Trial Outcomes & Findings for A Drug Treatment for Cocaine Users Who Are Also on Methadone Maintenance Treatment (NCT NCT01802515)

NCT ID: NCT01802515

Last Updated: 2016-12-06

Results Overview

The number of participants completing all 8 weeks of treatment phase.

Recruitment status

TERMINATED

Study phase

Target enrollment

14 participants

Primary outcome timeframe

8 weeks of treatment

Results posted on

2016-12-06

Participant Flow

Adult male and female participants were recruited from the Greater New Haven area from September 2012 to January 2014 by word-of-mouth, flyers and from referrals from treatment centers in the local area. The study was conducted in an outpatient clinic of the West Haven VA Hospital.

After eligibility was determined, participants were randomized to placebo, 40 mg atomoxetine or 80 mg atomoxetine. The study consisted of 3 phases 1) a two-week methadone induction phase 2) an 8-week treatment phase and 3) a 4-week taper and detoxification or transfer phase.

Participant milestones

Participant milestones
Measure	Atomoxetine, Low Dose 1 capsule containing 40mg of atomoxetine by mouth everyday for 8 weeks followed by 1 week of daily placebo capsules. Atomoxetine, low dose: The effects of 40mg low dose atomoxetine will be compared to placebo and to the 80mg atomoxetine high dose.	Atomoxetine, High Dose One capsule containing 80mg of atomoxetine by mouth everyday for 8 weeks, followed by 1 week of daily 40mg atomoxetine capsules Atomoxetine, high dose: The effects of 80mg of high dose atomoxetine will be compared to placebo and to 40mg atomoxetine low dose.	Placebo (Sugar Pill) 1 placebo capsule by mouth everyday for 8 weeks of treatment invention followed by one week of placebo capsule during study medication taper. Placebo: The effects of placebo will be compared to the parallel groups of Atomoxetine high (80mg) dose and Atomoxetine low (40mg) dose.
Overall Study STARTED	5	5	4
Overall Study COMPLETED	2	5	4
Overall Study NOT COMPLETED	3	0	0

Reasons for withdrawal

Reasons for withdrawal
Measure	Atomoxetine, Low Dose 1 capsule containing 40mg of atomoxetine by mouth everyday for 8 weeks followed by 1 week of daily placebo capsules. Atomoxetine, low dose: The effects of 40mg low dose atomoxetine will be compared to placebo and to the 80mg atomoxetine high dose.	Atomoxetine, High Dose One capsule containing 80mg of atomoxetine by mouth everyday for 8 weeks, followed by 1 week of daily 40mg atomoxetine capsules Atomoxetine, high dose: The effects of 80mg of high dose atomoxetine will be compared to placebo and to 40mg atomoxetine low dose.	Placebo (Sugar Pill) 1 placebo capsule by mouth everyday for 8 weeks of treatment invention followed by one week of placebo capsule during study medication taper. Placebo: The effects of placebo will be compared to the parallel groups of Atomoxetine high (80mg) dose and Atomoxetine low (40mg) dose.
Overall Study Withdrawal by Subject	3	0	0

Baseline Characteristics

A Drug Treatment for Cocaine Users Who Are Also on Methadone Maintenance Treatment

