Torque Increase, Extension	-0.0122 degrees/second Standard Deviation 0.0049	-0.0019 degrees/second Standard Deviation 0.0256	0.0186 degrees/second Standard Deviation 0.0240

SECONDARY outcome

Timeframe: Week 0, Week 3

Population: Only 28 subjects completed the study through the Wk 7 visit; 2 subjects who discontinued early (AE and withdraw by subject) were active at the Wk 3 visit and were included in the Wk 3 analysis; 28 total subjects had Ashworth assessments at both the Week 0 and Week 3 study visits and were able to be analyzed for this outcome measure.

The Modified Ashworth scale measures resistance during passive soft-tissue stretching. Spasticity is graded on a scale of 0 (no increase in muscle tone) to 4 (affected part rigid in flexion or extension). The highest score (flexion or extension), for the lower extremities only, was used for each subject. The change was calculated by taking the Week 3 score and subtracting the Week 0 score. A negative result indicates a decrease in spasticity and correlates to a better outcome.

Outcome measures

Measure	1) Inhaled Cannabis n=6 Participants Inhaled cannabis is compared to oral placebo. Inhaled Cannabis: 20 people will be enrolled in this arm of the study and will receive study drug for 7 weeks. Subjects in this arm of the study will be instructed to take their oral medication (placebo for this group) two and a half hours prior to the inhaled medication. Subjects will take two pills and smoke one cannabis cigarette, daily.	2) Oral THC n=11 Participants Inhaled placebo is compared to oral THC. Oral THC: 20 people will be enrolled in this arm of the study and will receive study drug for 7 weeks. Subjects in this arm of the study will be instructed to take their oral medication (two 5mg dronabinol tablets) two and a half hours prior to the inhaled medication (placebo for this group). Subjects will take two pills and smoke one cigarette, daily.	3) Placebo n=11 Participants Inhaled placebo is compared to oral placebo. Placebo: 20 people will be enrolled in this arm of the study and will receive study drug for 7 weeks. Subjects in this arm of the study will be instructed to take their oral medication (placebo) two and a half hours prior to the inhaled medication (placebo). Subjects will take two pills and smoke one cigarette, daily.
Change From Week 0 to Week 3 in Modified Ashworth Score (MAS)	-0.333 units on scale Standard Deviation 1.0328	0 units on scale Standard Deviation 0.8944	-0.4545 units on scale Standard Deviation 1.0357

SECONDARY outcome

Timeframe: Week 0, Week 7

Population: Only 28 subjects completed the study through the Wk 7 visit; Of these 28 subjects, only 27 subjects had Ashworth assessments at both the Week 0 and Week 7 study visits and were able to be analyzed for this outcome measure.

The Modified Ashworth scale measures resistance during passive soft-tissue stretching. Spasticity is graded on a scale of 0 (no increase in muscle tone) to 4 (affected part rigid in flexion or extension). The highest score (flexion or extension), for the lower extremities only, was used for each subject. The change was calculated by taking the Week 7 score and subtracting the Week 0 score. A negative result indicates a decrease in spasticity and correlates to a better outcome.

Outcome measures

Measure	1) Inhaled Cannabis n=7 Participants Inhaled cannabis is compared to oral placebo. Inhaled Cannabis: 20 people will be enrolled in this arm of the study and will receive study drug for 7 weeks. Subjects in this arm of the study will be instructed to take their oral medication (placebo for this group) two and a half hours prior to the inhaled medication. Subjects will take two pills and smoke one cannabis cigarette, daily.	2) Oral THC n=8 Participants Inhaled placebo is compared to oral THC. Oral THC: 20 people will be enrolled in this arm of the study and will receive study drug for 7 weeks. Subjects in this arm of the study will be instructed to take their oral medication (two 5mg dronabinol tablets) two and a half hours prior to the inhaled medication (placebo for this group). Subjects will take two pills and smoke one cigarette, daily.	3) Placebo n=12 Participants Inhaled placebo is compared to oral placebo. Placebo: 20 people will be enrolled in this arm of the study and will receive study drug for 7 weeks. Subjects in this arm of the study will be instructed to take their oral medication (placebo) two and a half hours prior to the inhaled medication (placebo). Subjects will take two pills and smoke one cigarette, daily.
Change From Week 0 to Week 7 in Modified Ashworth Score	1.1429 units on a scale Standard Deviation 0.6901	-0.3750 units on a scale Standard Deviation 0.5175	-0.2500 units on a scale Standard Deviation 0.7538

SECONDARY outcome

Timeframe: Week 0, Week 3

Population: Only 28 subjects completed the study through the Wk 7 visit; 2 subjects who discontinued early (AE and withdraw by subject) were active at the Wk 3 visit and were included in the Wk 3 analysis; 27 total subjects had Ambulation Index assessments at both the Week 0 and Week 3 study visits and were able to be analyzed for this outcome measure.

The AI is a 9-point rating scale used to assess mobility by evaluating the time and degree of assistance required to walk 25 feet. Scores range from 0 (asymptomatic, fully active) to 9 (restricted to wheelchair, unable to transfer self independently). Lower scores represent a better outcome for MS patients. For this study, the AI score was based on the results of the 25 Foot Walk test, also performed at the study visit. The change was calculated by taking the Week 3 score and subtracting the Week 0 score. A negative result for this outcome indicates an improvement in ambulation and correlates to a better outcome.

Outcome measures

Measure	1) Inhaled Cannabis n=6 Participants Inhaled cannabis is compared to oral placebo. Inhaled Cannabis: 20 people will be enrolled in this arm of the study and will receive study drug for 7 weeks. Subjects in this arm of the study will be instructed to take their oral medication (placebo for this group) two and a half hours prior to the inhaled medication. Subjects will take two pills and smoke one cannabis cigarette, daily.	2) Oral THC n=10 Participants Inhaled placebo is compared to oral THC. Oral THC: 20 people will be enrolled in this arm of the study and will receive study drug for 7 weeks. Subjects in this arm of the study will be instructed to take their oral medication (two 5mg dronabinol tablets) two and a half hours prior to the inhaled medication (placebo for this group). Subjects will take two pills and smoke one cigarette, daily.	3) Placebo n=11 Participants Inhaled placebo is compared to oral placebo. Placebo: 20 people will be enrolled in this arm of the study and will receive study drug for 7 weeks. Subjects in this arm of the study will be instructed to take their oral medication (placebo) two and a half hours prior to the inhaled medication (placebo). Subjects will take two pills and smoke one cigarette, daily.
Change From Week 0 to Week 3 in Ambulation Index (AI) Score	0 units on a scale Standard Deviation 0.6325	0 units on a scale Standard Deviation 0.6667	0.1818 units on a scale Standard Deviation 0.4045

SECONDARY outcome

Timeframe: Week 0, Week 7

Population: Only 28 subjects completed the study through the Wk 7 visit; Of these 28 subjects, all 28 subjects had Ambulation Index assessments at both the Week 0 and Week 7 study visits and were able to be analyzed for this outcome measure.

The AI is a 9-point rating scale used to assess mobility by evaluating the time and degree of assistance required to walk 25 feet. Scores range from 0 (asymptomatic, fully active) to 9 (restricted to wheelchair, unable to transfer self independently). Lower scores represent a better outcome for MS patients. For this study, the AI score was based on the results of the 25 Foot Walk test, also performed at the study visit. The change was calculated by taking the Week 7 score and subtracting the Week 0 score. A negative result for this outcome indicates an improvement in ambulation and correlates to a better outcome.

Outcome measures

Measure	1) Inhaled Cannabis n=7 Participants Inhaled cannabis is compared to oral placebo. Inhaled Cannabis: 20 people will be enrolled in this arm of the study and will receive study drug for 7 weeks. Subjects in this arm of the study will be instructed to take their oral medication (placebo for this group) two and a half hours prior to the inhaled medication. Subjects will take two pills and smoke one cannabis cigarette, daily.	2) Oral THC n=9 Participants Inhaled placebo is compared to oral THC. Oral THC: 20 people will be enrolled in this arm of the study and will receive study drug for 7 weeks. Subjects in this arm of the study will be instructed to take their oral medication (two 5mg dronabinol tablets) two and a half hours prior to the inhaled medication (placebo for this group). Subjects will take two pills and smoke one cigarette, daily.	3) Placebo n=12 Participants Inhaled placebo is compared to oral placebo. Placebo: 20 people will be enrolled in this arm of the study and will receive study drug for 7 weeks. Subjects in this arm of the study will be instructed to take their oral medication (placebo) two and a half hours prior to the inhaled medication (placebo). Subjects will take two pills and smoke one cigarette, daily.
Change From Week 0 to Week 7 in Ambulation Index (AI) Score	0.1429 units on a scale Standard Deviation 0.3780	0.4444 units on a scale Standard Deviation 0.5270	0.3333 units on a scale Standard Deviation 0.6513

SECONDARY outcome

Timeframe: Week 0, Week 3

Population: Only 28 subjects completed the study through the Wk 7 visit; 2 subjects who discontinued early (AE and withdraw by subject) were active at the Wk 3 visit and were included in the Wk 3 analysis; 22 total subjects had 25 Foot Walk tests performed at both the Week 0 and Week 3 study visits and were able to be analyzed for this outcome measure.

The Timed 25 Foot Walk is a quantitative measure of lower extremity function. The patient is instructed to walk on a marked 25-foot course, as quickly and as safely as possible. The patient is allowed to use his/her typical walking aid, if applicable. The task is completed twice and the average time of the two trials was used for this outcome measure. The change was calculated by taking the Week 3 time and subtracting the Week 0 time. A negative result indicates an improvement in walking ability and correlates to a better outcome.

Outcome measures

Measure	1) Inhaled Cannabis n=5 Participants Inhaled cannabis is compared to oral placebo. Inhaled Cannabis: 20 people will be enrolled in this arm of the study and will receive study drug for 7 weeks. Subjects in this arm of the study will be instructed to take their oral medication (placebo for this group) two and a half hours prior to the inhaled medication. Subjects will take two pills and smoke one cannabis cigarette, daily.	2) Oral THC n=7 Participants Inhaled placebo is compared to oral THC. Oral THC: 20 people will be enrolled in this arm of the study and will receive study drug for 7 weeks. Subjects in this arm of the study will be instructed to take their oral medication (two 5mg dronabinol tablets) two and a half hours prior to the inhaled medication (placebo for this group). Subjects will take two pills and smoke one cigarette, daily.	3) Placebo n=10 Participants Inhaled placebo is compared to oral placebo. Placebo: 20 people will be enrolled in this arm of the study and will receive study drug for 7 weeks. Subjects in this arm of the study will be instructed to take their oral medication (placebo) two and a half hours prior to the inhaled medication (placebo). Subjects will take two pills and smoke one cigarette, daily.
Change From Week 0 to Week 3 in 25 Foot Walk Time	-0.0100 seconds Standard Deviation 1.6300	-3.3714 seconds Standard Deviation 4.5605	0.1400 seconds Standard Deviation 1.9998

SECONDARY outcome

Timeframe: Week 0, Week 7

Population: Only 28 subjects completed the study through the Wk 7 visit; Of these 28 subjects, only 26 subjects had 25 Foot Walk tests performed at both the Week 0 and Week 7 study visits and were able to be analyzed for this outcome measure.

The Timed 25 Foot Walk is a quantitative measure of lower extremity function. The patient is instructed to walk on a marked 25-foot course, as quickly and as safely as possible. The patient is allowed to use his/her typical walking aid, if applicable. The task is completed twice and the average time of the two trials was used for this outcome measure. The change was calculated by taking the Week 7 time and subtracting the Week 0 time. A negative result indicates an improvement in walking ability and correlates to a better outcome.

Outcome measures

Measure	1) Inhaled Cannabis n=6 Participants Inhaled cannabis is compared to oral placebo. Inhaled Cannabis: 20 people will be enrolled in this arm of the study and will receive study drug for 7 weeks. Subjects in this arm of the study will be instructed to take their oral medication (placebo for this group) two and a half hours prior to the inhaled medication. Subjects will take two pills and smoke one cannabis cigarette, daily.	2) Oral THC n=9 Participants Inhaled placebo is compared to oral THC. Oral THC: 20 people will be enrolled in this arm of the study and will receive study drug for 7 weeks. Subjects in this arm of the study will be instructed to take their oral medication (two 5mg dronabinol tablets) two and a half hours prior to the inhaled medication (placebo for this group). Subjects will take two pills and smoke one cigarette, daily.	3) Placebo n=11 Participants Inhaled placebo is compared to oral placebo. Placebo: 20 people will be enrolled in this arm of the study and will receive study drug for 7 weeks. Subjects in this arm of the study will be instructed to take their oral medication (placebo) two and a half hours prior to the inhaled medication (placebo). Subjects will take two pills and smoke one cigarette, daily.
Change From Week 0 to Week 7 in 25 Foot Walk Time	-2.6000 seconds Standard Deviation 5.6240	3.3667 seconds Standard Deviation 9.7660	2.2773 seconds Standard Deviation 6.3507

SECONDARY outcome

Timeframe: Week 0, Week 3

Population: Only 28 subjects completed the study through the Wk 7 visit; 2 subjects who discontinued early (AE and withdraw by subject) were active at the Wk 3 visit and were included in the Wk 3 analysis; 26 total subjects had 9 Hole Peg tests (dominant hand) at both the Week 0 and Week 3 study visits and were able to be analyzed for this outcome measure.

The 9 hold peg test is a quantitative measure of upper extremity (arm and hand function). Patients are instructed to fill an 9 hole peg board with 1 peg at a time and then immediately remove the pegs, 1 at a time. The dominant hand is tested twice and the average time was used for this outcome measure. The change was calculated by taking the Week 3 time and subtracting the Week 0 time.

A negative result indicates an improvement in arm and hand function and correlates with a better outcome.

Outcome measures

Measure	1) Inhaled Cannabis n=7 Participants Inhaled cannabis is compared to oral placebo. Inhaled Cannabis: 20 people will be enrolled in this arm of the study and will receive study drug for 7 weeks. Subjects in this arm of the study will be instructed to take their oral medication (placebo for this group) two and a half hours prior to the inhaled medication. Subjects will take two pills and smoke one cannabis cigarette, daily.	2) Oral THC n=9 Participants Inhaled placebo is compared to oral THC. Oral THC: 20 people will be enrolled in this arm of the study and will receive study drug for 7 weeks. Subjects in this arm of the study will be instructed to take their oral medication (two 5mg dronabinol tablets) two and a half hours prior to the inhaled medication (placebo for this group). Subjects will take two pills and smoke one cigarette, daily.	3) Placebo n=10 Participants Inhaled placebo is compared to oral placebo. Placebo: 20 people will be enrolled in this arm of the study and will receive study drug for 7 weeks. Subjects in this arm of the study will be instructed to take their oral medication (placebo) two and a half hours prior to the inhaled medication (placebo). Subjects will take two pills and smoke one cigarette, daily.
Change From Week 0 to Week 3 in 9 Hole Peg Test (Dominant Hand) Time	-0.8929 seconds Standard Deviation 3.2680	-1.5244 seconds Standard Deviation 7.8972	1.4450 seconds Standard Deviation 8.7548

SECONDARY outcome

Timeframe: Week 0, Week 7

Population: Only 28 subjects completed the study through the Wk 7 visit; Of these 28 subjects, only 27 subjects had 9 Hole Peg tests (dominant hand) performed at both the Week 0 and Week 7 study visits and were able to be analyzed for this outcome measure.

The 9 hold peg test is a quantitative measure of upper extremity (arm and hand function). Patients are instructed to fill an 9 hole peg board with 1 peg at a time and then immediately remove the pegs, 1 at a time. The dominant hand is tested twice and the average time was used for this outcome measure. The change was calculated by taking the Week 7 time and subtracting the Week 0 time.

A negative result indicates an improvement in arm and hand function and correlates with a better outcome.

Outcome measures

Measure	1) Inhaled Cannabis n=7 Participants Inhaled cannabis is compared to oral placebo. Inhaled Cannabis: 20 people will be enrolled in this arm of the study and will receive study drug for 7 weeks. Subjects in this arm of the study will be instructed to take their oral medication (placebo for this group) two and a half hours prior to the inhaled medication. Subjects will take two pills and smoke one cannabis cigarette, daily.	2) Oral THC n=9 Participants Inhaled placebo is compared to oral THC. Oral THC: 20 people will be enrolled in this arm of the study and will receive study drug for 7 weeks. Subjects in this arm of the study will be instructed to take their oral medication (two 5mg dronabinol tablets) two and a half hours prior to the inhaled medication (placebo for this group). Subjects will take two pills and smoke one cigarette, daily.	3) Placebo n=11 Participants Inhaled placebo is compared to oral placebo. Placebo: 20 people will be enrolled in this arm of the study and will receive study drug for 7 weeks. Subjects in this arm of the study will be instructed to take their oral medication (placebo) two and a half hours prior to the inhaled medication (placebo). Subjects will take two pills and smoke one cigarette, daily.
Change From Week 0 to Week 7 in 9 Hole Peg Test (Dominant Hand) Time	5.6714 seconds Standard Deviation 20.9260	1.4756 seconds Standard Deviation 11.3974	-0.4991 seconds Standard Deviation 7.2244

SECONDARY outcome

Timeframe: Week 0, Week 3

Population: Only 28 subjects completed the study through the Wk 7 visit; 2 subjects who discontinued early (AE and withdraw by subject) were active at the Wk 3 visit and were included in the Wk 3 analysis; 26 total subjects had 9 Hole peg tests (non-dom. hand) at both the Week 0 and Week 3 study visits and were able to be analyzed for this outcome measure.

The 9 hold peg test is a quantitative measure of upper extremity (arm and hand function). Patients are instructed to fill an 9 hole peg board with 1 peg at a time and then immediately remove the pegs, 1 at a time. The non-dominant hand is tested twice and the average time was used for this outcome measure. The change was calculated by taking the Week 3 time and subtracting the Week 0 time.

A negative result indicates an improvement in arm and hand function and correlates with a better outcome.

Outcome measures

Measure	1) Inhaled Cannabis n=6 Participants Inhaled cannabis is compared to oral placebo. Inhaled Cannabis: 20 people will be enrolled in this arm of the study and will receive study drug for 7 weeks. Subjects in this arm of the study will be instructed to take their oral medication (placebo for this group) two and a half hours prior to the inhaled medication. Subjects will take two pills and smoke one cannabis cigarette, daily.	2) Oral THC n=11 Participants Inhaled placebo is compared to oral THC. Oral THC: 20 people will be enrolled in this arm of the study and will receive study drug for 7 weeks. Subjects in this arm of the study will be instructed to take their oral medication (two 5mg dronabinol tablets) two and a half hours prior to the inhaled medication (placebo for this group). Subjects will take two pills and smoke one cigarette, daily.	3) Placebo n=9 Participants Inhaled placebo is compared to oral placebo. Placebo: 20 people will be enrolled in this arm of the study and will receive study drug for 7 weeks. Subjects in this arm of the study will be instructed to take their oral medication (placebo) two and a half hours prior to the inhaled medication (placebo). Subjects will take two pills and smoke one cigarette, daily.
Change From Week 0 to Week 3 in 9 Hole Peg Test (Non- Dominant Hand) Time	-1.0250 seconds Standard Deviation 2.5514	2.1318 seconds Standard Deviation 10.7380	-1.3933 seconds Standard Deviation 3.0505

SECONDARY outcome

Timeframe: Week 0, Week 7

Population: Only 28 subjects completed the study through the Wk 7 visit; Of these 28 subjects, only 25 subjects had 9 Hole Peg tests (non-dom. hand) performed at both the Week 0 and Week 7 study visits and were able to be analyzed for this outcome measure.

The 9 hold peg test is a quantitative measure of upper extremity (arm and hand function). Patients are instructed to fill an 9 hole peg board with 1 peg at a time and then immediately remove the pegs, 1 at a time. The dominant hand is tested twice and the average time was used for this outcome measure. The change was calculated by taking the Week 7 time and subtracting the Week 0 time.