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Atomoxetine, Low Dose n=5 Participants 1 capsule containing 40mg of atomoxetine by mouth everyday for 8 weeks followed by 1 week of daily placebo capsules. Atomoxetine, low dose: The effects of 40mg low dose atomoxetine will be compared to placebo and to the 80mg atomoxetine high dose.	Atomoxetine, High Dose n=5 Participants One capsule containing 80mg of atomoxetine by mouth everyday for 8 weeks, followed by 1 week of daily 40mg atomoxetine capsules Atomoxetine, high dose: The effects of 80mg of high dose atomoxetine will be compared to placebo and to 40mg atomoxetine low dose.	Placebo (Sugar Pill) n=4 Participants 1 placebo capsule by mouth everyday for 8 weeks of treatment invention followed by one week of placebo capsule during study medication taper. Placebo: The effects of placebo will be compared to the parallel groups of Atomoxetine high (80mg) dose and Atomoxetine low (40mg) dose.	Total n=14 Participants Total of all reporting groups
Age, Continuous	36.2 years STANDARD_DEVIATION 8.0 • n=5 Participants	47.6 years STANDARD_DEVIATION 5.63 • n=7 Participants	43.6 years STANDARD_DEVIATION 0.95 • n=5 Participants	42.3 years STANDARD_DEVIATION 7.4 • n=4 Participants
Sex: Female, Male Female	4 Participants n=5 Participants	2 Participants n=7 Participants	1 Participants n=5 Participants	7 Participants n=4 Participants
Sex: Female, Male Male	1 Participants n=5 Participants	3 Participants n=7 Participants	3 Participants n=5 Participants	7 Participants n=4 Participants
Region of Enrollment United States	5 participants n=5 Participants	5 participants n=7 Participants	4 participants n=5 Participants	14 participants n=4 Participants

PRIMARY outcome

Timeframe: 8 weeks of treatment

Population: Descriptive statistics were calculated for all enrolled subjects. A full statistical analysis was not performed due to study termination.

The number of participants completing all 8 weeks of treatment phase.

Outcome measures

Outcome measures
Measure	Atomoxetine, Low Dose n=5 Participants 1 capsule containing 40mg of atomoxetine by mouth everyday for 8 weeks followed by 1 week of daily placebo capsules. Atomoxetine, low dose: The effects of 40mg low dose atomoxetine will be compared to placebo and to the 80mg atomoxetine high dose.	Atomoxetine, High Dose n=5 Participants One capsule containing 80mg of atomoxetine by mouth everyday for 8 weeks, followed by 1 week of daily 40mg atomoxetine capsules Atomoxetine, high dose: The effects of 80mg of high dose atomoxetine will be compared to placebo and to 40mg atomoxetine low dose.	Placebo (Sugar Pill) n=4 Participants 1 placebo capsule by mouth everyday for 8 weeks of treatment invention followed by one week of placebo capsule during study medication taper. Placebo: The effects of placebo will be compared to the parallel groups of Atomoxetine high (80mg) dose and Atomoxetine low (40mg) dose.
Treatment Retention	2 participants	5 participants	4 participants

SECONDARY outcome

Timeframe: 8 weeks of treatment

Population: Descriptive statistics were calculated for all enrolled subjects. A full statistical analysis was not performed due to study termination.

Center for Epidemiological Studies-Depression. The CES-D is a 20-item self-report measure of depressive symptoms. Each of the 20 items can yield a score from 0 to 3 for a maximum total CES-D score of 60. Larger values represent more severe symptoms. It is a validated instrument with a score of 16 or more indicating clinically significant depression. The CES-D change score was computed as (total baseline CES-D score - total CES-D score at end of study).

Outcome measures

Outcome measures
Measure	Atomoxetine, Low Dose n=2 Participants 1 capsule containing 40mg of atomoxetine by mouth everyday for 8 weeks followed by 1 week of daily placebo capsules. Atomoxetine, low dose: The effects of 40mg low dose atomoxetine will be compared to placebo and to the 80mg atomoxetine high dose.	Atomoxetine, High Dose n=5 Participants One capsule containing 80mg of atomoxetine by mouth everyday for 8 weeks, followed by 1 week of daily 40mg atomoxetine capsules Atomoxetine, high dose: The effects of 80mg of high dose atomoxetine will be compared to placebo and to 40mg atomoxetine low dose.	Placebo (Sugar Pill) n=4 Participants 1 placebo capsule by mouth everyday for 8 weeks of treatment invention followed by one week of placebo capsule during study medication taper. Placebo: The effects of placebo will be compared to the parallel groups of Atomoxetine high (80mg) dose and Atomoxetine low (40mg) dose.
Change Score in the Center for Epidemiological Studies-Depression (CES-D) Scale	-2.2 units on a scale Standard Deviation 5.2	-2.2 units on a scale Standard Deviation 9.1	-3.3 units on a scale Standard Deviation 11.2

Adverse Events

Atomoxetine, Low Dose

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Atomoxetine, High Dose

Serious events: 0 serious events

Other events: 4 other events

Deaths: 0 deaths

Placebo (Sugar Pill)

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Additional Information

Dr. Mehmet Sofuoglu, Principal Investigator

Yale University

Phone: 203 937-4809

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Measure	Atomoxetine, Low Dose n=5 participants at risk 1 capsule containing 40mg of atomoxetine by mouth everyday for 8 weeks followed by 1 week of daily placebo capsules. Atomoxetine, low dose: The effects of 40mg low dose atomoxetine will be compared to placebo and to the 80mg atomoxetine high dose.	Atomoxetine, High Dose n=5 participants at risk One capsule containing 80mg of atomoxetine by mouth everyday for 8 weeks, followed by 1 week of daily 40mg atomoxetine capsules Atomoxetine, high dose: The effects of 80mg of high dose atomoxetine will be compared to placebo and to 40mg atomoxetine low dose.	Placebo (Sugar Pill) n=4 participants at risk 1 placebo capsule by mouth everyday for 8 weeks of treatment invention followed by one week of placebo capsule during study medication taper. Placebo: The effects of placebo will be compared to the parallel groups of Atomoxetine high (80mg) dose and Atomoxetine low (40mg) dose.
Nervous system disorders insomnia	20.0% 1/5 • Number of events 3 • Adverse events were collected once per week on all enrolled subjects for the 8 weeks of the treatment phase. The assessment of adverse events utilized the Brief Symptom Inventory (BSI), an instrument that consists of 77 items.	0.00% 0/5 • Adverse events were collected once per week on all enrolled subjects for the 8 weeks of the treatment phase. The assessment of adverse events utilized the Brief Symptom Inventory (BSI), an instrument that consists of 77 items.	0.00% 0/4 • Adverse events were collected once per week on all enrolled subjects for the 8 weeks of the treatment phase. The assessment of adverse events utilized the Brief Symptom Inventory (BSI), an instrument that consists of 77 items.
Reproductive system and breast disorders cramps	20.0% 1/5 • Number of events 8 • Adverse events were collected once per week on all enrolled subjects for the 8 weeks of the treatment phase. The assessment of adverse events utilized the Brief Symptom Inventory (BSI), an instrument that consists of 77 items.	0.00% 0/5 • Adverse events were collected once per week on all enrolled subjects for the 8 weeks of the treatment phase. The assessment of adverse events utilized the Brief Symptom Inventory (BSI), an instrument that consists of 77 items.	0.00% 0/4 • Adverse events were collected once per week on all enrolled subjects for the 8 weeks of the treatment phase. The assessment of adverse events utilized the Brief Symptom Inventory (BSI), an instrument that consists of 77 items.
Nervous system disorders dry mouth	20.0% 1/5 • Number of events 4 • Adverse events were collected once per week on all enrolled subjects for the 8 weeks of the treatment phase. The assessment of adverse events utilized the Brief Symptom Inventory (BSI), an instrument that consists of 77 items.	40.0% 2/5 • Number of events 10 • Adverse events were collected once per week on all enrolled subjects for the 8 weeks of the treatment phase. The assessment of adverse events utilized the Brief Symptom Inventory (BSI), an instrument that consists of 77 items.	0.00% 0/4 • Adverse events were collected once per week on all enrolled subjects for the 8 weeks of the treatment phase. The assessment of adverse events utilized the Brief Symptom Inventory (BSI), an instrument that consists of 77 items.