A negative result indicates an improvement in arm and hand function and correlates with a better outcome.

Outcome measures

Measure	1) Inhaled Cannabis n=6 Participants Inhaled cannabis is compared to oral placebo. Inhaled Cannabis: 20 people will be enrolled in this arm of the study and will receive study drug for 7 weeks. Subjects in this arm of the study will be instructed to take their oral medication (placebo for this group) two and a half hours prior to the inhaled medication. Subjects will take two pills and smoke one cannabis cigarette, daily.	2) Oral THC n=9 Participants Inhaled placebo is compared to oral THC. Oral THC: 20 people will be enrolled in this arm of the study and will receive study drug for 7 weeks. Subjects in this arm of the study will be instructed to take their oral medication (two 5mg dronabinol tablets) two and a half hours prior to the inhaled medication (placebo for this group). Subjects will take two pills and smoke one cigarette, daily.	3) Placebo n=10 Participants Inhaled placebo is compared to oral placebo. Placebo: 20 people will be enrolled in this arm of the study and will receive study drug for 7 weeks. Subjects in this arm of the study will be instructed to take their oral medication (placebo) two and a half hours prior to the inhaled medication (placebo). Subjects will take two pills and smoke one cigarette, daily.
Change From Week 0 to Week 7 in 9 Hole Peg Test (Non- Dominant Hand) Time	-2.1083 seconds Standard Deviation 1.3786	-3.9556 seconds Standard Deviation 10.5019	0.5530 seconds Standard Deviation 4.8470

SECONDARY outcome

Timeframe: Week 0, Week 3

Population: Only 28 subjects completed the study through the Wk 7 visit; 2 subjects who discontinued early (AE and withdraw by subject) were active at the Wk 3 visit and were included in the Wk 3 analysis; 29 total subjects had PASAT assessments at both the Week 0 and Week 3 study visits and were able to be analyzed for this outcome measure.

The PASAT is a measure of cognitive function that specifically assesses auditory information processing speed and flexibility, as well as calculation ability; The test is presented via recording on a CD to control the rate of stimulus presentation. Single digits are presented every 3 seconds and the patient must add each new digit to the one immediately prior to it. The test score is the number of correct sums given (out of a possible 60) in each trial. There are 2 test forms, A and B. The forms were alternated and at least 1 practice test (10 sums) was performed prior to each trial. The change was calculated by taking the Week 3 score and subtracting the Week 0 score. A negative result indicates an improvement in performance and correlates with a better outcome.

Outcome measures

Measure	1) Inhaled Cannabis n=7 Participants Inhaled cannabis is compared to oral placebo. Inhaled Cannabis: 20 people will be enrolled in this arm of the study and will receive study drug for 7 weeks. Subjects in this arm of the study will be instructed to take their oral medication (placebo for this group) two and a half hours prior to the inhaled medication. Subjects will take two pills and smoke one cannabis cigarette, daily.	2) Oral THC n=11 Participants Inhaled placebo is compared to oral THC. Oral THC: 20 people will be enrolled in this arm of the study and will receive study drug for 7 weeks. Subjects in this arm of the study will be instructed to take their oral medication (two 5mg dronabinol tablets) two and a half hours prior to the inhaled medication (placebo for this group). Subjects will take two pills and smoke one cigarette, daily.	3) Placebo n=11 Participants Inhaled placebo is compared to oral placebo. Placebo: 20 people will be enrolled in this arm of the study and will receive study drug for 7 weeks. Subjects in this arm of the study will be instructed to take their oral medication (placebo) two and a half hours prior to the inhaled medication (placebo). Subjects will take two pills and smoke one cigarette, daily.
Change From Week 0 to Week 3 in Paced Auditory Serial Addition Test (PASAT) Score	-3.7143 number correct Standard Deviation 10.0285	0.3636 number correct Standard Deviation 6.0212	2.5455 number correct Standard Deviation 8.8472

SECONDARY outcome

Timeframe: Week 0, Week 7

Population: Only 28 subjects completed the study through the Wk 7 visit; Of these 28 subjects, all 28 subjects had PASAT assessments at both the Week 0 and Week 7 study visits and were able to be analyzed for this outcome measure.

The PASAT is a measure of cognitive function that specifically assesses auditory information processing speed and flexibility, as well as calculation ability; The test is presented via recording on a CD to control the rate of stimulus presentation. Single digits are presented every 3 seconds and the patient must add each new digit to the one immediately prior to it. The test score is the number of correct sums given (out of a possible 60) in each trial. There are 2 test forms, A and B. The forms were alternated and at least 1 practice test (10 sums) was performed prior to each trial. The change was calculated by taking the Week 7 score and subtracting the Week 0 score. A negative result indicates an improvement in performance and correlates with a better outcome.

Outcome measures

Measure	1) Inhaled Cannabis n=7 Participants Inhaled cannabis is compared to oral placebo. Inhaled Cannabis: 20 people will be enrolled in this arm of the study and will receive study drug for 7 weeks. Subjects in this arm of the study will be instructed to take their oral medication (placebo for this group) two and a half hours prior to the inhaled medication. Subjects will take two pills and smoke one cannabis cigarette, daily.	2) Oral THC n=9 Participants Inhaled placebo is compared to oral THC. Oral THC: 20 people will be enrolled in this arm of the study and will receive study drug for 7 weeks. Subjects in this arm of the study will be instructed to take their oral medication (two 5mg dronabinol tablets) two and a half hours prior to the inhaled medication (placebo for this group). Subjects will take two pills and smoke one cigarette, daily.	3) Placebo n=12 Participants Inhaled placebo is compared to oral placebo. Placebo: 20 people will be enrolled in this arm of the study and will receive study drug for 7 weeks. Subjects in this arm of the study will be instructed to take their oral medication (placebo) two and a half hours prior to the inhaled medication (placebo). Subjects will take two pills and smoke one cigarette, daily.
Change From Week 0 to Week 7 in Paced Auditory Serial Addition Test (PASAT) Score	2.0 number correct Standard Deviation 6.3770	0.1111 number correct Standard Deviation 5.6887	7.9167 number correct Standard Deviation 6.1120

SECONDARY outcome

Timeframe: Week 0, Week 3

Population: Only 28 subjects completed the study through the Wk 7 visit; 2 subjects who discontinued early (AE and withdraw by subject) were active at the Wk 3 visit and were included in the Wk 3 analysis; 27 total subjects had FS Vision assessments at both the Week 0 and Week 3 study visits and were able to be analyzed for this outcome measure.

The EDSS is a method of quantifying disability in MS patients and monitoring changes in the level of disability over time. The EDSS quantifies disability in 7 functional systems (FS): visual, brainstem, pyramidal, cerebellar, sensory, bowel and bladder, and cerebral, and includes a measure of ambulation. Neurostatus version 10/2002 was used for this study. The FS Vision score is determined by a 7-point scale, with 0 being the lowest (normal) and 6 being the highest (grade 5 plus maximal visual acuity of better eye of 20/60 (0.3) or less).

Higher values indicate more impaired vision. The change was calculated by taking the Week 3 score and subtracting the Week 0 score. A negative result indicates an improvement in vision and correlates to a better outcome.

Outcome measures

Measure	1) Inhaled Cannabis n=6 Participants Inhaled cannabis is compared to oral placebo. Inhaled Cannabis: 20 people will be enrolled in this arm of the study and will receive study drug for 7 weeks. Subjects in this arm of the study will be instructed to take their oral medication (placebo for this group) two and a half hours prior to the inhaled medication. Subjects will take two pills and smoke one cannabis cigarette, daily.	2) Oral THC n=10 Participants Inhaled placebo is compared to oral THC. Oral THC: 20 people will be enrolled in this arm of the study and will receive study drug for 7 weeks. Subjects in this arm of the study will be instructed to take their oral medication (two 5mg dronabinol tablets) two and a half hours prior to the inhaled medication (placebo for this group). Subjects will take two pills and smoke one cigarette, daily.	3) Placebo n=11 Participants Inhaled placebo is compared to oral placebo. Placebo: 20 people will be enrolled in this arm of the study and will receive study drug for 7 weeks. Subjects in this arm of the study will be instructed to take their oral medication (placebo) two and a half hours prior to the inhaled medication (placebo). Subjects will take two pills and smoke one cigarette, daily.
Change From Week 0 to Week 3 in Functional System Score - Vision	0.1667 units on a scale Standard Deviation 0.4082	-0.3000 units on a scale Standard Deviation 0.2517	-1.0 units on a scale Standard Deviation 0.6325

SECONDARY outcome

Timeframe: Week 0, Week 7

Population: Only 28 subjects completed the study through the Wk 7 visit; Of these 28 subjects, only 27 subjects had FS Vision assessments at both the Week 0 and Week 7 study visits and were able to be analyzed for this outcome measure.

The EDSS is a method of quantifying disability in MS patients and monitoring changes in the level of disability over time. The EDSS quantifies disability in 7 functional systems (FS): visual, brainstem, pyramidal, cerebellar, sensory, bowel and bladder, and cerebral, and includes a measure of ambulation. Neurostatus version 10/2002 was used for this study. The FS Vision score is determined by a 7-point scale, with 0 being the lowest (normal) and 6 being the highest (grade 5 plus maximal visual acuity of better eye of 20/60 (0.3) or less).

Higher values indicate more impaired vision. The change was calculated by taking the Week 7 score and subtracting the Week 0 score. A negative result indicates an improvement in vision and correlates to a better outcome.

Outcome measures

Measure	1) Inhaled Cannabis n=7 Participants Inhaled cannabis is compared to oral placebo. Inhaled Cannabis: 20 people will be enrolled in this arm of the study and will receive study drug for 7 weeks. Subjects in this arm of the study will be instructed to take their oral medication (placebo for this group) two and a half hours prior to the inhaled medication. Subjects will take two pills and smoke one cannabis cigarette, daily.	2) Oral THC n=8 Participants Inhaled placebo is compared to oral THC. Oral THC: 20 people will be enrolled in this arm of the study and will receive study drug for 7 weeks. Subjects in this arm of the study will be instructed to take their oral medication (two 5mg dronabinol tablets) two and a half hours prior to the inhaled medication (placebo for this group). Subjects will take two pills and smoke one cigarette, daily.	3) Placebo n=12 Participants Inhaled placebo is compared to oral placebo. Placebo: 20 people will be enrolled in this arm of the study and will receive study drug for 7 weeks. Subjects in this arm of the study will be instructed to take their oral medication (placebo) two and a half hours prior to the inhaled medication (placebo). Subjects will take two pills and smoke one cigarette, daily.
Change From Week 0 to Week 7 in Functional System Score - Vision	-0.1429 units on a scale Standard Deviation 0.6901	-0.3750 units on a scale Standard Deviation 0.9161	-0.6667 units on a scale Standard Deviation 0.8876

SECONDARY outcome

Timeframe: Week 0, Week 3

Population: Only 28 subjects completed the study through the Wk 7 visit; 2 subjects who discontinued early (AE and withdraw by subject) were active at the Wk 3 visit and were included in the Wk 3 analysis; 28 total subjects had FS Brainstem assessments at both the Week 0 and Week 3 study visits and were able to be analyzed for this outcome measure.

The EDSS is a method of quantifying disability in MS patients and monitoring changes in the level of disability over time. The EDSS quantifies disability in 7 functional systems (FS): visual, brainstem, pyramidal, cerebellar, sensory, bowel and bladder, and cerebral, and includes a measure of ambulation. Neurostatus version 10/2002 was used for this study. The FS Brainstem score is determined by a 6-point scale, with 0 being the lowest (normal) and 5 being the highest (inability to swallow or speak). Higher values indicate more impaired function. The change was calculated by taking the Week 3 score and subtracting the Week 0 score. A negative result indicates an improvement in function and correlates to a better outcome.

Outcome measures

Measure	1) Inhaled Cannabis n=6 Participants Inhaled cannabis is compared to oral placebo. Inhaled Cannabis: 20 people will be enrolled in this arm of the study and will receive study drug for 7 weeks. Subjects in this arm of the study will be instructed to take their oral medication (placebo for this group) two and a half hours prior to the inhaled medication. Subjects will take two pills and smoke one cannabis cigarette, daily.	2) Oral THC n=11 Participants Inhaled placebo is compared to oral THC. Oral THC: 20 people will be enrolled in this arm of the study and will receive study drug for 7 weeks. Subjects in this arm of the study will be instructed to take their oral medication (two 5mg dronabinol tablets) two and a half hours prior to the inhaled medication (placebo for this group). Subjects will take two pills and smoke one cigarette, daily.	3) Placebo n=11 Participants Inhaled placebo is compared to oral placebo. Placebo: 20 people will be enrolled in this arm of the study and will receive study drug for 7 weeks. Subjects in this arm of the study will be instructed to take their oral medication (placebo) two and a half hours prior to the inhaled medication (placebo). Subjects will take two pills and smoke one cigarette, daily.
Change From Week 0 to Week 3 in Functional System Score - Brainstem	0.1667 units on a scale Standard Deviation 0.4082	-0.0909 units on a scale Standard Deviation 0.8312	0.2727 units on a scale Standard Deviation 1.4206

SECONDARY outcome

Timeframe: Week 0, Week 7

Population: Only 28 subjects completed the study through the Wk 7 visit; Of these 28 subjects, only 27 subjects had FS Brainstem assessments at both the Week 0 and Week 7 study visits and were able to be analyzed for this outcome measure.

The EDSS is a method of quantifying disability in MS patients and monitoring changes in the level of disability over time. The EDSS quantifies disability in 7 functional systems (FS): visual, brainstem, pyramidal, cerebellar, sensory, bowel and bladder, and cerebral, and includes a measure of ambulation. Neurostatus version 10/2002 was used for this study. The FS Brainstem score is determined by a 6-point scale, with 0 being the lowest (normal) and 5 being the highest (inability to swallow or speak). Higher values indicate more impaired function. The change was calculated by taking the Week 7 score and subtracting the Week 0 score. A negative result indicates an improvement in function and correlates to a better outcome.

Outcome measures

Measure	1) Inhaled Cannabis n=7 Participants Inhaled cannabis is compared to oral placebo. Inhaled Cannabis: 20 people will be enrolled in this arm of the study and will receive study drug for 7 weeks. Subjects in this arm of the study will be instructed to take their oral medication (placebo for this group) two and a half hours prior to the inhaled medication. Subjects will take two pills and smoke one cannabis cigarette, daily.	2) Oral THC n=8 Participants Inhaled placebo is compared to oral THC. Oral THC: 20 people will be enrolled in this arm of the study and will receive study drug for 7 weeks. Subjects in this arm of the study will be instructed to take their oral medication (two 5mg dronabinol tablets) two and a half hours prior to the inhaled medication (placebo for this group). Subjects will take two pills and smoke one cigarette, daily.	3) Placebo n=12 Participants Inhaled placebo is compared to oral placebo. Placebo: 20 people will be enrolled in this arm of the study and will receive study drug for 7 weeks. Subjects in this arm of the study will be instructed to take their oral medication (placebo) two and a half hours prior to the inhaled medication (placebo). Subjects will take two pills and smoke one cigarette, daily.
Change From Week 0 to Week 7 in Functional System Score - Brainstem	-0.1429 units on a scale Standard Deviation 0.6901	0.6250 units on a scale Standard Deviation 1.0607	0.1667 units on a scale Standard Deviation 1.0299

SECONDARY outcome

Timeframe: Week 0, Week 3

Population: Only 28 subjects completed the study through the Wk 7 visit; 2 subjects who discontinued early (AE and withdraw by subject) were active at the Wk 3 visit and were included in the Wk 3 analysis; 28 total subjects had FS Pyramidal assessments at both the Week 0 and Week 3 study visits and were able to be analyzed for this outcome measure.

The EDSS is a method of quantifying disability in MS patients and monitoring changes in the level of disability over time. The EDSS quantifies disability in 7 functional systems (FS): visual, brainstem, pyramidal, cerebellar, sensory, bowel and bladder, and cerebral, and includes a measure of ambulation. Neurostatus version 10/2002 was used for this study. The FS Pyramidal score is determined by a 7-point scale, with 0 being the lowest (normal) and 6 being the highest (tetraplegia (grade 0 or 1 in all muscle groups of upper and lower limbs). Higher values indicate more impaired function. The change was calculated by taking the Week 3 score and subtracting the Week 0 score. A negative result indicates an improvement in function and correlates to a better outcome.

Outcome measures

Measure	1) Inhaled Cannabis n=6 Participants Inhaled cannabis is compared to oral placebo. Inhaled Cannabis: 20 people will be enrolled in this arm of the study and will receive study drug for 7 weeks. Subjects in this arm of the study will be instructed to take their oral medication (placebo for this group) two and a half hours prior to the inhaled medication. Subjects will take two pills and smoke one cannabis cigarette, daily.	2) Oral THC n=11 Participants Inhaled placebo is compared to oral THC. Oral THC: 20 people will be enrolled in this arm of the study and will receive study drug for 7 weeks. Subjects in this arm of the study will be instructed to take their oral medication (two 5mg dronabinol tablets) two and a half hours prior to the inhaled medication (placebo for this group). Subjects will take two pills and smoke one cigarette, daily.	3) Placebo n=11 Participants Inhaled placebo is compared to oral placebo. Placebo: 20 people will be enrolled in this arm of the study and will receive study drug for 7 weeks. Subjects in this arm of the study will be instructed to take their oral medication (placebo) two and a half hours prior to the inhaled medication (placebo). Subjects will take two pills and smoke one cigarette, daily.
Change From Week 0 to Week 3 in Functional System Score - Pyramidal	0.3333 units on a scale Standard Deviation 1.2111	-0.1818 units on a scale Standard Deviation 0.6030	0 units on a scale Standard Deviation 0.6325

SECONDARY outcome

Timeframe: Week 0, Week 7

Population: Only 28 subjects completed the study through the Wk 7 visit; Of these 28 subjects, only 27 subjects had FS Pyramidal assessments at both the Week 0 and Week 7 study visits and were able to be analyzed for this outcome measure.

The EDSS is a method of quantifying disability in MS patients and monitoring changes in the level of disability over time. The EDSS quantifies disability in 7 functional systems (FS): visual, brainstem, pyramidal, cerebellar, sensory, bowel and bladder, and cerebral, and includes a measure of ambulation. Neurostatus version 10/2002 was used for this study. The FS Pyramidal score is determined by a 7-point scale, with 0 being the lowest (normal) and 6 being the highest (tetraplegia (grade 0 or 1 in all muscle groups of upper and lower limbs). Higher values indicate more impaired function. The change was calculated by taking the Week 7 score and subtracting the Week 0 score. A negative result indicates an improvement in function and correlates to a better outcome.

Outcome measures

Measure	1) Inhaled Cannabis n=7 Participants Inhaled cannabis is compared to oral placebo. Inhaled Cannabis: 20 people will be enrolled in this arm of the study and will receive study drug for 7 weeks. Subjects in this arm of the study will be instructed to take their oral medication (placebo for this group) two and a half hours prior to the inhaled medication. Subjects will take two pills and smoke one cannabis cigarette, daily.	2) Oral THC n=8 Participants Inhaled placebo is compared to oral THC. Oral THC: 20 people will be enrolled in this arm of the study and will receive study drug for 7 weeks. Subjects in this arm of the study will be instructed to take their oral medication (two 5mg dronabinol tablets) two and a half hours prior to the inhaled medication (placebo for this group). Subjects will take two pills and smoke one cigarette, daily.	3) Placebo n=12 Participants Inhaled placebo is compared to oral placebo. Placebo: 20 people will be enrolled in this arm of the study and will receive study drug for 7 weeks. Subjects in this arm of the study will be instructed to take their oral medication (placebo) two and a half hours prior to the inhaled medication (placebo). Subjects will take two pills and smoke one cigarette, daily.
Change From Week 0 to Week 7 in Functional System Score - Pyramidal	0.4286 units on a scale Standard Deviation 0.9759	-0.5000 units on a scale Standard Deviation 1.0690	0.0833 units on a scale Standard Deviation 0.6686

SECONDARY outcome

Timeframe: Week 0, Week 3

Population: Only 28 subjects completed the study through the Wk 7 visit; 2 subjects who discontinued early (AE and withdraw by subject) were active at the Wk 3 visit and were included in the Wk 3 analysis; 27 total subjects had FS Cerebellar assessments at both the Week 0 and Week 3 study visits and were able to be analyzed for this outcome measure.