Nervous system disorders headache	0.00% 0/5 • Adverse events were collected once per week on all enrolled subjects for the 8 weeks of the treatment phase. The assessment of adverse events utilized the Brief Symptom Inventory (BSI), an instrument that consists of 77 items.	20.0% 1/5 • Number of events 8 • Adverse events were collected once per week on all enrolled subjects for the 8 weeks of the treatment phase. The assessment of adverse events utilized the Brief Symptom Inventory (BSI), an instrument that consists of 77 items.	25.0% 1/4 • Number of events 1 • Adverse events were collected once per week on all enrolled subjects for the 8 weeks of the treatment phase. The assessment of adverse events utilized the Brief Symptom Inventory (BSI), an instrument that consists of 77 items.
Nervous system disorders dizziness	0.00% 0/5 • Adverse events were collected once per week on all enrolled subjects for the 8 weeks of the treatment phase. The assessment of adverse events utilized the Brief Symptom Inventory (BSI), an instrument that consists of 77 items.	20.0% 1/5 • Number of events 1 • Adverse events were collected once per week on all enrolled subjects for the 8 weeks of the treatment phase. The assessment of adverse events utilized the Brief Symptom Inventory (BSI), an instrument that consists of 77 items.	0.00% 0/4 • Adverse events were collected once per week on all enrolled subjects for the 8 weeks of the treatment phase. The assessment of adverse events utilized the Brief Symptom Inventory (BSI), an instrument that consists of 77 items.
Respiratory, thoracic and mediastinal disorders shortness of breath	0.00% 0/5 • Adverse events were collected once per week on all enrolled subjects for the 8 weeks of the treatment phase. The assessment of adverse events utilized the Brief Symptom Inventory (BSI), an instrument that consists of 77 items.	40.0% 2/5 • Number of events 7 • Adverse events were collected once per week on all enrolled subjects for the 8 weeks of the treatment phase. The assessment of adverse events utilized the Brief Symptom Inventory (BSI), an instrument that consists of 77 items.	0.00% 0/4 • Adverse events were collected once per week on all enrolled subjects for the 8 weeks of the treatment phase. The assessment of adverse events utilized the Brief Symptom Inventory (BSI), an instrument that consists of 77 items.
Nervous system disorders chills	0.00% 0/5 • Adverse events were collected once per week on all enrolled subjects for the 8 weeks of the treatment phase. The assessment of adverse events utilized the Brief Symptom Inventory (BSI), an instrument that consists of 77 items.	20.0% 1/5 • Number of events 3 • Adverse events were collected once per week on all enrolled subjects for the 8 weeks of the treatment phase. The assessment of adverse events utilized the Brief Symptom Inventory (BSI), an instrument that consists of 77 items.	0.00% 0/4 • Adverse events were collected once per week on all enrolled subjects for the 8 weeks of the treatment phase. The assessment of adverse events utilized the Brief Symptom Inventory (BSI), an instrument that consists of 77 items.
Gastrointestinal disorders heartburn	0.00% 0/5 • Adverse events were collected once per week on all enrolled subjects for the 8 weeks of the treatment phase. The assessment of adverse events utilized the Brief Symptom Inventory (BSI), an instrument that consists of 77 items.	20.0% 1/5 • Number of events 8 • Adverse events were collected once per week on all enrolled subjects for the 8 weeks of the treatment phase. The assessment of adverse events utilized the Brief Symptom Inventory (BSI), an instrument that consists of 77 items.	0.00% 0/4 • Adverse events were collected once per week on all enrolled subjects for the 8 weeks of the treatment phase. The assessment of adverse events utilized the Brief Symptom Inventory (BSI), an instrument that consists of 77 items.
Nervous system disorders yawning	0.00% 0/5 • Adverse events were collected once per week on all enrolled subjects for the 8 weeks of the treatment phase. The assessment of adverse events utilized the Brief Symptom Inventory (BSI), an instrument that consists of 77 items.	20.0% 1/5 • Number of events 8 • Adverse events were collected once per week on all enrolled subjects for the 8 weeks of the treatment phase. The assessment of adverse events utilized the Brief Symptom Inventory (BSI), an instrument that consists of 77 items.	0.00% 0/4 • Adverse events were collected once per week on all enrolled subjects for the 8 weeks of the treatment phase. The assessment of adverse events utilized the Brief Symptom Inventory (BSI), an instrument that consists of 77 items.