The EDSS is a method of quantifying disability in MS patients and monitoring changes in the level of disability over time. The EDSS quantifies disability in 7 functional systems (FS): visual, brainstem, pyramidal, cerebellar, sensory, bowel and bladder, and cerebral, and includes a measure of ambulation. Neurostatus version 10/2002 was used for this study. The FS Cerebellar score is determined by a 6-point scale, with 0 being the lowest (normal) and 5 being the highest (unable to perform coordinated movements due to ataxia). Higher values indicate more impaired function. The change was calculated by taking the Week 3 score and subtracting the Week 0 score. A negative result indicates an improvement in function and correlates to a better outcome.

Outcome measures

Measure	1) Inhaled Cannabis n=6 Participants Inhaled cannabis is compared to oral placebo. Inhaled Cannabis: 20 people will be enrolled in this arm of the study and will receive study drug for 7 weeks. Subjects in this arm of the study will be instructed to take their oral medication (placebo for this group) two and a half hours prior to the inhaled medication. Subjects will take two pills and smoke one cannabis cigarette, daily.	2) Oral THC n=10 Participants Inhaled placebo is compared to oral THC. Oral THC: 20 people will be enrolled in this arm of the study and will receive study drug for 7 weeks. Subjects in this arm of the study will be instructed to take their oral medication (two 5mg dronabinol tablets) two and a half hours prior to the inhaled medication (placebo for this group). Subjects will take two pills and smoke one cigarette, daily.	3) Placebo n=11 Participants Inhaled placebo is compared to oral placebo. Placebo: 20 people will be enrolled in this arm of the study and will receive study drug for 7 weeks. Subjects in this arm of the study will be instructed to take their oral medication (placebo) two and a half hours prior to the inhaled medication (placebo). Subjects will take two pills and smoke one cigarette, daily.
Change From Week 0 to Week 3 in Functional System Score - Cerebellar	-0.50 units on a scale Standard Deviation 0.5477	-0.20 units on a scale Standard Deviation 0.9189	-0.0909 units on a scale Standard Deviation 0.5394

SECONDARY outcome

Timeframe: Week 0, Week 7

Population: Only 28 subjects completed the study through the Wk 7 visit; Of these 28 subjects, only 27 subjects had FS Cerebellar assessments at both the Week 0 and Week 7 study visits and were able to be analyzed for this outcome measure.

The EDSS is a method of quantifying disability in MS patients and monitoring changes in the level of disability over time. The EDSS quantifies disability in 7 functional systems (FS): visual, brainstem, pyramidal, cerebellar, sensory, bowel and bladder, and cerebral, and includes a measure of ambulation. Neurostatus version 10/2002 was used for this study. The FS Cerebellar score is determined by a 6-point scale, with 0 being the lowest (normal) and 5 being the highest (unable to perform coordinated movements due to ataxia). Higher values indicate more impaired function. The change was calculated by taking the Week 7 score and subtracting the Week 0 score. A negative result indicates an improvement in function and correlates to a better outcome.

Outcome measures

Measure	1) Inhaled Cannabis n=7 Participants Inhaled cannabis is compared to oral placebo. Inhaled Cannabis: 20 people will be enrolled in this arm of the study and will receive study drug for 7 weeks. Subjects in this arm of the study will be instructed to take their oral medication (placebo for this group) two and a half hours prior to the inhaled medication. Subjects will take two pills and smoke one cannabis cigarette, daily.	2) Oral THC n=8 Participants Inhaled placebo is compared to oral THC. Oral THC: 20 people will be enrolled in this arm of the study and will receive study drug for 7 weeks. Subjects in this arm of the study will be instructed to take their oral medication (two 5mg dronabinol tablets) two and a half hours prior to the inhaled medication (placebo for this group). Subjects will take two pills and smoke one cigarette, daily.	3) Placebo n=12 Participants Inhaled placebo is compared to oral placebo. Placebo: 20 people will be enrolled in this arm of the study and will receive study drug for 7 weeks. Subjects in this arm of the study will be instructed to take their oral medication (placebo) two and a half hours prior to the inhaled medication (placebo). Subjects will take two pills and smoke one cigarette, daily.
Change From Week 0 to Week 7 in Functional System Score - Cerebellar	-0.5714 units on a scale Standard Deviation 0.7868	-0.7500 units on a scale Standard Deviation 0.7071	0.0 units on a scale Standard Deviation 1.2792

SECONDARY outcome

Timeframe: Week 0, Week 3

Population: Only 28 subjects completed the study through the Wk 7 visit; 2 subjects who discontinued early (AE and withdraw by subject) were active at the Wk 3 visit and were included in the Wk 3 analysis; 28 total subjects had FS Sensory assessments at both the Week 0 and Week 3 study visits and were able to be analyzed for this outcome measure.

The EDSS is a method of quantifying disability in MS patients and monitoring changes in the level of disability over time. The EDSS quantifies disability in 7 functional systems (FS): visual, brainstem, pyramidal, cerebellar, sensory, bowel and bladder, and cerebral, and includes a measure of ambulation. Neurostatus version 10/2002 was used for this study. The FS Sensory score is determined by a 7-point scale, with 0 being the lowest (normal) and 6 being the highest (sensation essentially lost below the head). Higher values indicate more impaired function. The change was calculated by taking the Week 3 score and subtracting the Week 0 score. A negative result indicates an improvement in function and correlates to a better outcome.

Outcome measures

Measure	1) Inhaled Cannabis n=6 Participants Inhaled cannabis is compared to oral placebo. Inhaled Cannabis: 20 people will be enrolled in this arm of the study and will receive study drug for 7 weeks. Subjects in this arm of the study will be instructed to take their oral medication (placebo for this group) two and a half hours prior to the inhaled medication. Subjects will take two pills and smoke one cannabis cigarette, daily.	2) Oral THC n=11 Participants Inhaled placebo is compared to oral THC. Oral THC: 20 people will be enrolled in this arm of the study and will receive study drug for 7 weeks. Subjects in this arm of the study will be instructed to take their oral medication (two 5mg dronabinol tablets) two and a half hours prior to the inhaled medication (placebo for this group). Subjects will take two pills and smoke one cigarette, daily.	3) Placebo n=11 Participants Inhaled placebo is compared to oral placebo. Placebo: 20 people will be enrolled in this arm of the study and will receive study drug for 7 weeks. Subjects in this arm of the study will be instructed to take their oral medication (placebo) two and a half hours prior to the inhaled medication (placebo). Subjects will take two pills and smoke one cigarette, daily.
Change From Week 0 to Week 3 in Functional System Score - Sensory	-0.1667 units on a scale Standard Deviation 0.7528	0.0 units on a scale Standard Deviation 0.7746	-0.1818 units on a scale Standard Deviation 1.3280

SECONDARY outcome

Timeframe: Week 0, Week 7

Population: Only 28 subjects completed the study through the Wk 7 visit; Of these 28 subjects, only 27 subjects had FS Sensory assessments at both the Week 0 and Week 7 study visits and were able to be analyzed for this outcome measure.

The EDSS is a method of quantifying disability in MS patients and monitoring changes in the level of disability over time. The EDSS quantifies disability in 7 functional systems (FS): visual, brainstem, pyramidal, cerebellar, sensory, bowel and bladder, and cerebral, and includes a measure of ambulation. Neurostatus version 10/2002 was used for this study. The FS Sensory score is determined by a 7-point scale, with 0 being the lowest (normal) and 6 being the highest (sensation essentially lost below the head). Higher values indicate more impaired function. The change was calculated by taking the Week 7 score and subtracting the Week 0 score. A negative result indicates an improvement in function and correlates to a better outcome.

Outcome measures

Measure	1) Inhaled Cannabis n=7 Participants Inhaled cannabis is compared to oral placebo. Inhaled Cannabis: 20 people will be enrolled in this arm of the study and will receive study drug for 7 weeks. Subjects in this arm of the study will be instructed to take their oral medication (placebo for this group) two and a half hours prior to the inhaled medication. Subjects will take two pills and smoke one cannabis cigarette, daily.	2) Oral THC n=8 Participants Inhaled placebo is compared to oral THC. Oral THC: 20 people will be enrolled in this arm of the study and will receive study drug for 7 weeks. Subjects in this arm of the study will be instructed to take their oral medication (two 5mg dronabinol tablets) two and a half hours prior to the inhaled medication (placebo for this group). Subjects will take two pills and smoke one cigarette, daily.	3) Placebo n=12 Participants Inhaled placebo is compared to oral placebo. Placebo: 20 people will be enrolled in this arm of the study and will receive study drug for 7 weeks. Subjects in this arm of the study will be instructed to take their oral medication (placebo) two and a half hours prior to the inhaled medication (placebo). Subjects will take two pills and smoke one cigarette, daily.
Change From Week 0 to Week 7 in Functional System Score - Sensory	0.0 units on a scale Standard Deviation 0.8165	-0.1250 units on a scale Standard Deviation 1.4577	-0.3333 units on a scale Standard Deviation 1.8749

SECONDARY outcome

Timeframe: Week 0, Week 3

Population: Only 28 subjects completed the study through the Wk 7 visit; 2 subjects who discontinued early (AE and withdraw by subject) were active at the Wk 3 visit and were included in the Wk 3 analysis; 28 total subjects had FS Bowel \& Bladder assessments at both the Week 0 and Week 3 study visits and were able to be analyzed for this outcome measure.

The EDSS is a method of quantifying disability in MS patients and monitoring changes in the level of disability over time. The EDSS quantifies disability in 7 functional systems (FS): visual, brainstem, pyramidal, cerebellar, sensory, bowel and bladder, and cerebral, and includes a measure of ambulation. Neurostatus version 10/2002 was used for this study. The FS Bowel and Bladder score is determined by a 7-point scale, with 0 being the lowest (normal) and 6 being the highest (loss of bowel and bladder function). Higher values indicate more impaired function. The change was calculated by taking the Week 3 score and subtracting the Week 0 score. A negative result indicates an improvement in function and correlates to a better outcome.

Outcome measures

Measure	1) Inhaled Cannabis n=6 Participants Inhaled cannabis is compared to oral placebo. Inhaled Cannabis: 20 people will be enrolled in this arm of the study and will receive study drug for 7 weeks. Subjects in this arm of the study will be instructed to take their oral medication (placebo for this group) two and a half hours prior to the inhaled medication. Subjects will take two pills and smoke one cannabis cigarette, daily.	2) Oral THC n=11 Participants Inhaled placebo is compared to oral THC. Oral THC: 20 people will be enrolled in this arm of the study and will receive study drug for 7 weeks. Subjects in this arm of the study will be instructed to take their oral medication (two 5mg dronabinol tablets) two and a half hours prior to the inhaled medication (placebo for this group). Subjects will take two pills and smoke one cigarette, daily.	3) Placebo n=11 Participants Inhaled placebo is compared to oral placebo. Placebo: 20 people will be enrolled in this arm of the study and will receive study drug for 7 weeks. Subjects in this arm of the study will be instructed to take their oral medication (placebo) two and a half hours prior to the inhaled medication (placebo). Subjects will take two pills and smoke one cigarette, daily.
Change From Week 0 to Week 3 in Functional System Score - Bowel and Bladder	-0.1667 units on a scale Standard Deviation 0.4082	0.0 units on a scale Standard Deviation 1.0954	-0.2727 units on a scale Standard Deviation 1.1909

SECONDARY outcome

Timeframe: Week 0, Week 7

Population: Only 28 subjects completed the study through the Wk 7 visit; Of these 28 subjects, only 27 subjects had FS Bowel \& Bladder assessments at both the Week 0 and Week 7 study visits and were able to be analyzed for this outcome measure.

The EDSS is a method of quantifying disability in MS patients and monitoring changes in the level of disability over time. The EDSS quantifies disability in 7 functional systems (FS): visual, brainstem, pyramidal, cerebellar, sensory, bowel and bladder, and cerebral, and includes a measure of ambulation. Neurostatus version 10/2002 was used for this study. The FS Bowel and Bladder score is determined by a 7-point scale, with 0 being the lowest (normal) and 6 being the highest (loss of bowel and bladder function). Higher values indicate more impaired function. The change was calculated by taking the Week 7 score and subtracting the Week 0 score. A negative result indicates an improvement in function and correlates to a better outcome.

Outcome measures

Measure	1) Inhaled Cannabis n=7 Participants Inhaled cannabis is compared to oral placebo. Inhaled Cannabis: 20 people will be enrolled in this arm of the study and will receive study drug for 7 weeks. Subjects in this arm of the study will be instructed to take their oral medication (placebo for this group) two and a half hours prior to the inhaled medication. Subjects will take two pills and smoke one cannabis cigarette, daily.	2) Oral THC n=8 Participants Inhaled placebo is compared to oral THC. Oral THC: 20 people will be enrolled in this arm of the study and will receive study drug for 7 weeks. Subjects in this arm of the study will be instructed to take their oral medication (two 5mg dronabinol tablets) two and a half hours prior to the inhaled medication (placebo for this group). Subjects will take two pills and smoke one cigarette, daily.	3) Placebo n=12 Participants Inhaled placebo is compared to oral placebo. Placebo: 20 people will be enrolled in this arm of the study and will receive study drug for 7 weeks. Subjects in this arm of the study will be instructed to take their oral medication (placebo) two and a half hours prior to the inhaled medication (placebo). Subjects will take two pills and smoke one cigarette, daily.
Change From Week 0 to Week 7 in Functional System Score - Bowel and Bladder	-0.5714 units on a scale Standard Deviation 1.1339	0.2500 units on a scale Standard Deviation 1.2817	-0.3333 units on a scale Standard Deviation 1.1547

SECONDARY outcome

Timeframe: Week 0, Week 3

Population: Only 28 subjects completed the study through the Wk 7 visit; 2 subjects who discontinued early (AE and withdraw by subject) were active at the Wk 3 visit and were included in the Wk 3 analysis; 28 total subjects had FS Cerebral assessments at both the Week 0 and Week 3 study visits and were able to be analyzed for this outcome measure.

The EDSS is a method of quantifying disability in MS patients and monitoring changes in the level of disability over time. The EDSS quantifies disability in 7 functional systems (FS): visual, brainstem, pyramidal, cerebellar, sensory, bowel and bladder, and cerebral, and includes a measure of ambulation. Neurostatus version 10/2002 was used for this study. The FS Cerebral score is determined by a 6-point scale, with 0 being the lowest (normal) and 5 being the highest (dementia). Higher values indicate more impaired function. The change was calculated by taking the Week 3 score and subtracting the Week 0 score. A negative result indicates an improvement in function and correlates to a better outcome. Fatigue did not contribute to this FS score or the EDSS total score.

Outcome measures

Measure	1) Inhaled Cannabis n=6 Participants Inhaled cannabis is compared to oral placebo. Inhaled Cannabis: 20 people will be enrolled in this arm of the study and will receive study drug for 7 weeks. Subjects in this arm of the study will be instructed to take their oral medication (placebo for this group) two and a half hours prior to the inhaled medication. Subjects will take two pills and smoke one cannabis cigarette, daily.	2) Oral THC n=11 Participants Inhaled placebo is compared to oral THC. Oral THC: 20 people will be enrolled in this arm of the study and will receive study drug for 7 weeks. Subjects in this arm of the study will be instructed to take their oral medication (two 5mg dronabinol tablets) two and a half hours prior to the inhaled medication (placebo for this group). Subjects will take two pills and smoke one cigarette, daily.	3) Placebo n=11 Participants Inhaled placebo is compared to oral placebo. Placebo: 20 people will be enrolled in this arm of the study and will receive study drug for 7 weeks. Subjects in this arm of the study will be instructed to take their oral medication (placebo) two and a half hours prior to the inhaled medication (placebo). Subjects will take two pills and smoke one cigarette, daily.
Change From Week 0 to Week 3 in Functional System Score - Cerebral	0.50 units on a scale Standard Deviation 0.8367	0.0 units on a scale Standard Deviation 0.6325	-0.3636 units on a scale Standard Deviation 0.8090

SECONDARY outcome

Timeframe: Week 0, Week 7

Population: Only 28 subjects completed the study through the Wk 7 visit; Of these 28 subjects, only 27 subjects had FS Cerebral assessments at both the Week 0 and Week 7 study visits and were able to be analyzed for this outcome measure.

The EDSS is a method of quantifying disability in MS patients and monitoring changes in the level of disability over time. The EDSS quantifies disability in 7 functional systems (FS): visual, brainstem, pyramidal, cerebellar, sensory, bowel and bladder, and cerebral, and includes a measure of ambulation. Neurostatus version 10/2002 was used for this study. The FS Cerebral score is determined by a 6-point scale, with 0 being the lowest (normal) and 5 being the highest (dementia). Higher values indicate more impaired function. The change was calculated by taking the Week 7 score and subtracting the Week 0 score. A negative result indicates an improvement in function and correlates to a better outcome. Fatigue did not contribute to this FS score or the EDSS total score.

Outcome measures

Measure	1) Inhaled Cannabis n=7 Participants Inhaled cannabis is compared to oral placebo. Inhaled Cannabis: 20 people will be enrolled in this arm of the study and will receive study drug for 7 weeks. Subjects in this arm of the study will be instructed to take their oral medication (placebo for this group) two and a half hours prior to the inhaled medication. Subjects will take two pills and smoke one cannabis cigarette, daily.	2) Oral THC n=8 Participants Inhaled placebo is compared to oral THC. Oral THC: 20 people will be enrolled in this arm of the study and will receive study drug for 7 weeks. Subjects in this arm of the study will be instructed to take their oral medication (two 5mg dronabinol tablets) two and a half hours prior to the inhaled medication (placebo for this group). Subjects will take two pills and smoke one cigarette, daily.	3) Placebo n=12 Participants Inhaled placebo is compared to oral placebo. Placebo: 20 people will be enrolled in this arm of the study and will receive study drug for 7 weeks. Subjects in this arm of the study will be instructed to take their oral medication (placebo) two and a half hours prior to the inhaled medication (placebo). Subjects will take two pills and smoke one cigarette, daily.
Change From Week 0 to Week 7 in Functional System Score - Cerebral	0.4286 units on a scale Standard Deviation 0.5345	0.0 units on a scale Standard Deviation 0.5345	-0.2500 units on a scale Standard Deviation 0.8660

SECONDARY outcome

Timeframe: Week 0, Week 3

Population: Only 28 subjects completed the study through the Wk 7 visit; 2 subjects who discontinued early (AE and withdraw by subject) were active at the Wk 3 visit and were included in the Wk 3 analysis; 28 total subjects had completed \& scored EDSS assessments at both the Week 0 and Week 3 study visits and were able to be analyzed for this outcome measure.

The EDSS is a method of quantifying disability in MS patients and monitoring changes in the level of disability over time. The EDSS quantifies disability in 7 functional systems (FS): visual, brainstem, pyramidal, cerebellar, sensory, bowel and bladder, and cerebral, and includes a measure of ambulation. Neurostatus version 10/2002 was used for this study. The total EDSS score ranges from 0 to 10, in 0.5 unit increments. A score of 0 is the lowest (normal neurological exam) and 10 is the highest (death due to MS). Higher values indicate more impaired function. The change was calculated by taking the Week 3 score and subtracting the Week 0 score. A negative result indicates an improvement in function and correlates to a better outcome.