Nervous system disorders agitation	20.0% 1/5 • Number of events 3 • Adverse events were collected once per week on all enrolled subjects for the 8 weeks of the treatment phase. The assessment of adverse events utilized the Brief Symptom Inventory (BSI), an instrument that consists of 77 items.	60.0% 3/5 • Number of events 6 • Adverse events were collected once per week on all enrolled subjects for the 8 weeks of the treatment phase. The assessment of adverse events utilized the Brief Symptom Inventory (BSI), an instrument that consists of 77 items.	0.00% 0/4 • Adverse events were collected once per week on all enrolled subjects for the 8 weeks of the treatment phase. The assessment of adverse events utilized the Brief Symptom Inventory (BSI), an instrument that consists of 77 items.
Nervous system disorders depression	0.00% 0/5 • Adverse events were collected once per week on all enrolled subjects for the 8 weeks of the treatment phase. The assessment of adverse events utilized the Brief Symptom Inventory (BSI), an instrument that consists of 77 items.	60.0% 3/5 • Number of events 9 • Adverse events were collected once per week on all enrolled subjects for the 8 weeks of the treatment phase. The assessment of adverse events utilized the Brief Symptom Inventory (BSI), an instrument that consists of 77 items.	25.0% 1/4 • Number of events 5 • Adverse events were collected once per week on all enrolled subjects for the 8 weeks of the treatment phase. The assessment of adverse events utilized the Brief Symptom Inventory (BSI), an instrument that consists of 77 items.
Nervous system disorders tiredness	0.00% 0/5 • Adverse events were collected once per week on all enrolled subjects for the 8 weeks of the treatment phase. The assessment of adverse events utilized the Brief Symptom Inventory (BSI), an instrument that consists of 77 items.	60.0% 3/5 • Number of events 6 • Adverse events were collected once per week on all enrolled subjects for the 8 weeks of the treatment phase. The assessment of adverse events utilized the Brief Symptom Inventory (BSI), an instrument that consists of 77 items.	25.0% 1/4 • Number of events 4 • Adverse events were collected once per week on all enrolled subjects for the 8 weeks of the treatment phase. The assessment of adverse events utilized the Brief Symptom Inventory (BSI), an instrument that consists of 77 items.
Nervous system disorders anxiety	20.0% 1/5 • Number of events 1 • Adverse events were collected once per week on all enrolled subjects for the 8 weeks of the treatment phase. The assessment of adverse events utilized the Brief Symptom Inventory (BSI), an instrument that consists of 77 items.	40.0% 2/5 • Number of events 5 • Adverse events were collected once per week on all enrolled subjects for the 8 weeks of the treatment phase. The assessment of adverse events utilized the Brief Symptom Inventory (BSI), an instrument that consists of 77 items.	0.00% 0/4 • Adverse events were collected once per week on all enrolled subjects for the 8 weeks of the treatment phase. The assessment of adverse events utilized the Brief Symptom Inventory (BSI), an instrument that consists of 77 items.
Nervous system disorders decreased libido	0.00% 0/5 • Adverse events were collected once per week on all enrolled subjects for the 8 weeks of the treatment phase. The assessment of adverse events utilized the Brief Symptom Inventory (BSI), an instrument that consists of 77 items.	20.0% 1/5 • Number of events 8 • Adverse events were collected once per week on all enrolled subjects for the 8 weeks of the treatment phase. The assessment of adverse events utilized the Brief Symptom Inventory (BSI), an instrument that consists of 77 items.	0.00% 0/4 • Adverse events were collected once per week on all enrolled subjects for the 8 weeks of the treatment phase. The assessment of adverse events utilized the Brief Symptom Inventory (BSI), an instrument that consists of 77 items.