Outcome measures

Measure	1) Inhaled Cannabis n=6 Participants Inhaled cannabis is compared to oral placebo. Inhaled Cannabis: 20 people will be enrolled in this arm of the study and will receive study drug for 7 weeks. Subjects in this arm of the study will be instructed to take their oral medication (placebo for this group) two and a half hours prior to the inhaled medication. Subjects will take two pills and smoke one cannabis cigarette, daily.	2) Oral THC n=11 Participants Inhaled placebo is compared to oral THC. Oral THC: 20 people will be enrolled in this arm of the study and will receive study drug for 7 weeks. Subjects in this arm of the study will be instructed to take their oral medication (two 5mg dronabinol tablets) two and a half hours prior to the inhaled medication (placebo for this group). Subjects will take two pills and smoke one cigarette, daily.	3) Placebo n=11 Participants Inhaled placebo is compared to oral placebo. Placebo: 20 people will be enrolled in this arm of the study and will receive study drug for 7 weeks. Subjects in this arm of the study will be instructed to take their oral medication (placebo) two and a half hours prior to the inhaled medication (placebo). Subjects will take two pills and smoke one cigarette, daily.
Change From Week 0 to Week 3 in Expanded Disability Status Score (EDSS)	-0.0833 units on a scale Standard Deviation 0.2041	0.0909 units on a scale Standard Deviation 0.3015	-0.2727 units on a scale Standard Deviation 0.5641

SECONDARY outcome

Timeframe: Week 0, Week 7

Population: Only 28 subjects completed the study through the Wk 7 visit; Of these 28 subjects, only 27 subjects had completed \& scored EDSS assessments at both the Week 0 and Week 7 study visits and were able to be analyzed for this outcome measure.

The EDSS is a method of quantifying disability in MS patients and monitoring changes in the level of disability over time. The EDSS quantifies disability in 7 functional systems (FS): visual, brainstem, pyramidal, cerebellar, sensory, bowel and bladder, and cerebral, and includes a measure of ambulation. Neurostatus version 10/2002 was used for this study. The total EDSS score ranges from 0 to 10, in 0.5 unit increments. A score of 0 is the lowest (normal neurological exam) and 10 is the highest (death due to MS). Higher values indicate more impaired function. The change was calculated by taking the Week 7 score and subtracting the Week 0 score. A negative result indicates an improvement in function and correlates to a better outcome.

Outcome measures

Measure	1) Inhaled Cannabis n=7 Participants Inhaled cannabis is compared to oral placebo. Inhaled Cannabis: 20 people will be enrolled in this arm of the study and will receive study drug for 7 weeks. Subjects in this arm of the study will be instructed to take their oral medication (placebo for this group) two and a half hours prior to the inhaled medication. Subjects will take two pills and smoke one cannabis cigarette, daily.	2) Oral THC n=8 Participants Inhaled placebo is compared to oral THC. Oral THC: 20 people will be enrolled in this arm of the study and will receive study drug for 7 weeks. Subjects in this arm of the study will be instructed to take their oral medication (two 5mg dronabinol tablets) two and a half hours prior to the inhaled medication (placebo for this group). Subjects will take two pills and smoke one cigarette, daily.	3) Placebo n=12 Participants Inhaled placebo is compared to oral placebo. Placebo: 20 people will be enrolled in this arm of the study and will receive study drug for 7 weeks. Subjects in this arm of the study will be instructed to take their oral medication (placebo) two and a half hours prior to the inhaled medication (placebo). Subjects will take two pills and smoke one cigarette, daily.
Change From Week 0 to Week 7 in Expanded Disability Status Score (EDSS)	0.0714 units on a scale Standard Deviation 0.3450	0.0 units on a scale Standard Deviation 0.0	-0.2083 units on a scale Standard Deviation 0.6557

SECONDARY outcome

Timeframe: Week 0, Week 3

Population: Only 28 subjects completed the study through the Wk 7 visit; 2 subjects who discontinued early (AE \& withdraw by subject) were active at the Wk 3 visit and were included in the Wk 3 analysis; 21 total subjects completed all SF-36 physical component questions at both the Wk 0 and Wk 3 study visits and were analyzed for this outcome measure.

The SF-36 is a 36-item scale developed as a generic health status measure. It is a part of the MS Quality of Life Inventory. It can be reported as 2 summary scales - the Physical and Mental components. The scale is measured from 0 -100. The scale is set up so that a higher score indicates better health. The change was calculated by taking the Week 3 score and subtracting the Week 0 score. A positive result indicates an improvement in health status and correlates to a better outcome. A negative result indicates a decline in health and correlates to a worse outcome.

Outcome measures

Measure	1) Inhaled Cannabis n=7 Participants Inhaled cannabis is compared to oral placebo. Inhaled Cannabis: 20 people will be enrolled in this arm of the study and will receive study drug for 7 weeks. Subjects in this arm of the study will be instructed to take their oral medication (placebo for this group) two and a half hours prior to the inhaled medication. Subjects will take two pills and smoke one cannabis cigarette, daily.	2) Oral THC n=7 Participants Inhaled placebo is compared to oral THC. Oral THC: 20 people will be enrolled in this arm of the study and will receive study drug for 7 weeks. Subjects in this arm of the study will be instructed to take their oral medication (two 5mg dronabinol tablets) two and a half hours prior to the inhaled medication (placebo for this group). Subjects will take two pills and smoke one cigarette, daily.	3) Placebo n=7 Participants Inhaled placebo is compared to oral placebo. Placebo: 20 people will be enrolled in this arm of the study and will receive study drug for 7 weeks. Subjects in this arm of the study will be instructed to take their oral medication (placebo) two and a half hours prior to the inhaled medication (placebo). Subjects will take two pills and smoke one cigarette, daily.
Change From Week 0 to Week 3 in MS Quality of Life Inventory (MSQLI) - SF-36 Physical Component Score	2.5734 units on a scale Standard Deviation 9.1669	4.3401 units on a scale Standard Deviation 9.9668	1.2656 units on a scale Standard Deviation 6.3093

SECONDARY outcome

Timeframe: Week 0, Week 7

Population: Only 28 subjects completed the study through the Wk 7 visit; Of these 28 subjects, only 23 subjects completed all SF-36 physical component questions at both the Week 0 and Week 7 study visits and were able to be analyzed for this outcome measure.

The SF-36 is a 36-item scale developed as a generic health status measure. It is a part of the MS Quality of Life Inventory. It can be reported as 2 summary scales - the Physical and Mental components. The scale is measured from 0 -100. The scale is set up so that a higher score indicates better health. The change was calculated by taking the Week 7 score and subtracting the Week 0 score. A positive result indicates an improvement in health status and correlates to a better outcome. A negative result indicates a decline in health and correlates to a worse outcome.

Outcome measures

Measure	1) Inhaled Cannabis n=6 Participants Inhaled cannabis is compared to oral placebo. Inhaled Cannabis: 20 people will be enrolled in this arm of the study and will receive study drug for 7 weeks. Subjects in this arm of the study will be instructed to take their oral medication (placebo for this group) two and a half hours prior to the inhaled medication. Subjects will take two pills and smoke one cannabis cigarette, daily.	2) Oral THC n=7 Participants Inhaled placebo is compared to oral THC. Oral THC: 20 people will be enrolled in this arm of the study and will receive study drug for 7 weeks. Subjects in this arm of the study will be instructed to take their oral medication (two 5mg dronabinol tablets) two and a half hours prior to the inhaled medication (placebo for this group). Subjects will take two pills and smoke one cigarette, daily.	3) Placebo n=10 Participants Inhaled placebo is compared to oral placebo. Placebo: 20 people will be enrolled in this arm of the study and will receive study drug for 7 weeks. Subjects in this arm of the study will be instructed to take their oral medication (placebo) two and a half hours prior to the inhaled medication (placebo). Subjects will take two pills and smoke one cigarette, daily.
Change From Week 0 to Week 7 in MS Quality of Life Inventory (MSQLI) - SF-36 Physical Component Score	-0.8695 units on a scale Standard Deviation 5.7636	1.0957 units on a scale Standard Deviation 7.9274	-0.8803 units on a scale Standard Deviation 7.4724

SECONDARY outcome

Timeframe: Week 0, Week 3

Population: Only 28 subjects completed the study through the Wk 7 visit; 2 subjects who discontinued early (AE \& withdraw by subject) were active at the Wk 3 visit and were included in the Wk 3 analysis; 21 total subjects completed all SF-36 mental component questions at both the Wk 0 and Wk 3 study visits and were analyzed for this outcome measure.

The SF-36 is a 36-item scale developed as a generic health status measure. It is a part of the MS Quality of Life Inventory. It can be reported as 2 summary scales - the Physical and Mental components. The scale is measured from 0 -100. The scale is set up so that a higher score indicates better health. The change was calculated by taking the Week 3 score and subtracting the Week 0. A positive result indicates an improvement in mental health status and correlates to a better outcome. A negative result indicates a decline in mental health and correlates to a worse outcome.

Outcome measures

Measure	1) Inhaled Cannabis n=7 Participants Inhaled cannabis is compared to oral placebo. Inhaled Cannabis: 20 people will be enrolled in this arm of the study and will receive study drug for 7 weeks. Subjects in this arm of the study will be instructed to take their oral medication (placebo for this group) two and a half hours prior to the inhaled medication. Subjects will take two pills and smoke one cannabis cigarette, daily.	2) Oral THC n=7 Participants Inhaled placebo is compared to oral THC. Oral THC: 20 people will be enrolled in this arm of the study and will receive study drug for 7 weeks. Subjects in this arm of the study will be instructed to take their oral medication (two 5mg dronabinol tablets) two and a half hours prior to the inhaled medication (placebo for this group). Subjects will take two pills and smoke one cigarette, daily.	3) Placebo n=7 Participants Inhaled placebo is compared to oral placebo. Placebo: 20 people will be enrolled in this arm of the study and will receive study drug for 7 weeks. Subjects in this arm of the study will be instructed to take their oral medication (placebo) two and a half hours prior to the inhaled medication (placebo). Subjects will take two pills and smoke one cigarette, daily.
Change From Week 0 to Week 3 in MS Quality of Life Inventory (MSQLI) - SF-36 Mental Component Score	0.7606 units on a scale Standard Deviation 13.7458	-4.3820 units on a scale Standard Deviation 9.6916	2.9471 units on a scale Standard Deviation 6.8578

SECONDARY outcome

Timeframe: Week 0, Week 7

Population: Only 28 subjects completed the study through the Wk 7 visit; Of these 28 subjects, only 23 subjects completed all SF-36 mental component questions at both the Week 0 and Week 7 study visits and were able to be analyzed for this outcome measure.

The SF-36 is a 36-item scale developed as a generic health status measure. It is a part of the MS Quality of Life Inventory. It can be reported as 2 summary scales - the Physical and Mental components. The scale is measured from 0 -100. The scale is set up so that a higher score indicates better health. The change was calculated by taking the Week 3 score and subtracting the Week 0. A positive result indicates an improvement in mental health status and correlates to a better outcome. A negative result indicates a decline in mental health and correlates to a worse outcome.

Outcome measures

Measure	1) Inhaled Cannabis n=6 Participants Inhaled cannabis is compared to oral placebo. Inhaled Cannabis: 20 people will be enrolled in this arm of the study and will receive study drug for 7 weeks. Subjects in this arm of the study will be instructed to take their oral medication (placebo for this group) two and a half hours prior to the inhaled medication. Subjects will take two pills and smoke one cannabis cigarette, daily.	2) Oral THC n=7 Participants Inhaled placebo is compared to oral THC. Oral THC: 20 people will be enrolled in this arm of the study and will receive study drug for 7 weeks. Subjects in this arm of the study will be instructed to take their oral medication (two 5mg dronabinol tablets) two and a half hours prior to the inhaled medication (placebo for this group). Subjects will take two pills and smoke one cigarette, daily.	3) Placebo n=10 Participants Inhaled placebo is compared to oral placebo. Placebo: 20 people will be enrolled in this arm of the study and will receive study drug for 7 weeks. Subjects in this arm of the study will be instructed to take their oral medication (placebo) two and a half hours prior to the inhaled medication (placebo). Subjects will take two pills and smoke one cigarette, daily.
Change From Week 0 to Week 7 in MS Quality of Life Inventory (MSQLI) - SF-36 Mental Component	5.7328 units on a scale Standard Deviation 12.6299	-2.0820 units on a scale Standard Deviation 13.4123	1.6035 units on a scale Standard Deviation 13.9515

SECONDARY outcome

Timeframe: Week 0, Week 3

Population: Only 28 subjects completed the study through the Wk 7 visit; 2 subjects who discontinued early (AE \& withdraw by subject) were active at the Wk 3 visit and were included in the Wk 3 analysis; 26 total subjects completed all Modified Fatigue Index questions at both the Wk 0 and Wk 3 study visits and were analyzed for this outcome measure.

The Modified Fatigue Index is a 21-item scale developed to assess the perceived impact of fatigue on daily activities. It is a part of the MS Quality of Life Inventory. The scale is measured from 0-84. The scale is set up so that a higher score indicates a greater impact of fatigue on a patient's daily activities. The change was calculated by taking the Week 3 score and subtracting the Week 0 score. A negative result indicates a decrease in the impact of fatigue on daily activities and correlates to a better outcome. A positive result indicates an increase in the impact of fatigue on daily activities and correlates to a worse outcome.

Outcome measures

Measure	1) Inhaled Cannabis n=6 Participants Inhaled cannabis is compared to oral placebo. Inhaled Cannabis: 20 people will be enrolled in this arm of the study and will receive study drug for 7 weeks. Subjects in this arm of the study will be instructed to take their oral medication (placebo for this group) two and a half hours prior to the inhaled medication. Subjects will take two pills and smoke one cannabis cigarette, daily.	2) Oral THC n=10 Participants Inhaled placebo is compared to oral THC. Oral THC: 20 people will be enrolled in this arm of the study and will receive study drug for 7 weeks. Subjects in this arm of the study will be instructed to take their oral medication (two 5mg dronabinol tablets) two and a half hours prior to the inhaled medication (placebo for this group). Subjects will take two pills and smoke one cigarette, daily.	3) Placebo n=10 Participants Inhaled placebo is compared to oral placebo. Placebo: 20 people will be enrolled in this arm of the study and will receive study drug for 7 weeks. Subjects in this arm of the study will be instructed to take their oral medication (placebo) two and a half hours prior to the inhaled medication (placebo). Subjects will take two pills and smoke one cigarette, daily.
Change From Week 0 to Week3 in MS Quality of Life Inventory (MSQLI) - Modified Fatigue Index Score	-11.3333 units on a scale Standard Deviation 10.7641	1.2000 units on a scale Standard Deviation 10.9016	-9.600 units on a scale Standard Deviation 16.5341

SECONDARY outcome

Timeframe: Week 0, Week 7

Population: Only 28 subjects completed the study through the Wk 7 visit; Of these 28 subjects, only 26 subjects completed all Modified Fatigue Index questions at both the Week 0 and Week 7 study visits and were able to be analyzed for this outcome measure.

The Modified Fatigue Index is a 21-item scale developed to assess the perceived impact of fatigue on daily activities. It is a part of the MS Quality of Life Inventory. The scale is measured from 0 - 84. The scale is set up so that a higher score indicates a greater impact of fatigue on a patient's daily activities. The change was calculated by taking the Week 7 score and subtracting the Week 0 score. A negative result indicates a decrease in the impact of fatigue on daily activities and correlates to a better outcome. A positive result indicates an increase in the impact of fatigue on daily activities and correlates to a worse outcome.

Outcome measures

Measure	1) Inhaled Cannabis n=6 Participants Inhaled cannabis is compared to oral placebo. Inhaled Cannabis: 20 people will be enrolled in this arm of the study and will receive study drug for 7 weeks. Subjects in this arm of the study will be instructed to take their oral medication (placebo for this group) two and a half hours prior to the inhaled medication. Subjects will take two pills and smoke one cannabis cigarette, daily.	2) Oral THC n=9 Participants Inhaled placebo is compared to oral THC. Oral THC: 20 people will be enrolled in this arm of the study and will receive study drug for 7 weeks. Subjects in this arm of the study will be instructed to take their oral medication (two 5mg dronabinol tablets) two and a half hours prior to the inhaled medication (placebo for this group). Subjects will take two pills and smoke one cigarette, daily.	3) Placebo n=11 Participants Inhaled placebo is compared to oral placebo. Placebo: 20 people will be enrolled in this arm of the study and will receive study drug for 7 weeks. Subjects in this arm of the study will be instructed to take their oral medication (placebo) two and a half hours prior to the inhaled medication (placebo). Subjects will take two pills and smoke one cigarette, daily.
Change From Week 0 to Week 7 in MS Quality of Life Inventory (MSQLI) - Modified Fatigue Index Score	-15.50 units on a scale Standard Deviation 11.3798	1.3333 units on a scale Standard Deviation 6.3836	-11.0909 units on a scale Standard Deviation 18.4470

SECONDARY outcome

Timeframe: Week 0, Week 3

Population: Only 28 subjects completed the study through the Wk 7 visit; 2 subjects who discontinued early (AE \& withdraw by subject) were active at the Wk 3 visit and were included in the Wk 3 analysis; 28 total subjects completed all Pain Effects scale questions at both the Wk 0 and Wk 3 study visits and were analyzed for this outcome measure.

The Pain Effects Scale is a 6-item scale developed to assess the effects of pain on behavior and mood. It is a part of the MS Quality of Life Inventory. The scale is measured from 6-30. The scale is set up so that a higher score indicates a greater impact of pain on a patient's mood and behavior. The change was calculated by taking the Week 3 score and subtracting the Week 0 score. A negative result indicates a decrease in the impact of pain on mood and behavior and correlates to a better outcome. A positive result indicates an increase in the impact of pain on mood and behavior and correlates to a worse outcome.

Outcome measures

Measure	1) Inhaled Cannabis n=7 Participants Inhaled cannabis is compared to oral placebo. Inhaled Cannabis: 20 people will be enrolled in this arm of the study and will receive study drug for 7 weeks. Subjects in this arm of the study will be instructed to take their oral medication (placebo for this group) two and a half hours prior to the inhaled medication. Subjects will take two pills and smoke one cannabis cigarette, daily.	2) Oral THC n=10 Participants Inhaled placebo is compared to oral THC. Oral THC: 20 people will be enrolled in this arm of the study and will receive study drug for 7 weeks. Subjects in this arm of the study will be instructed to take their oral medication (two 5mg dronabinol tablets) two and a half hours prior to the inhaled medication (placebo for this group). Subjects will take two pills and smoke one cigarette, daily.	3) Placebo n=11 Participants Inhaled placebo is compared to oral placebo. Placebo: 20 people will be enrolled in this arm of the study and will receive study drug for 7 weeks. Subjects in this arm of the study will be instructed to take their oral medication (placebo) two and a half hours prior to the inhaled medication (placebo). Subjects will take two pills and smoke one cigarette, daily.
Change From Week 0 to Week 3 in MS Quality of Life Inventory (MSQLI) - Pain Effects Scale Score	-1.0 units on a scale Standard Deviation 4.2032	-2.20 units on a scale Standard Deviation 5.0067	-2.5455 units on a scale Standard Deviation 5.8028

SECONDARY outcome

Timeframe: Week 0, Week 7

Population: Only 28 subjects completed the study through the Wk 7 visit; Of these 28 subjects, all 28 subjects completed all Pain Effects scale questions at both the Week 0 and Week 7 study visits and were able to be analyzed for this outcome measure.

The Pain Effects Scale is a 6-item scale developed to assess the effects of pain on behavior and mood. It is a part of the MS Quality of Life Inventory. The scale is measured from 6-30. The scale is set up so that a higher score indicates a greater impact of pain on a patient's mood and behavior. The change was calculated by taking the Week 7 score and subtracting the Week 0 score. A negative result indicates a decrease in the impact of pain on mood and behavior and correlates to a better outcome. A positive result indicates an increase in the impact of pain on mood and behavior and correlates to a worse outcome.

Outcome measures

Measure	1) Inhaled Cannabis n=7 Participants Inhaled cannabis is compared to oral placebo. Inhaled Cannabis: 20 people will be enrolled in this arm of the study and will receive study drug for 7 weeks. Subjects in this arm of the study will be instructed to take their oral medication (placebo for this group) two and a half hours prior to the inhaled medication. Subjects will take two pills and smoke one cannabis cigarette, daily.	2) Oral THC n=9 Participants Inhaled placebo is compared to oral THC. Oral THC: 20 people will be enrolled in this arm of the study and will receive study drug for 7 weeks. Subjects in this arm of the study will be instructed to take their oral medication (two 5mg dronabinol tablets) two and a half hours prior to the inhaled medication (placebo for this group). Subjects will take two pills and smoke one cigarette, daily.	3) Placebo n=12 Participants Inhaled placebo is compared to oral placebo. Placebo: 20 people will be enrolled in this arm of the study and will receive study drug for 7 weeks. Subjects in this arm of the study will be instructed to take their oral medication (placebo) two and a half hours prior to the inhaled medication (placebo). Subjects will take two pills and smoke one cigarette, daily.
Change From Week 0 to Week 7 in MS Quality of Life Inventory (MSQLI) - Pain Effects Scale Score	-2.5714 units on a scale Standard Deviation 5.9121	-2.4444 units on a scale Standard Deviation 5.2228	-2.500 units on a scale Standard Deviation 4.5627

SECONDARY outcome

Timeframe: Week 0, Week 3

Population: Only 28 subjects completed the study through the Wk 7 visit; 2 subjects who discontinued early (AE \& withdraw by subject) were active at the Wk 3 visit and were included in the Wk 3 analysis; 19 total subjects completed all Sexual Satisfaction scale questions at both the Wk 0 and Wk 3 study visits and were analyzed for this outcome measure.

The Sexual Satisfaction Scale is a 4-item scale developed to assess the impact of multiple sclerosis on sexual function and satisfaction. It is a part of the MS Quality of Life Inventory. The scale is measured from 4-24. The scale is set up so that a higher score indicates greater problems with sexual satisfaction. Subjects that answered "No" to the question, "Do you have a relationship with one primary partner", did not complete the scale. The change was calculated by taking the Week 3 score and subtracting the Week 0 score. A negative result indicates an improvement in sexual satisfaction and correlates to a better outcome. A positive result indicates a decrease in sexual satisfaction and correlates to a worse outcome.

Outcome measures

Measure	1) Inhaled Cannabis n=4 Participants Inhaled cannabis is compared to oral placebo. Inhaled Cannabis: 20 people will be enrolled in this arm of the study and will receive study drug for 7 weeks. Subjects in this arm of the study will be instructed to take their oral medication (placebo for this group) two and a half hours prior to the inhaled medication. Subjects will take two pills and smoke one cannabis cigarette, daily.	2) Oral THC n=6 Participants Inhaled placebo is compared to oral THC. Oral THC: 20 people will be enrolled in this arm of the study and will receive study drug for 7 weeks. Subjects in this arm of the study will be instructed to take their oral medication (two 5mg dronabinol tablets) two and a half hours prior to the inhaled medication (placebo for this group). Subjects will take two pills and smoke one cigarette, daily.	3) Placebo n=9 Participants Inhaled placebo is compared to oral placebo. Placebo: 20 people will be enrolled in this arm of the study and will receive study drug for 7 weeks. Subjects in this arm of the study will be instructed to take their oral medication (placebo) two and a half hours prior to the inhaled medication (placebo). Subjects will take two pills and smoke one cigarette, daily.
Change From Week 0 to Week 3 in MS Quality of Life Inventory (MSQLI) - Sexual Satisfaction Scale Score	-4.250 units on a scale Standard Deviation 3.5940	0.6667 units on a scale Standard Deviation 0.8165	-0.7778 units on a scale Standard Deviation 2.5386

SECONDARY outcome

Timeframe: Week 0, Week 7

Population: Only 28 subjects completed the study through the Wk 7 visit; Of these 28 subjects, only 19 subjects completed all Sexual Satisfaction scale questions at both the Week 0 and Week 7 study visits and were able to be analyzed for this outcome measure.

The Sexual Satisfaction Scale is a 4-item scale developed to assess the impact of multiple sclerosis on sexual function and satisfaction. It is a part of the MS Quality of Life Inventory. The scale is measured from 4-24. The scale is set up so that a higher score indicates greater problems with sexual satisfaction. Subjects that answered "No" to the question, "Do you have a relationship with one primary partner", did not complete the scale. The change was calculated by taking the Week 7 score and subtracting the Week 0 score. A negative result indicates an improvement in sexual satisfaction and correlates to a better outcome. A positive result indicates a decrease in sexual satisfaction and correlates to a worse outcome.

Outcome measures

Measure	1) Inhaled Cannabis n=4 Participants Inhaled cannabis is compared to oral placebo. Inhaled Cannabis: 20 people will be enrolled in this arm of the study and will receive study drug for 7 weeks. Subjects in this arm of the study will be instructed to take their oral medication (placebo for this group) two and a half hours prior to the inhaled medication. Subjects will take two pills and smoke one cannabis cigarette, daily.	2) Oral THC n=6 Participants Inhaled placebo is compared to oral THC. Oral THC: 20 people will be enrolled in this arm of the study and will receive study drug for 7 weeks. Subjects in this arm of the study will be instructed to take their oral medication (two 5mg dronabinol tablets) two and a half hours prior to the inhaled medication (placebo for this group). Subjects will take two pills and smoke one cigarette, daily.	3) Placebo n=9 Participants Inhaled placebo is compared to oral placebo. Placebo: 20 people will be enrolled in this arm of the study and will receive study drug for 7 weeks. Subjects in this arm of the study will be instructed to take their oral medication (placebo) two and a half hours prior to the inhaled medication (placebo). Subjects will take two pills and smoke one cigarette, daily.
Change From Week 0 to Week 7 in MS Quality of Life Inventory (MSQLI) - Sexual Satisfaction Scale Score	-3.750 units on a scale Standard Deviation 2.0616	0.1667 units on a scale Standard Deviation 3.1252	2.5556 units on a scale Standard Deviation 6.0438

SECONDARY outcome

Timeframe: Week 0, Week 3

Population: Only 28 subjects completed the study through the Wk 7 visit; 2 subjects who discontinued early (AE \& withdraw by subject) were active at the Wk 3 visit and were included in the Wk 3 analysis; 27 total subjects completed all Bladder Control scale questions at both the Wk 0 and Wk 3 study visits and were analyzed for this outcome measure.

The Bladder Control Scale is a 4-item scale developed to assess the impact of multiple sclerosis on bladder function. It is a part of the MS Quality of Life Inventory. The scale is measured from 0-22. The scale is set up so that a higher score indicates greater bladder control problems. The change was calculated by taking the Week 3 score and subtracting the Week 0 score. A negative result indicates an improvement in bladder control and correlates to a better outcome. A positive result indicates a decrease in bladder control and correlates to a worse outcome.

Outcome measures

Measure	1) Inhaled Cannabis n=6 Participants Inhaled cannabis is compared to oral placebo. Inhaled Cannabis: 20 people will be enrolled in this arm of the study and will receive study drug for 7 weeks. Subjects in this arm of the study will be instructed to take their oral medication (placebo for this group) two and a half hours prior to the inhaled medication. Subjects will take two pills and smoke one cannabis cigarette, daily.	2) Oral THC n=10 Participants Inhaled placebo is compared to oral THC. Oral THC: 20 people will be enrolled in this arm of the study and will receive study drug for 7 weeks. Subjects in this arm of the study will be instructed to take their oral medication (two 5mg dronabinol tablets) two and a half hours prior to the inhaled medication (placebo for this group). Subjects will take two pills and smoke one cigarette, daily.	3) Placebo n=11 Participants Inhaled placebo is compared to oral placebo. Placebo: 20 people will be enrolled in this arm of the study and will receive study drug for 7 weeks. Subjects in this arm of the study will be instructed to take their oral medication (placebo) two and a half hours prior to the inhaled medication (placebo). Subjects will take two pills and smoke one cigarette, daily.
Change From Week 0 to Week 3 in MS Quality of Life Inventory (MSQLI) - Bladder Control Scale Score	0.500 units on a scale Standard Deviation 2.0736	-0.700 units on a scale Standard Deviation 6.3254	-2.1818 units on a scale Standard Deviation 7.7951

SECONDARY outcome

Timeframe: Week 0, Week 7

Population: Only 28 subjects completed the study through the Wk 7 visit; Of these 28 subjects, all 28 subjects completed all Bladder Control scale questions at both the Week 0 and Week 7 study visits and were able to be analyzed for this outcome measure.

The Bladder Control Scale is a 4-item scale developed to assess the impact of multiple sclerosis on bladder function. It is a part of the MS Quality of Life Inventory. The scale is measured from 0-22. The scale is set up so that a higher score indicates greater bladder control problems. The change was calculated by taking the Week 7 score and subtracting the Week 0 score. A negative result indicates an improvement in bladder control and correlates to a better outcome. A positive result indicates a decrease in bladder control and correlates to a worse outcome.

Outcome measures

Measure	1) Inhaled Cannabis n=7 Participants Inhaled cannabis is compared to oral placebo. Inhaled Cannabis: 20 people will be enrolled in this arm of the study and will receive study drug for 7 weeks. Subjects in this arm of the study will be instructed to take their oral medication (placebo for this group) two and a half hours prior to the inhaled medication. Subjects will take two pills and smoke one cannabis cigarette, daily.	2) Oral THC n=9 Participants Inhaled placebo is compared to oral THC. Oral THC: 20 people will be enrolled in this arm of the study and will receive study drug for 7 weeks. Subjects in this arm of the study will be instructed to take their oral medication (two 5mg dronabinol tablets) two and a half hours prior to the inhaled medication (placebo for this group). Subjects will take two pills and smoke one cigarette, daily.	3) Placebo n=12 Participants Inhaled placebo is compared to oral placebo. Placebo: 20 people will be enrolled in this arm of the study and will receive study drug for 7 weeks. Subjects in this arm of the study will be instructed to take their oral medication (placebo) two and a half hours prior to the inhaled medication (placebo). Subjects will take two pills and smoke one cigarette, daily.
Change From Week 0 to Week 7 in MS Quality of Life Inventory (MSQLI) - Bladder Control Scale Score	-0.8571 units on a scale Standard Deviation 4.0999	-1.8889 units on a scale Standard Deviation 5.2068	-2.500 units on a scale Standard Deviation 6.0977

SECONDARY outcome

Timeframe: Week 0, Week 3

Population: Only 28 subjects completed the study through the Wk 7 visit; 2 subjects who discontinued early (AE \& withdraw by subject) were active at the Wk 3 visit and were included in the Wk 3 analysis; 26 total subjects completed all Bowel Control scale questions at both the Wk 0 and Wk 3 study visits and were analyzed for this outcome measure.

The Bowel Control Scale is a 5-item scale developed to assess the impact of multiple sclerosis on bowel function. It is a part of the MS Quality of Life Inventory. The scale is measured from 0-26. The scale is set up so that a higher score indicates greater bowel control problems. The change was calculated by taking the Week 3 score and subtracting the Week 0 score. A negative result indicates an improvement in bowel control and correlates to a better outcome. A positive result indicates a decrease in bowel control and correlates to a worse outcome.

Outcome measures

Measure	1) Inhaled Cannabis n=7 Participants Inhaled cannabis is compared to oral placebo. Inhaled Cannabis: 20 people will be enrolled in this arm of the study and will receive study drug for 7 weeks. Subjects in this arm of the study will be instructed to take their oral medication (placebo for this group) two and a half hours prior to the inhaled medication. Subjects will take two pills and smoke one cannabis cigarette, daily.	2) Oral THC n=10 Participants Inhaled placebo is compared to oral THC. Oral THC: 20 people will be enrolled in this arm of the study and will receive study drug for 7 weeks. Subjects in this arm of the study will be instructed to take their oral medication (two 5mg dronabinol tablets) two and a half hours prior to the inhaled medication (placebo for this group). Subjects will take two pills and smoke one cigarette, daily.	3) Placebo n=9 Participants Inhaled placebo is compared to oral placebo. Placebo: 20 people will be enrolled in this arm of the study and will receive study drug for 7 weeks. Subjects in this arm of the study will be instructed to take their oral medication (placebo) two and a half hours prior to the inhaled medication (placebo). Subjects will take two pills and smoke one cigarette, daily.
Change From Week 0 to Week 3 in MS Quality of Life Inventory (MSQLI) - Bowel Control Scale Score	-0.7143 units on a scale Standard Deviation 4.4240	-1.000 units on a scale Standard Deviation 4.8762	0.7778 units on a scale Standard Deviation 2.1667

SECONDARY outcome

Timeframe: Week 0, Week 7

Population: Only 28 subjects completed the study through the Wk 7 visit; Of these 28 subjects, only 27 subjects completed all Bowel Control scale questions at both the Week 0 and Week 7 study visits and were able to be analyzed for this outcome measure.

The Bowel Control Scale is a 5-item scale developed to assess the impact of multiple sclerosis on bowel function. It is a part of the MS Quality of Life Inventory. The scale is measured from 0-26. The scale is set up so that a higher score indicates greater bowel control problems. The change was calculated by taking the Week 7 score and subtracting the Week 0 score. A negative result indicates an improvement in bowel control and correlates to a better outcome. A positive result indicates a decrease in bowel control and correlates to a worse outcome.

Outcome measures

Measure	1) Inhaled Cannabis n=7 Participants Inhaled cannabis is compared to oral placebo. Inhaled Cannabis: 20 people will be enrolled in this arm of the study and will receive study drug for 7 weeks. Subjects in this arm of the study will be instructed to take their oral medication (placebo for this group) two and a half hours prior to the inhaled medication. Subjects will take two pills and smoke one cannabis cigarette, daily.	2) Oral THC n=9 Participants Inhaled placebo is compared to oral THC. Oral THC: 20 people will be enrolled in this arm of the study and will receive study drug for 7 weeks. Subjects in this arm of the study will be instructed to take their oral medication (two 5mg dronabinol tablets) two and a half hours prior to the inhaled medication (placebo for this group). Subjects will take two pills and smoke one cigarette, daily.	3) Placebo n=11 Participants Inhaled placebo is compared to oral placebo. Placebo: 20 people will be enrolled in this arm of the study and will receive study drug for 7 weeks. Subjects in this arm of the study will be instructed to take their oral medication (placebo) two and a half hours prior to the inhaled medication (placebo). Subjects will take two pills and smoke one cigarette, daily.
Change From Week 0 to Week 7 in MS Quality of Life Inventory (MSQLI) - Bowel Control Scale Score	-0.7143 units on a scale Standard Deviation 4.4615	0.2222 units on a scale Standard Deviation 2.7739	0.4545 units on a scale Standard Deviation 3.5599

SECONDARY outcome

Timeframe: Week 0, Week 3

Population: Only 28 subjects completed the study through the Wk 7 visit; 2 subjects who discontinued early (AE \& withdraw by subject) were active at the Wk 3 visit and were included in the Wk 3 analysis; 27 total subjects completed all Impact of Visual Impairment scale questions at both the Wk 0 and Wk 3 study visits and were analyzed for this outcome measure.

The Impact of Visual Impairment Scale is a 5-item scale developed to assess the extent to which activities dependent on vision are affected by MS-related visual problems. It is a part of the MS Quality of Life Inventory. The scale is measured from 0-15. The scale is set up so that a higher score indicates greater impact of visual problems on daily activities. The change was calculated by taking the Week 3 score and subtracting the Week 0 score. A negative result indicates a decrease in the impact of visual problems on daily activities and correlates to a better outcome. A positive result indicates an increase in the impact of visual problems on daily activities and correlates to a worse outcome.

Outcome measures

Measure	1) Inhaled Cannabis n=7 Participants Inhaled cannabis is compared to oral placebo. Inhaled Cannabis: 20 people will be enrolled in this arm of the study and will receive study drug for 7 weeks. Subjects in this arm of the study will be instructed to take their oral medication (placebo for this group) two and a half hours prior to the inhaled medication. Subjects will take two pills and smoke one cannabis cigarette, daily.	2) Oral THC n=9 Participants Inhaled placebo is compared to oral THC. Oral THC: 20 people will be enrolled in this arm of the study and will receive study drug for 7 weeks. Subjects in this arm of the study will be instructed to take their oral medication (two 5mg dronabinol tablets) two and a half hours prior to the inhaled medication (placebo for this group). Subjects will take two pills and smoke one cigarette, daily.	3) Placebo n=11 Participants Inhaled placebo is compared to oral placebo. Placebo: 20 people will be enrolled in this arm of the study and will receive study drug for 7 weeks. Subjects in this arm of the study will be instructed to take their oral medication (placebo) two and a half hours prior to the inhaled medication (placebo). Subjects will take two pills and smoke one cigarette, daily.
Change From Week 0 to Week 3 in MS Quality of Life Inventory (MSQLI) - Impact of Visual Impairment Scale Score	-0.2857 units on a scale Standard Deviation 1.2536	0.5556 units on a scale Standard Deviation 1.6667	0.00 units on a scale Standard Deviation 2.5690

SECONDARY outcome

Timeframe: Week 0, Week 7

Population: Only 28 subjects completed the study through the Wk 7 visit; Of these 28 subjects, only 27 subjects completed all Impact of Visual Impairment scale questions at both the Week 0 and Week 7 study visits and were able to be analyzed for this outcome measure.

The Impact of Visual Impairment Scale is a 5-item scale developed to assess the extent to which activities dependent on vision are affected by MS-related visual problems. It is a part of the MS Quality of Life Inventory. The scale is measured from 0-15. The scale is set up so that a higher score indicates greater impact of visual problems on daily activities. The change was calculated by taking the Week 7 score and subtracting the Week 0 score. A negative result indicates a decrease in the impact of visual problems on daily activities and correlates to a better outcome. A positive result indicates an increase in the impact of visual problems on daily activities and correlates to a worse outcome.

Outcome measures

Measure	1) Inhaled Cannabis n=7 Participants Inhaled cannabis is compared to oral placebo. Inhaled Cannabis: 20 people will be enrolled in this arm of the study and will receive study drug for 7 weeks. Subjects in this arm of the study will be instructed to take their oral medication (placebo for this group) two and a half hours prior to the inhaled medication. Subjects will take two pills and smoke one cannabis cigarette, daily.	2) Oral THC n=8 Participants Inhaled placebo is compared to oral THC. Oral THC: 20 people will be enrolled in this arm of the study and will receive study drug for 7 weeks. Subjects in this arm of the study will be instructed to take their oral medication (two 5mg dronabinol tablets) two and a half hours prior to the inhaled medication (placebo for this group). Subjects will take two pills and smoke one cigarette, daily.	3) Placebo n=12 Participants Inhaled placebo is compared to oral placebo. Placebo: 20 people will be enrolled in this arm of the study and will receive study drug for 7 weeks. Subjects in this arm of the study will be instructed to take their oral medication (placebo) two and a half hours prior to the inhaled medication (placebo). Subjects will take two pills and smoke one cigarette, daily.
Change From Week 0 to Week 7 in MS Quality of Life Inventory (MSQLI) - Impact of Visual Impairment Scale Score	0.5714 units on a scale Standard Deviation 0.7868	0.2500 units on a scale Standard Deviation 1.9821	-0.7500 units on a scale Standard Deviation 1.7645

SECONDARY outcome

Timeframe: Week 0, Week 3

Population: Only 28 subjects completed the study through the Wk 7 visit; 2 subjects who discontinued early (AE \& withdraw by subject) were active at the Wk 3 visit and were included in the Wk 3 analysis; 27 total subjects completed all Perceived Deficits scale questions at both the Wk 0 and Wk 3 study visits and were analyzed for this outcome measure.