Gastrointestinal disorders constipation	20.0% 1/5 • Number of events 3 • Adverse events were collected once per week on all enrolled subjects for the 8 weeks of the treatment phase. The assessment of adverse events utilized the Brief Symptom Inventory (BSI), an instrument that consists of 77 items.	40.0% 2/5 • Number of events 4 • Adverse events were collected once per week on all enrolled subjects for the 8 weeks of the treatment phase. The assessment of adverse events utilized the Brief Symptom Inventory (BSI), an instrument that consists of 77 items.	0.00% 0/4 • Adverse events were collected once per week on all enrolled subjects for the 8 weeks of the treatment phase. The assessment of adverse events utilized the Brief Symptom Inventory (BSI), an instrument that consists of 77 items.
Nervous system disorders increased perspiration	0.00% 0/5 • Adverse events were collected once per week on all enrolled subjects for the 8 weeks of the treatment phase. The assessment of adverse events utilized the Brief Symptom Inventory (BSI), an instrument that consists of 77 items.	40.0% 2/5 • Number of events 3 • Adverse events were collected once per week on all enrolled subjects for the 8 weeks of the treatment phase. The assessment of adverse events utilized the Brief Symptom Inventory (BSI), an instrument that consists of 77 items.	0.00% 0/4 • Adverse events were collected once per week on all enrolled subjects for the 8 weeks of the treatment phase. The assessment of adverse events utilized the Brief Symptom Inventory (BSI), an instrument that consists of 77 items.
Nervous system disorders decreased appetite	20.0% 1/5 • Number of events 1 • Adverse events were collected once per week on all enrolled subjects for the 8 weeks of the treatment phase. The assessment of adverse events utilized the Brief Symptom Inventory (BSI), an instrument that consists of 77 items.	20.0% 1/5 • Number of events 3 • Adverse events were collected once per week on all enrolled subjects for the 8 weeks of the treatment phase. The assessment of adverse events utilized the Brief Symptom Inventory (BSI), an instrument that consists of 77 items.	0.00% 0/4 • Adverse events were collected once per week on all enrolled subjects for the 8 weeks of the treatment phase. The assessment of adverse events utilized the Brief Symptom Inventory (BSI), an instrument that consists of 77 items.
Nervous system disorders nightmares	0.00% 0/5 • Adverse events were collected once per week on all enrolled subjects for the 8 weeks of the treatment phase. The assessment of adverse events utilized the Brief Symptom Inventory (BSI), an instrument that consists of 77 items.	20.0% 1/5 • Number of events 1 • Adverse events were collected once per week on all enrolled subjects for the 8 weeks of the treatment phase. The assessment of adverse events utilized the Brief Symptom Inventory (BSI), an instrument that consists of 77 items.	25.0% 1/4 • Number of events 2 • Adverse events were collected once per week on all enrolled subjects for the 8 weeks of the treatment phase. The assessment of adverse events utilized the Brief Symptom Inventory (BSI), an instrument that consists of 77 items.
Nervous system disorders numbness	20.0% 1/5 • Number of events 2 • Adverse events were collected once per week on all enrolled subjects for the 8 weeks of the treatment phase. The assessment of adverse events utilized the Brief Symptom Inventory (BSI), an instrument that consists of 77 items.	40.0% 2/5 • Number of events 2 • Adverse events were collected once per week on all enrolled subjects for the 8 weeks of the treatment phase. The assessment of adverse events utilized the Brief Symptom Inventory (BSI), an instrument that consists of 77 items.	0.00% 0/4 • Adverse events were collected once per week on all enrolled subjects for the 8 weeks of the treatment phase. The assessment of adverse events utilized the Brief Symptom Inventory (BSI), an instrument that consists of 77 items.