The Perceived Deficits Scale is a 20-item scale developed to assess the patient's perceived cognitive deficits. It is composed of four 5-item subscales: Attention/Concentration, Retrospective Memory, Prospective Memory, and Planning/Organization. It is a part of the MS Quality of Life Inventory. The total score is measured from 0-80. The scale is set up so that a higher score indicates greater perceived cognitive impairment. The change was calculated by taking the Week 3 score and subtracting the Week 0 score. A negative result indicates a decrease in the perception of cognitive impairment. A positive result indicates an increase in the perception of cognitive impairment. Since patient perceptions of cognitive impairment may not correlate with objective measures of cognitive impairment, the results should be interpreted with caution.

Outcome measures

Measure	1) Inhaled Cannabis n=7 Participants Inhaled cannabis is compared to oral placebo. Inhaled Cannabis: 20 people will be enrolled in this arm of the study and will receive study drug for 7 weeks. Subjects in this arm of the study will be instructed to take their oral medication (placebo for this group) two and a half hours prior to the inhaled medication. Subjects will take two pills and smoke one cannabis cigarette, daily.	2) Oral THC n=10 Participants Inhaled placebo is compared to oral THC. Oral THC: 20 people will be enrolled in this arm of the study and will receive study drug for 7 weeks. Subjects in this arm of the study will be instructed to take their oral medication (two 5mg dronabinol tablets) two and a half hours prior to the inhaled medication (placebo for this group). Subjects will take two pills and smoke one cigarette, daily.	3) Placebo n=10 Participants Inhaled placebo is compared to oral placebo. Placebo: 20 people will be enrolled in this arm of the study and will receive study drug for 7 weeks. Subjects in this arm of the study will be instructed to take their oral medication (placebo) two and a half hours prior to the inhaled medication (placebo). Subjects will take two pills and smoke one cigarette, daily.
Change From Week 0 to Week 3 in MS Quality of Life Inventory (MSQLI) - Perceived Deficits Scale Score	-3.2857 units on a scale Standard Deviation 10.7659	3.000 units on a scale Standard Deviation 6.5828	-6.600 units on a scale Standard Deviation 14.4929

SECONDARY outcome

Timeframe: Week 0, Week 7

Population: Only 28 subjects completed the study through the Wk 7 visit; Of these 28 subjects, only 26 subjects completed all Perceived Deficits scale questions at both the Week 0 and Week 7 study visits and were able to be analyzed for this outcome measure.

The Perceived Deficits Scale is a 20-item scale developed to assess the patient's perceived cognitive deficits. It is composed of four 5-item subscales: Attention/Concentration, Retrospective Memory, Prospective Memory, and Planning/Organization. It is a part of the MS Quality of Life Inventory. The total score is measured from 0-80. The scale is set up so that a higher score indicates greater perceived cognitive impairment. The change was calculated by taking the Week 7 score and subtracting the Week 0 score. A negative result indicates a decrease in the perception of cognitive impairment. A positive result indicates an increase in the perception of cognitive impairment. Since patient perceptions of cognitive impairment may not correlate with objective measures of cognitive impairment, the results should be interpreted with caution.

Outcome measures

Measure	1) Inhaled Cannabis n=7 Participants Inhaled cannabis is compared to oral placebo. Inhaled Cannabis: 20 people will be enrolled in this arm of the study and will receive study drug for 7 weeks. Subjects in this arm of the study will be instructed to take their oral medication (placebo for this group) two and a half hours prior to the inhaled medication. Subjects will take two pills and smoke one cannabis cigarette, daily.	2) Oral THC n=8 Participants Inhaled placebo is compared to oral THC. Oral THC: 20 people will be enrolled in this arm of the study and will receive study drug for 7 weeks. Subjects in this arm of the study will be instructed to take their oral medication (two 5mg dronabinol tablets) two and a half hours prior to the inhaled medication (placebo for this group). Subjects will take two pills and smoke one cigarette, daily.	3) Placebo n=11 Participants Inhaled placebo is compared to oral placebo. Placebo: 20 people will be enrolled in this arm of the study and will receive study drug for 7 weeks. Subjects in this arm of the study will be instructed to take their oral medication (placebo) two and a half hours prior to the inhaled medication (placebo). Subjects will take two pills and smoke one cigarette, daily.
Change From Week 0 to Week 7 in MS Quality of Life Inventory (MSQLI) - Perceived Deficits Scale Score	-4.8571 units on a scale Standard Deviation 13.0822	4.3750 units on a scale Standard Deviation 5.4494	-2.0909 units on a scale Standard Deviation 10.2903

SECONDARY outcome

Timeframe: Week 0, Week 3

Population: Only 28 subjects completed the study through Wk 7; 2 subjects who discontinued early (AE \& withdraw by subject) were active at Wk 3 and were included in the Wk 3 analysis; 14 subjects completed all MHI questions at both the Wk 0 and Wk 3 and were analyzed for this outcome measure. The MHI was added late to the study beginning with subject 22 of 42

The Mental Health Inventory (MHI) is an 18-item scale developed as a measure of overall emotional functioning. It is a part of the MS Quality of Life Inventory. The total score is measured from 0-100. The scale is set up so that a higher score indicates better mental health. The change was calculated by taking the Week 3 score and subtracting the Week 0 score. A positive result indicates an improvement in mental health and correlates to a better outcome. A negative result indicates decrease in mental health and correlates to a worse outcome.

Outcome measures

Measure	1) Inhaled Cannabis n=3 Participants Inhaled cannabis is compared to oral placebo. Inhaled Cannabis: 20 people will be enrolled in this arm of the study and will receive study drug for 7 weeks. Subjects in this arm of the study will be instructed to take their oral medication (placebo for this group) two and a half hours prior to the inhaled medication. Subjects will take two pills and smoke one cannabis cigarette, daily.	2) Oral THC n=6 Participants Inhaled placebo is compared to oral THC. Oral THC: 20 people will be enrolled in this arm of the study and will receive study drug for 7 weeks. Subjects in this arm of the study will be instructed to take their oral medication (two 5mg dronabinol tablets) two and a half hours prior to the inhaled medication (placebo for this group). Subjects will take two pills and smoke one cigarette, daily.	3) Placebo n=5 Participants Inhaled placebo is compared to oral placebo. Placebo: 20 people will be enrolled in this arm of the study and will receive study drug for 7 weeks. Subjects in this arm of the study will be instructed to take their oral medication (placebo) two and a half hours prior to the inhaled medication (placebo). Subjects will take two pills and smoke one cigarette, daily.
Change From Week 0 to Week 3 in MS Quality of Life Inventory (MSQLI) - Mental Health Inventory Scale Score	-14.8148 units on a scale Standard Deviation 22.8882	4.6296 units on a scale Standard Deviation 19.5305	4.6667 units on a scale Standard Deviation 6.3050

SECONDARY outcome

Timeframe: Week 0, Week 7

Population: Only 28 subjects completed the study through the Wk 7 visit; Of these 28 subjects, only 14 subjects completed all Mental Health Inventory questions at both the Week 0 and Week 7 study visits and were able to be analyzed for this outcome measure. The Mental Health Inventory was added late to the study beginning with subject 22 of 42

The Mental Health Inventory (MHI) is an 18-item scale developed as a measure of overall emotional functioning. It is a part of the MS Quality of Life Inventory. The total score is measured from 0-100. The scale is set up so that a higher score indicates better mental health. The change was calculated by taking the Week 7 score and subtracting the Week 0 score. A positive result indicates an improvement in mental health and correlates to a better outcome. A negative result indicates decrease in mental health and correlates to a worse outcome.

Outcome measures

Measure	1) Inhaled Cannabis n=3 Participants Inhaled cannabis is compared to oral placebo. Inhaled Cannabis: 20 people will be enrolled in this arm of the study and will receive study drug for 7 weeks. Subjects in this arm of the study will be instructed to take their oral medication (placebo for this group) two and a half hours prior to the inhaled medication. Subjects will take two pills and smoke one cannabis cigarette, daily.	2) Oral THC n=5 Participants Inhaled placebo is compared to oral THC. Oral THC: 20 people will be enrolled in this arm of the study and will receive study drug for 7 weeks. Subjects in this arm of the study will be instructed to take their oral medication (two 5mg dronabinol tablets) two and a half hours prior to the inhaled medication (placebo for this group). Subjects will take two pills and smoke one cigarette, daily.	3) Placebo n=6 Participants Inhaled placebo is compared to oral placebo. Placebo: 20 people will be enrolled in this arm of the study and will receive study drug for 7 weeks. Subjects in this arm of the study will be instructed to take their oral medication (placebo) two and a half hours prior to the inhaled medication (placebo). Subjects will take two pills and smoke one cigarette, daily.
Change From Week 0 to Week 7 in MS Quality of Life Inventory (MSQLI) - Mental Health Inventory Scale Score	-8.8889 units on a scale Standard Deviation 20.3973	-1.1111 units on a scale Standard Deviation 4.4444	-8.7037 units on a scale Standard Deviation 23.9487

SECONDARY outcome

Timeframe: Week 0, Week 3

Population: Only 28 subjects completed the study through the Wk 7 visit; 2 subjects who discontinued early (AE \& withdraw by subject) were active at the Wk 3 visit and were included in the Wk 3 analysis; 26 total subjects completed all Modified Social Support scale questions at both the Wk 0 and Wk 3 study visits and were analyzed for this outcome measure.

The Modified Social Support Scale is an 18-item scale developed as a measure of perceived social support. It is a part of the MS Quality of Life Inventory. The total score is measured from 0-100. The scale is set up so that a higher score indicates greater perceived support. The change was calculated by taking the Week 3 score and subtracting the Week 0 score. A positive result indicates an improvement in perceived support and correlates to a better outcome. A negative result indicates a decrease in perceived support and correlates to a worse outcome.

Outcome measures

Measure	1) Inhaled Cannabis n=7 Participants Inhaled cannabis is compared to oral placebo. Inhaled Cannabis: 20 people will be enrolled in this arm of the study and will receive study drug for 7 weeks. Subjects in this arm of the study will be instructed to take their oral medication (placebo for this group) two and a half hours prior to the inhaled medication. Subjects will take two pills and smoke one cannabis cigarette, daily.	2) Oral THC n=9 Participants Inhaled placebo is compared to oral THC. Oral THC: 20 people will be enrolled in this arm of the study and will receive study drug for 7 weeks. Subjects in this arm of the study will be instructed to take their oral medication (two 5mg dronabinol tablets) two and a half hours prior to the inhaled medication (placebo for this group). Subjects will take two pills and smoke one cigarette, daily.	3) Placebo n=10 Participants Inhaled placebo is compared to oral placebo. Placebo: 20 people will be enrolled in this arm of the study and will receive study drug for 7 weeks. Subjects in this arm of the study will be instructed to take their oral medication (placebo) two and a half hours prior to the inhaled medication (placebo). Subjects will take two pills and smoke one cigarette, daily.
Change From Week 0 to Week 3 in MS Quality of Life Inventory (MSQLI) - Modified Social Support Scale Score	-6.3988 units on a scale Standard Deviation 19.0288	0.2604 units on a scale Standard Deviation 19.1539	7.1875 units on a scale Standard Deviation 16.6011

SECONDARY outcome

Timeframe: Week 0, Week 7

Population: Only 28 subjects completed the study through the Wk 7 visit; Of these 28 subjects, only 26 subjects completed all Modified Social Support scale questions at both the Week 0 and Week 7 study visits and were able to be analyzed for this outcome measure.

The Modified Social Support Scale is an 18-item scale developed as a measure of perceived social support. It is a part of the MS Quality of Life Inventory. The total score is measured from 0-100. The scale is set up so that a higher score indicates greater perceived support. The change was calculated by taking the Week 7 score and subtracting the Week 0 score. A positive result indicates an improvement in perceived support and correlates to a better outcome. A negative result indicates a decrease in perceived support and correlates to a worse outcome.

Outcome measures

Measure	1) Inhaled Cannabis n=7 Participants Inhaled cannabis is compared to oral placebo. Inhaled Cannabis: 20 people will be enrolled in this arm of the study and will receive study drug for 7 weeks. Subjects in this arm of the study will be instructed to take their oral medication (placebo for this group) two and a half hours prior to the inhaled medication. Subjects will take two pills and smoke one cannabis cigarette, daily.	2) Oral THC n=8 Participants Inhaled placebo is compared to oral THC. Oral THC: 20 people will be enrolled in this arm of the study and will receive study drug for 7 weeks. Subjects in this arm of the study will be instructed to take their oral medication (two 5mg dronabinol tablets) two and a half hours prior to the inhaled medication (placebo for this group). Subjects will take two pills and smoke one cigarette, daily.	3) Placebo n=11 Participants Inhaled placebo is compared to oral placebo. Placebo: 20 people will be enrolled in this arm of the study and will receive study drug for 7 weeks. Subjects in this arm of the study will be instructed to take their oral medication (placebo) two and a half hours prior to the inhaled medication (placebo). Subjects will take two pills and smoke one cigarette, daily.
Change From Week 0 to Week 7 in MS Quality of Life Inventory (MSQLI) - Modified Social Support Scale Score	2.2693 units on a scale Standard Deviation 10.8750	-4.8177 units on a scale Standard Deviation 21.0544	-1.4915 units on a scale Standard Deviation 23.0668

Adverse Events

1) Inhaled Cannabis

Serious events: 3 serious events

Other events: 13 other events

Deaths: 0 deaths

2) Oral THC

Serious events: 1 serious events

Other events: 14 other events

Deaths: 0 deaths

3) Placebo

Serious events: 0 serious events

Other events: 12 other events

Deaths: 0 deaths

Serious adverse events

Measure	1) Inhaled Cannabis n=13 participants at risk Inhaled cannabis is compared to oral placebo. Inhaled Cannabis: 20 people will be enrolled in this arm of the study and will receive study drug for 7 weeks. Subjects in this arm of the study will be instructed to take their oral medication (placebo for this group) two and a half hours prior to the inhaled medication. Subjects will take two pills and smoke one cannabis cigarette, daily.	2) Oral THC n=14 participants at risk Inhaled placebo is compared to oral THC. Oral THC: 20 people will be enrolled in this arm of the study and will receive study drug for 7 weeks. Subjects in this arm of the study will be instructed to take their oral medication (two 5mg dronabinol tablets) two and a half hours prior to the inhaled medication (placebo for this group). Subjects will take two pills and smoke one cigarette, daily.	3) Placebo n=14 participants at risk Inhaled placebo is compared to oral placebo. Placebo: 20 people will be enrolled in this arm of the study and will receive study drug for 7 weeks. Subjects in this arm of the study will be instructed to take their oral medication (placebo) two and a half hours prior to the inhaled medication (placebo). Subjects will take two pills and smoke one cigarette, daily.
Cardiac disorders hypotension	7.7% 1/13 • Number of events 1 • Adverse event information was collected beginning with the initial dosing visit and continuing through the final follow up visit. Collection period was over approximately 4 months.	0.00% 0/14 • Adverse event information was collected beginning with the initial dosing visit and continuing through the final follow up visit. Collection period was over approximately 4 months.	0.00% 0/14 • Adverse event information was collected beginning with the initial dosing visit and continuing through the final follow up visit. Collection period was over approximately 4 months.
Gastrointestinal disorders dehydration due to gastroenteritis	7.7% 1/13 • Number of events 1 • Adverse event information was collected beginning with the initial dosing visit and continuing through the final follow up visit. Collection period was over approximately 4 months.	0.00% 0/14 • Adverse event information was collected beginning with the initial dosing visit and continuing through the final follow up visit. Collection period was over approximately 4 months.	0.00% 0/14 • Adverse event information was collected beginning with the initial dosing visit and continuing through the final follow up visit. Collection period was over approximately 4 months.
Surgical and medical procedures planned insertion of baclofen pump	0.00% 0/13 • Adverse event information was collected beginning with the initial dosing visit and continuing through the final follow up visit. Collection period was over approximately 4 months.	7.1% 1/14 • Number of events 1 • Adverse event information was collected beginning with the initial dosing visit and continuing through the final follow up visit. Collection period was over approximately 4 months.	0.00% 0/14 • Adverse event information was collected beginning with the initial dosing visit and continuing through the final follow up visit. Collection period was over approximately 4 months.
Psychiatric disorders hypersexual thoughts	7.7% 1/13 • Number of events 1 • Adverse event information was collected beginning with the initial dosing visit and continuing through the final follow up visit. Collection period was over approximately 4 months.	0.00% 0/14 • Adverse event information was collected beginning with the initial dosing visit and continuing through the final follow up visit. Collection period was over approximately 4 months.	0.00% 0/14 • Adverse event information was collected beginning with the initial dosing visit and continuing through the final follow up visit. Collection period was over approximately 4 months.

Other adverse events

Measure	1) Inhaled Cannabis n=13 participants at risk Inhaled cannabis is compared to oral placebo. Inhaled Cannabis: 20 people will be enrolled in this arm of the study and will receive study drug for 7 weeks. Subjects in this arm of the study will be instructed to take their oral medication (placebo for this group) two and a half hours prior to the inhaled medication. Subjects will take two pills and smoke one cannabis cigarette, daily.	2) Oral THC n=14 participants at risk Inhaled placebo is compared to oral THC. Oral THC: 20 people will be enrolled in this arm of the study and will receive study drug for 7 weeks. Subjects in this arm of the study will be instructed to take their oral medication (two 5mg dronabinol tablets) two and a half hours prior to the inhaled medication (placebo for this group). Subjects will take two pills and smoke one cigarette, daily.	3) Placebo n=14 participants at risk Inhaled placebo is compared to oral placebo. Placebo: 20 people will be enrolled in this arm of the study and will receive study drug for 7 weeks. Subjects in this arm of the study will be instructed to take their oral medication (placebo) two and a half hours prior to the inhaled medication (placebo). Subjects will take two pills and smoke one cigarette, daily.
Psychiatric disorders anorexia	0.00% 0/13 • Adverse event information was collected beginning with the initial dosing visit and continuing through the final follow up visit. Collection period was over approximately 4 months.	7.1% 1/14 • Number of events 1 • Adverse event information was collected beginning with the initial dosing visit and continuing through the final follow up visit. Collection period was over approximately 4 months.	0.00% 0/14 • Adverse event information was collected beginning with the initial dosing visit and continuing through the final follow up visit. Collection period was over approximately 4 months.
Cardiac disorders pre-syncopal episodes	0.00% 0/13 • Adverse event information was collected beginning with the initial dosing visit and continuing through the final follow up visit. Collection period was over approximately 4 months.	7.1% 1/14 • Number of events 1 • Adverse event information was collected beginning with the initial dosing visit and continuing through the final follow up visit. Collection period was over approximately 4 months.	0.00% 0/14 • Adverse event information was collected beginning with the initial dosing visit and continuing through the final follow up visit. Collection period was over approximately 4 months.
Vascular disorders deep vein thrombosis	0.00% 0/13 • Adverse event information was collected beginning with the initial dosing visit and continuing through the final follow up visit. Collection period was over approximately 4 months.	7.1% 1/14 • Number of events 1 • Adverse event information was collected beginning with the initial dosing visit and continuing through the final follow up visit. Collection period was over approximately 4 months.	0.00% 0/14 • Adverse event information was collected beginning with the initial dosing visit and continuing through the final follow up visit. Collection period was over approximately 4 months.
Psychiatric disorders "drunk" feeling	0.00% 0/13 • Adverse event information was collected beginning with the initial dosing visit and continuing through the final follow up visit. Collection period was over approximately 4 months.	7.1% 1/14 • Number of events 1 • Adverse event information was collected beginning with the initial dosing visit and continuing through the final follow up visit. Collection period was over approximately 4 months.	0.00% 0/14 • Adverse event information was collected beginning with the initial dosing visit and continuing through the final follow up visit. Collection period was over approximately 4 months.
Psychiatric disorders irritability	0.00% 0/13 • Adverse event information was collected beginning with the initial dosing visit and continuing through the final follow up visit. Collection period was over approximately 4 months.	7.1% 1/14 • Number of events 1 • Adverse event information was collected beginning with the initial dosing visit and continuing through the final follow up visit. Collection period was over approximately 4 months.	0.00% 0/14 • Adverse event information was collected beginning with the initial dosing visit and continuing through the final follow up visit. Collection period was over approximately 4 months.
Infections and infestations gastritis	0.00% 0/13 • Adverse event information was collected beginning with the initial dosing visit and continuing through the final follow up visit. Collection period was over approximately 4 months.	7.1% 1/14 • Number of events 1 • Adverse event information was collected beginning with the initial dosing visit and continuing through the final follow up visit. Collection period was over approximately 4 months.	0.00% 0/14 • Adverse event information was collected beginning with the initial dosing visit and continuing through the final follow up visit. Collection period was over approximately 4 months.
Nervous system disorders increased difficulty walking	0.00% 0/13 • Adverse event information was collected beginning with the initial dosing visit and continuing through the final follow up visit. Collection period was over approximately 4 months.	7.1% 1/14 • Number of events 1 • Adverse event information was collected beginning with the initial dosing visit and continuing through the final follow up visit. Collection period was over approximately 4 months.	0.00% 0/14 • Adverse event information was collected beginning with the initial dosing visit and continuing through the final follow up visit. Collection period was over approximately 4 months.
Nervous system disorders tunnel vision	0.00% 0/13 • Adverse event information was collected beginning with the initial dosing visit and continuing through the final follow up visit. Collection period was over approximately 4 months.	7.1% 1/14 • Number of events 1 • Adverse event information was collected beginning with the initial dosing visit and continuing through the final follow up visit. Collection period was over approximately 4 months.	0.00% 0/14 • Adverse event information was collected beginning with the initial dosing visit and continuing through the final follow up visit. Collection period was over approximately 4 months.
Nervous system disorders headrush	0.00% 0/13 • Adverse event information was collected beginning with the initial dosing visit and continuing through the final follow up visit. Collection period was over approximately 4 months.	7.1% 1/14 • Number of events 1 • Adverse event information was collected beginning with the initial dosing visit and continuing through the final follow up visit. Collection period was over approximately 4 months.	0.00% 0/14 • Adverse event information was collected beginning with the initial dosing visit and continuing through the final follow up visit. Collection period was over approximately 4 months.
Musculoskeletal and connective tissue disorders hip pain	0.00% 0/13 • Adverse event information was collected beginning with the initial dosing visit and continuing through the final follow up visit. Collection period was over approximately 4 months.	21.4% 3/14 • Number of events 3 • Adverse event information was collected beginning with the initial dosing visit and continuing through the final follow up visit. Collection period was over approximately 4 months.	0.00% 0/14 • Adverse event information was collected beginning with the initial dosing visit and continuing through the final follow up visit. Collection period was over approximately 4 months.
Nervous system disorders increased appetite	0.00% 0/13 • Adverse event information was collected beginning with the initial dosing visit and continuing through the final follow up visit. Collection period was over approximately 4 months.	14.3% 2/14 • Number of events 2 • Adverse event information was collected beginning with the initial dosing visit and continuing through the final follow up visit. Collection period was over approximately 4 months.	7.1% 1/14 • Number of events 1 • Adverse event information was collected beginning with the initial dosing visit and continuing through the final follow up visit. Collection period was over approximately 4 months.
Gastrointestinal disorders heartburn	0.00% 0/13 • Adverse event information was collected beginning with the initial dosing visit and continuing through the final follow up visit. Collection period was over approximately 4 months.	7.1% 1/14 • Number of events 1 • Adverse event information was collected beginning with the initial dosing visit and continuing through the final follow up visit. Collection period was over approximately 4 months.	7.1% 1/14 • Number of events 1 • Adverse event information was collected beginning with the initial dosing visit and continuing through the final follow up visit. Collection period was over approximately 4 months.
Psychiatric disorders euphoria	76.9% 10/13 • Number of events 10 • Adverse event information was collected beginning with the initial dosing visit and continuing through the final follow up visit. Collection period was over approximately 4 months.	42.9% 6/14 • Number of events 6 • Adverse event information was collected beginning with the initial dosing visit and continuing through the final follow up visit. Collection period was over approximately 4 months.	14.3% 2/14 • Number of events 2 • Adverse event information was collected beginning with the initial dosing visit and continuing through the final follow up visit. Collection period was over approximately 4 months.
Psychiatric disorders sense of relaxation	23.1% 3/13 • Number of events 3 • Adverse event information was collected beginning with the initial dosing visit and continuing through the final follow up visit. Collection period was over approximately 4 months.	14.3% 2/14 • Number of events 2 • Adverse event information was collected beginning with the initial dosing visit and continuing through the final follow up visit. Collection period was over approximately 4 months.	14.3% 2/14 • Number of events 2 • Adverse event information was collected beginning with the initial dosing visit and continuing through the final follow up visit. Collection period was over approximately 4 months.
Gastrointestinal disorders nausea	15.4% 2/13 • Number of events 2 • Adverse event information was collected beginning with the initial dosing visit and continuing through the final follow up visit. Collection period was over approximately 4 months.	21.4% 3/14 • Number of events 3 • Adverse event information was collected beginning with the initial dosing visit and continuing through the final follow up visit. Collection period was over approximately 4 months.	7.1% 1/14 • Number of events 1 • Adverse event information was collected beginning with the initial dosing visit and continuing through the final follow up visit. Collection period was over approximately 4 months.
Cardiac disorders lightheadedness	46.2% 6/13 • Number of events 6 • Adverse event information was collected beginning with the initial dosing visit and continuing through the final follow up visit. Collection period was over approximately 4 months.	21.4% 3/14 • Number of events 3 • Adverse event information was collected beginning with the initial dosing visit and continuing through the final follow up visit. Collection period was over approximately 4 months.	0.00% 0/14 • Adverse event information was collected beginning with the initial dosing visit and continuing through the final follow up visit. Collection period was over approximately 4 months.
Nervous system disorders dizziness	15.4% 2/13 • Number of events 2 • Adverse event information was collected beginning with the initial dosing visit and continuing through the final follow up visit. Collection period was over approximately 4 months.	14.3% 2/14 • Number of events 2 • Adverse event information was collected beginning with the initial dosing visit and continuing through the final follow up visit. Collection period was over approximately 4 months.	7.1% 1/14 • Number of events 1 • Adverse event information was collected beginning with the initial dosing visit and continuing through the final follow up visit. Collection period was over approximately 4 months.
Psychiatric disorders difficulty concentrating	15.4% 2/13 • Number of events 2 • Adverse event information was collected beginning with the initial dosing visit and continuing through the final follow up visit. Collection period was over approximately 4 months.	0.00% 0/14 • Adverse event information was collected beginning with the initial dosing visit and continuing through the final follow up visit. Collection period was over approximately 4 months.	0.00% 0/14 • Adverse event information was collected beginning with the initial dosing visit and continuing through the final follow up visit. Collection period was over approximately 4 months.
Psychiatric disorders depression	23.1% 3/13 • Number of events 3 • Adverse event information was collected beginning with the initial dosing visit and continuing through the final follow up visit. Collection period was over approximately 4 months.	28.6% 4/14 • Number of events 4 • Adverse event information was collected beginning with the initial dosing visit and continuing through the final follow up visit. Collection period was over approximately 4 months.	0.00% 0/14 • Adverse event information was collected beginning with the initial dosing visit and continuing through the final follow up visit. Collection period was over approximately 4 months.
Psychiatric disorders inappropriate laughter	15.4% 2/13 • Number of events 2 • Adverse event information was collected beginning with the initial dosing visit and continuing through the final follow up visit. Collection period was over approximately 4 months.	0.00% 0/14 • Adverse event information was collected beginning with the initial dosing visit and continuing through the final follow up visit. Collection period was over approximately 4 months.	0.00% 0/14 • Adverse event information was collected beginning with the initial dosing visit and continuing through the final follow up visit. Collection period was over approximately 4 months.
Psychiatric disorders anxiety	7.7% 1/13 • Number of events 1 • Adverse event information was collected beginning with the initial dosing visit and continuing through the final follow up visit. Collection period was over approximately 4 months.	0.00% 0/14 • Adverse event information was collected beginning with the initial dosing visit and continuing through the final follow up visit. Collection period was over approximately 4 months.	0.00% 0/14 • Adverse event information was collected beginning with the initial dosing visit and continuing through the final follow up visit. Collection period was over approximately 4 months.
Nervous system disorders headache	7.7% 1/13 • Number of events 1 • Adverse event information was collected beginning with the initial dosing visit and continuing through the final follow up visit. Collection period was over approximately 4 months.	14.3% 2/14 • Number of events 2 • Adverse event information was collected beginning with the initial dosing visit and continuing through the final follow up visit. Collection period was over approximately 4 months.	0.00% 0/14 • Adverse event information was collected beginning with the initial dosing visit and continuing through the final follow up visit. Collection period was over approximately 4 months.
Infections and infestations sinusitis	7.7% 1/13 • Number of events 1 • Adverse event information was collected beginning with the initial dosing visit and continuing through the final follow up visit. Collection period was over approximately 4 months.	0.00% 0/14 • Adverse event information was collected beginning with the initial dosing visit and continuing through the final follow up visit. Collection period was over approximately 4 months.	0.00% 0/14 • Adverse event information was collected beginning with the initial dosing visit and continuing through the final follow up visit. Collection period was over approximately 4 months.
Nervous system disorders paresthesia	23.1% 3/13 • Number of events 3 • Adverse event information was collected beginning with the initial dosing visit and continuing through the final follow up visit. Collection period was over approximately 4 months.	21.4% 3/14 • Number of events 3 • Adverse event information was collected beginning with the initial dosing visit and continuing through the final follow up visit. Collection period was over approximately 4 months.	21.4% 3/14 • Number of events 3 • Adverse event information was collected beginning with the initial dosing visit and continuing through the final follow up visit. Collection period was over approximately 4 months.
Psychiatric disorders paranoia	15.4% 2/13 • Number of events 2 • Adverse event information was collected beginning with the initial dosing visit and continuing through the final follow up visit. Collection period was over approximately 4 months.	7.1% 1/14 • Number of events 1 • Adverse event information was collected beginning with the initial dosing visit and continuing through the final follow up visit. Collection period was over approximately 4 months.	0.00% 0/14 • Adverse event information was collected beginning with the initial dosing visit and continuing through the final follow up visit. Collection period was over approximately 4 months.
Gastrointestinal disorders sore throat	15.4% 2/13 • Number of events 2 • Adverse event information was collected beginning with the initial dosing visit and continuing through the final follow up visit. Collection period was over approximately 4 months.	7.1% 1/14 • Number of events 1 • Adverse event information was collected beginning with the initial dosing visit and continuing through the final follow up visit. Collection period was over approximately 4 months.	14.3% 2/14 • Number of events 2 • Adverse event information was collected beginning with the initial dosing visit and continuing through the final follow up visit. Collection period was over approximately 4 months.
Respiratory, thoracic and mediastinal disorders cough	7.7% 1/13 • Number of events 1 • Adverse event information was collected beginning with the initial dosing visit and continuing through the final follow up visit. Collection period was over approximately 4 months.	7.1% 1/14 • Number of events 1 • Adverse event information was collected beginning with the initial dosing visit and continuing through the final follow up visit. Collection period was over approximately 4 months.	7.1% 1/14 • Number of events 1 • Adverse event information was collected beginning with the initial dosing visit and continuing through the final follow up visit. Collection period was over approximately 4 months.
Gastrointestinal disorders dry mouth	15.4% 2/13 • Number of events 2 • Adverse event information was collected beginning with the initial dosing visit and continuing through the final follow up visit. Collection period was over approximately 4 months.	28.6% 4/14 • Number of events 4 • Adverse event information was collected beginning with the initial dosing visit and continuing through the final follow up visit. Collection period was over approximately 4 months.	0.00% 0/14 • Adverse event information was collected beginning with the initial dosing visit and continuing through the final follow up visit. Collection period was over approximately 4 months.
Nervous system disorders imbalance	7.7% 1/13 • Number of events 1 • Adverse event information was collected beginning with the initial dosing visit and continuing through the final follow up visit. Collection period was over approximately 4 months.	7.1% 1/14 • Number of events 1 • Adverse event information was collected beginning with the initial dosing visit and continuing through the final follow up visit. Collection period was over approximately 4 months.	14.3% 2/14 • Number of events 2 • Adverse event information was collected beginning with the initial dosing visit and continuing through the final follow up visit. Collection period was over approximately 4 months.
Nervous system disorders generalized weakness	15.4% 2/13 • Number of events 2 • Adverse event information was collected beginning with the initial dosing visit and continuing through the final follow up visit. Collection period was over approximately 4 months.	21.4% 3/14 • Number of events 3 • Adverse event information was collected beginning with the initial dosing visit and continuing through the final follow up visit. Collection period was over approximately 4 months.	7.1% 1/14 • Number of events 1 • Adverse event information was collected beginning with the initial dosing visit and continuing through the final follow up visit. Collection period was over approximately 4 months.
Nervous system disorders limb pain	7.7% 1/13 • Number of events 1 • Adverse event information was collected beginning with the initial dosing visit and continuing through the final follow up visit. Collection period was over approximately 4 months.	14.3% 2/14 • Number of events 2 • Adverse event information was collected beginning with the initial dosing visit and continuing through the final follow up visit. Collection period was over approximately 4 months.	0.00% 0/14 • Adverse event information was collected beginning with the initial dosing visit and continuing through the final follow up visit. Collection period was over approximately 4 months.
Ear and labyrinth disorders tinnitus	7.7% 1/13 • Number of events 1 • Adverse event information was collected beginning with the initial dosing visit and continuing through the final follow up visit. Collection period was over approximately 4 months.	0.00% 0/14 • Adverse event information was collected beginning with the initial dosing visit and continuing through the final follow up visit. Collection period was over approximately 4 months.	0.00% 0/14 • Adverse event information was collected beginning with the initial dosing visit and continuing through the final follow up visit. Collection period was over approximately 4 months.
Infections and infestations upper respiratory infection	7.7% 1/13 • Number of events 1 • Adverse event information was collected beginning with the initial dosing visit and continuing through the final follow up visit. Collection period was over approximately 4 months.	14.3% 2/14 • Number of events 2 • Adverse event information was collected beginning with the initial dosing visit and continuing through the final follow up visit. Collection period was over approximately 4 months.	0.00% 0/14 • Adverse event information was collected beginning with the initial dosing visit and continuing through the final follow up visit. Collection period was over approximately 4 months.
Nervous system disorders Multiple Sclerosis relapse	7.7% 1/13 • Number of events 1 • Adverse event information was collected beginning with the initial dosing visit and continuing through the final follow up visit. Collection period was over approximately 4 months.	0.00% 0/14 • Adverse event information was collected beginning with the initial dosing visit and continuing through the final follow up visit. Collection period was over approximately 4 months.	0.00% 0/14 • Adverse event information was collected beginning with the initial dosing visit and continuing through the final follow up visit. Collection period was over approximately 4 months.
Cardiac disorders hypotension	7.7% 1/13 • Number of events 1 • Adverse event information was collected beginning with the initial dosing visit and continuing through the final follow up visit. Collection period was over approximately 4 months.	14.3% 2/14 • Number of events 2 • Adverse event information was collected beginning with the initial dosing visit and continuing through the final follow up visit. Collection period was over approximately 4 months.	0.00% 0/14 • Adverse event information was collected beginning with the initial dosing visit and continuing through the final follow up visit. Collection period was over approximately 4 months.
Eye disorders blurred vision	7.7% 1/13 • Number of events 1 • Adverse event information was collected beginning with the initial dosing visit and continuing through the final follow up visit. Collection period was over approximately 4 months.	0.00% 0/14 • Adverse event information was collected beginning with the initial dosing visit and continuing through the final follow up visit. Collection period was over approximately 4 months.	0.00% 0/14 • Adverse event information was collected beginning with the initial dosing visit and continuing through the final follow up visit. Collection period was over approximately 4 months.
Nervous system disorders diaphoresis	7.7% 1/13 • Number of events 1 • Adverse event information was collected beginning with the initial dosing visit and continuing through the final follow up visit. Collection period was over approximately 4 months.	7.1% 1/14 • Number of events 1 • Adverse event information was collected beginning with the initial dosing visit and continuing through the final follow up visit. Collection period was over approximately 4 months.	0.00% 0/14 • Adverse event information was collected beginning with the initial dosing visit and continuing through the final follow up visit. Collection period was over approximately 4 months.
Cardiac disorders chest pain	7.7% 1/13 • Number of events 1 • Adverse event information was collected beginning with the initial dosing visit and continuing through the final follow up visit. Collection period was over approximately 4 months.	7.1% 1/14 • Number of events 1 • Adverse event information was collected beginning with the initial dosing visit and continuing through the final follow up visit. Collection period was over approximately 4 months.	7.1% 1/14 • Number of events 1 • Adverse event information was collected beginning with the initial dosing visit and continuing through the final follow up visit. Collection period was over approximately 4 months.
Psychiatric disorders depersonalization	7.7% 1/13 • Number of events 1 • Adverse event information was collected beginning with the initial dosing visit and continuing through the final follow up visit. Collection period was over approximately 4 months.	7.1% 1/14 • Number of events 1 • Adverse event information was collected beginning with the initial dosing visit and continuing through the final follow up visit. Collection period was over approximately 4 months.	0.00% 0/14 • Adverse event information was collected beginning with the initial dosing visit and continuing through the final follow up visit. Collection period was over approximately 4 months.
Psychiatric disorders THC dependence	7.7% 1/13 • Number of events 1 • Adverse event information was collected beginning with the initial dosing visit and continuing through the final follow up visit. Collection period was over approximately 4 months.	0.00% 0/14 • Adverse event information was collected beginning with the initial dosing visit and continuing through the final follow up visit. Collection period was over approximately 4 months.	0.00% 0/14 • Adverse event information was collected beginning with the initial dosing visit and continuing through the final follow up visit. Collection period was over approximately 4 months.
Infections and infestations gastroenteritis	7.7% 1/13 • Number of events 1 • Adverse event information was collected beginning with the initial dosing visit and continuing through the final follow up visit. Collection period was over approximately 4 months.	7.1% 1/14 • Number of events 1 • Adverse event information was collected beginning with the initial dosing visit and continuing through the final follow up visit. Collection period was over approximately 4 months.	0.00% 0/14 • Adverse event information was collected beginning with the initial dosing visit and continuing through the final follow up visit. Collection period was over approximately 4 months.