Nervous system disorders decreased concentration	0.00% 0/5 • Adverse events were collected once per week on all enrolled subjects for the 8 weeks of the treatment phase. The assessment of adverse events utilized the Brief Symptom Inventory (BSI), an instrument that consists of 77 items.	0.00% 0/5 • Adverse events were collected once per week on all enrolled subjects for the 8 weeks of the treatment phase. The assessment of adverse events utilized the Brief Symptom Inventory (BSI), an instrument that consists of 77 items.	25.0% 1/4 • Number of events 2 • Adverse events were collected once per week on all enrolled subjects for the 8 weeks of the treatment phase. The assessment of adverse events utilized the Brief Symptom Inventory (BSI), an instrument that consists of 77 items.
Nervous system disorders drowsiness	0.00% 0/5 • Adverse events were collected once per week on all enrolled subjects for the 8 weeks of the treatment phase. The assessment of adverse events utilized the Brief Symptom Inventory (BSI), an instrument that consists of 77 items.	40.0% 2/5 • Number of events 10 • Adverse events were collected once per week on all enrolled subjects for the 8 weeks of the treatment phase. The assessment of adverse events utilized the Brief Symptom Inventory (BSI), an instrument that consists of 77 items.	25.0% 1/4 • Number of events 2 • Adverse events were collected once per week on all enrolled subjects for the 8 weeks of the treatment phase. The assessment of adverse events utilized the Brief Symptom Inventory (BSI), an instrument that consists of 77 items.
Nervous system disorders hallucinations	20.0% 1/5 • Number of events 2 • Adverse events were collected once per week on all enrolled subjects for the 8 weeks of the treatment phase. The assessment of adverse events utilized the Brief Symptom Inventory (BSI), an instrument that consists of 77 items.	0.00% 0/5 • Adverse events were collected once per week on all enrolled subjects for the 8 weeks of the treatment phase. The assessment of adverse events utilized the Brief Symptom Inventory (BSI), an instrument that consists of 77 items.	0.00% 0/4 • Adverse events were collected once per week on all enrolled subjects for the 8 weeks of the treatment phase. The assessment of adverse events utilized the Brief Symptom Inventory (BSI), an instrument that consists of 77 items.
Nervous system disorders tingling	0.00% 0/5 • Adverse events were collected once per week on all enrolled subjects for the 8 weeks of the treatment phase. The assessment of adverse events utilized the Brief Symptom Inventory (BSI), an instrument that consists of 77 items.	20.0% 1/5 • Number of events 3 • Adverse events were collected once per week on all enrolled subjects for the 8 weeks of the treatment phase. The assessment of adverse events utilized the Brief Symptom Inventory (BSI), an instrument that consists of 77 items.	0.00% 0/4 • Adverse events were collected once per week on all enrolled subjects for the 8 weeks of the treatment phase. The assessment of adverse events utilized the Brief Symptom Inventory (BSI), an instrument that consists of 77 items.
Nervous system disorders ataxia	0.00% 0/5 • Adverse events were collected once per week on all enrolled subjects for the 8 weeks of the treatment phase. The assessment of adverse events utilized the Brief Symptom Inventory (BSI), an instrument that consists of 77 items.	20.0% 1/5 • Number of events 1 • Adverse events were collected once per week on all enrolled subjects for the 8 weeks of the treatment phase. The assessment of adverse events utilized the Brief Symptom Inventory (BSI), an instrument that consists of 77 items.	0.00% 0/4 • Adverse events were collected once per week on all enrolled subjects for the 8 weeks of the treatment phase. The assessment of adverse events utilized the Brief Symptom Inventory (BSI), an instrument that consists of 77 items.