General disorders flu-like symptoms	7.7% 1/13 • Number of events 1 • Adverse event information was collected beginning with the initial dosing visit and continuing through the final follow up visit. Collection period was over approximately 4 months.	7.1% 1/14 • Number of events 1 • Adverse event information was collected beginning with the initial dosing visit and continuing through the final follow up visit. Collection period was over approximately 4 months.	0.00% 0/14 • Adverse event information was collected beginning with the initial dosing visit and continuing through the final follow up visit. Collection period was over approximately 4 months.
Eye disorders dry eyes	7.7% 1/13 • Number of events 1 • Adverse event information was collected beginning with the initial dosing visit and continuing through the final follow up visit. Collection period was over approximately 4 months.	7.1% 1/14 • Number of events 1 • Adverse event information was collected beginning with the initial dosing visit and continuing through the final follow up visit. Collection period was over approximately 4 months.	0.00% 0/14 • Adverse event information was collected beginning with the initial dosing visit and continuing through the final follow up visit. Collection period was over approximately 4 months.
Cardiac disorders palpitations	7.7% 1/13 • Number of events 1 • Adverse event information was collected beginning with the initial dosing visit and continuing through the final follow up visit. Collection period was over approximately 4 months.	7.1% 1/14 • Number of events 1 • Adverse event information was collected beginning with the initial dosing visit and continuing through the final follow up visit. Collection period was over approximately 4 months.	0.00% 0/14 • Adverse event information was collected beginning with the initial dosing visit and continuing through the final follow up visit. Collection period was over approximately 4 months.
Psychiatric disorders visual hallucinations	7.7% 1/13 • Number of events 1 • Adverse event information was collected beginning with the initial dosing visit and continuing through the final follow up visit. Collection period was over approximately 4 months.	7.1% 1/14 • Number of events 1 • Adverse event information was collected beginning with the initial dosing visit and continuing through the final follow up visit. Collection period was over approximately 4 months.	7.1% 1/14 • Number of events 1 • Adverse event information was collected beginning with the initial dosing visit and continuing through the final follow up visit. Collection period was over approximately 4 months.
Nervous system disorders insomnia	7.7% 1/13 • Number of events 1 • Adverse event information was collected beginning with the initial dosing visit and continuing through the final follow up visit. Collection period was over approximately 4 months.	14.3% 2/14 • Number of events 2 • Adverse event information was collected beginning with the initial dosing visit and continuing through the final follow up visit. Collection period was over approximately 4 months.	0.00% 0/14 • Adverse event information was collected beginning with the initial dosing visit and continuing through the final follow up visit. Collection period was over approximately 4 months.
Psychiatric disorders heightened senses	7.7% 1/13 • Number of events 1 • Adverse event information was collected beginning with the initial dosing visit and continuing through the final follow up visit. Collection period was over approximately 4 months.	0.00% 0/14 • Adverse event information was collected beginning with the initial dosing visit and continuing through the final follow up visit. Collection period was over approximately 4 months.	0.00% 0/14 • Adverse event information was collected beginning with the initial dosing visit and continuing through the final follow up visit. Collection period was over approximately 4 months.
Psychiatric disorders delusions of grandeur	7.7% 1/13 • Number of events 1 • Adverse event information was collected beginning with the initial dosing visit and continuing through the final follow up visit. Collection period was over approximately 4 months.	0.00% 0/14 • Adverse event information was collected beginning with the initial dosing visit and continuing through the final follow up visit. Collection period was over approximately 4 months.	0.00% 0/14 • Adverse event information was collected beginning with the initial dosing visit and continuing through the final follow up visit. Collection period was over approximately 4 months.
Psychiatric disorders hypersexual thoughts	7.7% 1/13 • Number of events 1 • Adverse event information was collected beginning with the initial dosing visit and continuing through the final follow up visit. Collection period was over approximately 4 months.	0.00% 0/14 • Adverse event information was collected beginning with the initial dosing visit and continuing through the final follow up visit. Collection period was over approximately 4 months.	0.00% 0/14 • Adverse event information was collected beginning with the initial dosing visit and continuing through the final follow up visit. Collection period was over approximately 4 months.
Nervous system disorders drowsiness	7.7% 1/13 • Number of events 1 • Adverse event information was collected beginning with the initial dosing visit and continuing through the final follow up visit. Collection period was over approximately 4 months.	21.4% 3/14 • Number of events 3 • Adverse event information was collected beginning with the initial dosing visit and continuing through the final follow up visit. Collection period was over approximately 4 months.	0.00% 0/14 • Adverse event information was collected beginning with the initial dosing visit and continuing through the final follow up visit. Collection period was over approximately 4 months.
Nervous system disorders lethargy	7.7% 1/13 • Number of events 1 • Adverse event information was collected beginning with the initial dosing visit and continuing through the final follow up visit. Collection period was over approximately 4 months.	0.00% 0/14 • Adverse event information was collected beginning with the initial dosing visit and continuing through the final follow up visit. Collection period was over approximately 4 months.	0.00% 0/14 • Adverse event information was collected beginning with the initial dosing visit and continuing through the final follow up visit. Collection period was over approximately 4 months.
Psychiatric disorders abnormal thinking	7.7% 1/13 • Number of events 1 • Adverse event information was collected beginning with the initial dosing visit and continuing through the final follow up visit. Collection period was over approximately 4 months.	0.00% 0/14 • Adverse event information was collected beginning with the initial dosing visit and continuing through the final follow up visit. Collection period was over approximately 4 months.	0.00% 0/14 • Adverse event information was collected beginning with the initial dosing visit and continuing through the final follow up visit. Collection period was over approximately 4 months.
Nervous system disorders slurred speech	7.7% 1/13 • Number of events 1 • Adverse event information was collected beginning with the initial dosing visit and continuing through the final follow up visit. Collection period was over approximately 4 months.	7.1% 1/14 • Number of events 1 • Adverse event information was collected beginning with the initial dosing visit and continuing through the final follow up visit. Collection period was over approximately 4 months.	0.00% 0/14 • Adverse event information was collected beginning with the initial dosing visit and continuing through the final follow up visit. Collection period was over approximately 4 months.
Nervous system disorders memory problems	7.7% 1/13 • Number of events 1 • Adverse event information was collected beginning with the initial dosing visit and continuing through the final follow up visit. Collection period was over approximately 4 months.	0.00% 0/14 • Adverse event information was collected beginning with the initial dosing visit and continuing through the final follow up visit. Collection period was over approximately 4 months.	0.00% 0/14 • Adverse event information was collected beginning with the initial dosing visit and continuing through the final follow up visit. Collection period was over approximately 4 months.
Skin and subcutaneous tissue disorders hematoma on head	7.7% 1/13 • Number of events 1 • Adverse event information was collected beginning with the initial dosing visit and continuing through the final follow up visit. Collection period was over approximately 4 months.	0.00% 0/14 • Adverse event information was collected beginning with the initial dosing visit and continuing through the final follow up visit. Collection period was over approximately 4 months.	0.00% 0/14 • Adverse event information was collected beginning with the initial dosing visit and continuing through the final follow up visit. Collection period was over approximately 4 months.
Injury, poisoning and procedural complications injury to left arm	7.7% 1/13 • Number of events 1 • Adverse event information was collected beginning with the initial dosing visit and continuing through the final follow up visit. Collection period was over approximately 4 months.	0.00% 0/14 • Adverse event information was collected beginning with the initial dosing visit and continuing through the final follow up visit. Collection period was over approximately 4 months.	0.00% 0/14 • Adverse event information was collected beginning with the initial dosing visit and continuing through the final follow up visit. Collection period was over approximately 4 months.
Musculoskeletal and connective tissue disorders neck pain	7.7% 1/13 • Number of events 1 • Adverse event information was collected beginning with the initial dosing visit and continuing through the final follow up visit. Collection period was over approximately 4 months.	0.00% 0/14 • Adverse event information was collected beginning with the initial dosing visit and continuing through the final follow up visit. Collection period was over approximately 4 months.	0.00% 0/14 • Adverse event information was collected beginning with the initial dosing visit and continuing through the final follow up visit. Collection period was over approximately 4 months.
Infections and infestations urinary tract infection	7.7% 1/13 • Number of events 1 • Adverse event information was collected beginning with the initial dosing visit and continuing through the final follow up visit. Collection period was over approximately 4 months.	0.00% 0/14 • Adverse event information was collected beginning with the initial dosing visit and continuing through the final follow up visit. Collection period was over approximately 4 months.	14.3% 2/14 • Number of events 2 • Adverse event information was collected beginning with the initial dosing visit and continuing through the final follow up visit. Collection period was over approximately 4 months.
Nervous system disorders confusion	0.00% 0/13 • Adverse event information was collected beginning with the initial dosing visit and continuing through the final follow up visit. Collection period was over approximately 4 months.	7.1% 1/14 • Number of events 1 • Adverse event information was collected beginning with the initial dosing visit and continuing through the final follow up visit. Collection period was over approximately 4 months.	0.00% 0/14 • Adverse event information was collected beginning with the initial dosing visit and continuing through the final follow up visit. Collection period was over approximately 4 months.
Nervous system disorders facial flushing	0.00% 0/13 • Adverse event information was collected beginning with the initial dosing visit and continuing through the final follow up visit. Collection period was over approximately 4 months.	14.3% 2/14 • Number of events 2 • Adverse event information was collected beginning with the initial dosing visit and continuing through the final follow up visit. Collection period was over approximately 4 months.	0.00% 0/14 • Adverse event information was collected beginning with the initial dosing visit and continuing through the final follow up visit. Collection period was over approximately 4 months.
General disorders feeling of heaviness	0.00% 0/13 • Adverse event information was collected beginning with the initial dosing visit and continuing through the final follow up visit. Collection period was over approximately 4 months.	14.3% 2/14 • Number of events 2 • Adverse event information was collected beginning with the initial dosing visit and continuing through the final follow up visit. Collection period was over approximately 4 months.	7.1% 1/14 • Number of events 1 • Adverse event information was collected beginning with the initial dosing visit and continuing through the final follow up visit. Collection period was over approximately 4 months.
Nervous system disorders sensation of cold	0.00% 0/13 • Adverse event information was collected beginning with the initial dosing visit and continuing through the final follow up visit. Collection period was over approximately 4 months.	7.1% 1/14 • Number of events 1 • Adverse event information was collected beginning with the initial dosing visit and continuing through the final follow up visit. Collection period was over approximately 4 months.	0.00% 0/14 • Adverse event information was collected beginning with the initial dosing visit and continuing through the final follow up visit. Collection period was over approximately 4 months.
Respiratory, thoracic and mediastinal disorders wheezing	0.00% 0/13 • Adverse event information was collected beginning with the initial dosing visit and continuing through the final follow up visit. Collection period was over approximately 4 months.	7.1% 1/14 • Number of events 1 • Adverse event information was collected beginning with the initial dosing visit and continuing through the final follow up visit. Collection period was over approximately 4 months.	0.00% 0/14 • Adverse event information was collected beginning with the initial dosing visit and continuing through the final follow up visit. Collection period was over approximately 4 months.
Gastrointestinal disorders constipation	0.00% 0/13 • Adverse event information was collected beginning with the initial dosing visit and continuing through the final follow up visit. Collection period was over approximately 4 months.	7.1% 1/14 • Number of events 1 • Adverse event information was collected beginning with the initial dosing visit and continuing through the final follow up visit. Collection period was over approximately 4 months.	0.00% 0/14 • Adverse event information was collected beginning with the initial dosing visit and continuing through the final follow up visit. Collection period was over approximately 4 months.
Cardiac disorders decrease in blood pressure	0.00% 0/13 • Adverse event information was collected beginning with the initial dosing visit and continuing through the final follow up visit. Collection period was over approximately 4 months.	7.1% 1/14 • Number of events 1 • Adverse event information was collected beginning with the initial dosing visit and continuing through the final follow up visit. Collection period was over approximately 4 months.	0.00% 0/14 • Adverse event information was collected beginning with the initial dosing visit and continuing through the final follow up visit. Collection period was over approximately 4 months.
Gastrointestinal disorders itchy throat	0.00% 0/13 • Adverse event information was collected beginning with the initial dosing visit and continuing through the final follow up visit. Collection period was over approximately 4 months.	7.1% 1/14 • Number of events 1 • Adverse event information was collected beginning with the initial dosing visit and continuing through the final follow up visit. Collection period was over approximately 4 months.	0.00% 0/14 • Adverse event information was collected beginning with the initial dosing visit and continuing through the final follow up visit. Collection period was over approximately 4 months.
Psychiatric disorders loquacious	0.00% 0/13 • Adverse event information was collected beginning with the initial dosing visit and continuing through the final follow up visit. Collection period was over approximately 4 months.	14.3% 2/14 • Number of events 2 • Adverse event information was collected beginning with the initial dosing visit and continuing through the final follow up visit. Collection period was over approximately 4 months.	0.00% 0/14 • Adverse event information was collected beginning with the initial dosing visit and continuing through the final follow up visit. Collection period was over approximately 4 months.
Gastrointestinal disorders vomiting	0.00% 0/13 • Adverse event information was collected beginning with the initial dosing visit and continuing through the final follow up visit. Collection period was over approximately 4 months.	7.1% 1/14 • Number of events 1 • Adverse event information was collected beginning with the initial dosing visit and continuing through the final follow up visit. Collection period was over approximately 4 months.	0.00% 0/14 • Adverse event information was collected beginning with the initial dosing visit and continuing through the final follow up visit. Collection period was over approximately 4 months.
Infections and infestations influenza	0.00% 0/13 • Adverse event information was collected beginning with the initial dosing visit and continuing through the final follow up visit. Collection period was over approximately 4 months.	7.1% 1/14 • Number of events 1 • Adverse event information was collected beginning with the initial dosing visit and continuing through the final follow up visit. Collection period was over approximately 4 months.	7.1% 1/14 • Number of events 1 • Adverse event information was collected beginning with the initial dosing visit and continuing through the final follow up visit. Collection period was over approximately 4 months.
Injury, poisoning and procedural complications fall	0.00% 0/13 • Adverse event information was collected beginning with the initial dosing visit and continuing through the final follow up visit. Collection period was over approximately 4 months.	7.1% 1/14 • Number of events 1 • Adverse event information was collected beginning with the initial dosing visit and continuing through the final follow up visit. Collection period was over approximately 4 months.	0.00% 0/14 • Adverse event information was collected beginning with the initial dosing visit and continuing through the final follow up visit. Collection period was over approximately 4 months.
Blood and lymphatic system disorders polycythemia	0.00% 0/13 • Adverse event information was collected beginning with the initial dosing visit and continuing through the final follow up visit. Collection period was over approximately 4 months.	0.00% 0/14 • Adverse event information was collected beginning with the initial dosing visit and continuing through the final follow up visit. Collection period was over approximately 4 months.	7.1% 1/14 • Number of events 1 • Adverse event information was collected beginning with the initial dosing visit and continuing through the final follow up visit. Collection period was over approximately 4 months.
Respiratory, thoracic and mediastinal disorders pleural effusions	0.00% 0/13 • Adverse event information was collected beginning with the initial dosing visit and continuing through the final follow up visit. Collection period was over approximately 4 months.	0.00% 0/14 • Adverse event information was collected beginning with the initial dosing visit and continuing through the final follow up visit. Collection period was over approximately 4 months.	7.1% 1/14 • Number of events 1 • Adverse event information was collected beginning with the initial dosing visit and continuing through the final follow up visit. Collection period was over approximately 4 months.
Renal and urinary disorders renal mass	0.00% 0/13 • Adverse event information was collected beginning with the initial dosing visit and continuing through the final follow up visit. Collection period was over approximately 4 months.	0.00% 0/14 • Adverse event information was collected beginning with the initial dosing visit and continuing through the final follow up visit. Collection period was over approximately 4 months.	7.1% 1/14 • Number of events 1 • Adverse event information was collected beginning with the initial dosing visit and continuing through the final follow up visit. Collection period was over approximately 4 months.
Nervous system disorders increased fatigue	0.00% 0/13 • Adverse event information was collected beginning with the initial dosing visit and continuing through the final follow up visit. Collection period was over approximately 4 months.	0.00% 0/14 • Adverse event information was collected beginning with the initial dosing visit and continuing through the final follow up visit. Collection period was over approximately 4 months.	7.1% 1/14 • Number of events 1 • Adverse event information was collected beginning with the initial dosing visit and continuing through the final follow up visit. Collection period was over approximately 4 months.
Nervous system disorders involuntary movement	0.00% 0/13 • Adverse event information was collected beginning with the initial dosing visit and continuing through the final follow up visit. Collection period was over approximately 4 months.	0.00% 0/14 • Adverse event information was collected beginning with the initial dosing visit and continuing through the final follow up visit. Collection period was over approximately 4 months.	7.1% 1/14 • Number of events 1 • Adverse event information was collected beginning with the initial dosing visit and continuing through the final follow up visit. Collection period was over approximately 4 months.
Infections and infestations cellulitis	0.00% 0/13 • Adverse event information was collected beginning with the initial dosing visit and continuing through the final follow up visit. Collection period was over approximately 4 months.	0.00% 0/14 • Adverse event information was collected beginning with the initial dosing visit and continuing through the final follow up visit. Collection period was over approximately 4 months.	7.1% 1/14 • Number of events 1 • Adverse event information was collected beginning with the initial dosing visit and continuing through the final follow up visit. Collection period was over approximately 4 months.
General disorders sense of pressure in back of head	0.00% 0/13 • Adverse event information was collected beginning with the initial dosing visit and continuing through the final follow up visit. Collection period was over approximately 4 months.	0.00% 0/14 • Adverse event information was collected beginning with the initial dosing visit and continuing through the final follow up visit. Collection period was over approximately 4 months.	7.1% 1/14 • Number of events 1 • Adverse event information was collected beginning with the initial dosing visit and continuing through the final follow up visit. Collection period was over approximately 4 months.
Musculoskeletal and connective tissue disorders back strain	0.00% 0/13 • Adverse event information was collected beginning with the initial dosing visit and continuing through the final follow up visit. Collection period was over approximately 4 months.	0.00% 0/14 • Adverse event information was collected beginning with the initial dosing visit and continuing through the final follow up visit. Collection period was over approximately 4 months.	7.1% 1/14 • Number of events 1 • Adverse event information was collected beginning with the initial dosing visit and continuing through the final follow up visit. Collection period was over approximately 4 months.
Musculoskeletal and connective tissue disorders leg cramps	0.00% 0/13 • Adverse event information was collected beginning with the initial dosing visit and continuing through the final follow up visit. Collection period was over approximately 4 months.	0.00% 0/14 • Adverse event information was collected beginning with the initial dosing visit and continuing through the final follow up visit. Collection period was over approximately 4 months.	7.1% 1/14 • Number of events 1 • Adverse event information was collected beginning with the initial dosing visit and continuing through the final follow up visit. Collection period was over approximately 4 months.
Skin and subcutaneous tissue disorders pruritis	0.00% 0/13 • Adverse event information was collected beginning with the initial dosing visit and continuing through the final follow up visit. Collection period was over approximately 4 months.	0.00% 0/14 • Adverse event information was collected beginning with the initial dosing visit and continuing through the final follow up visit. Collection period was over approximately 4 months.	7.1% 1/14 • Number of events 1 • Adverse event information was collected beginning with the initial dosing visit and continuing through the final follow up visit. Collection period was over approximately 4 months.
Eye disorders eye irritation	0.00% 0/13 • Adverse event information was collected beginning with the initial dosing visit and continuing through the final follow up visit. Collection period was over approximately 4 months.	0.00% 0/14 • Adverse event information was collected beginning with the initial dosing visit and continuing through the final follow up visit. Collection period was over approximately 4 months.	7.1% 1/14 • Number of events 1 • Adverse event information was collected beginning with the initial dosing visit and continuing through the final follow up visit. Collection period was over approximately 4 months.
Gastrointestinal disorders dry throat	0.00% 0/13 • Adverse event information was collected beginning with the initial dosing visit and continuing through the final follow up visit. Collection period was over approximately 4 months.	0.00% 0/14 • Adverse event information was collected beginning with the initial dosing visit and continuing through the final follow up visit. Collection period was over approximately 4 months.	7.1% 1/14 • Number of events 1 • Adverse event information was collected beginning with the initial dosing visit and continuing through the final follow up visit. Collection period was over approximately 4 months.
Nervous system disorders increased stiffness in legs	0.00% 0/13 • Adverse event information was collected beginning with the initial dosing visit and continuing through the final follow up visit. Collection period was over approximately 4 months.	0.00% 0/14 • Adverse event information was collected beginning with the initial dosing visit and continuing through the final follow up visit. Collection period was over approximately 4 months.	7.1% 1/14 • Number of events 1 • Adverse event information was collected beginning with the initial dosing visit and continuing through the final follow up visit. Collection period was over approximately 4 months.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) benign tumor left wrist	0.00% 0/13 • Adverse event information was collected beginning with the initial dosing visit and continuing through the final follow up visit. Collection period was over approximately 4 months.	0.00% 0/14 • Adverse event information was collected beginning with the initial dosing visit and continuing through the final follow up visit. Collection period was over approximately 4 months.	7.1% 1/14 • Number of events 1 • Adverse event information was collected beginning with the initial dosing visit and continuing through the final follow up visit. Collection period was over approximately 4 months.

Additional Information

Janelle Butters, NP

UC Davis Health

Phone: 916-734-6276

Email: jbutters@ucdavis.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place