Trial Outcomes & Findings for Ph1 Marinol Interaction Study - Part 2 - 1 (NCT NCT00490269)

Last Updated: 2017-01-12

Results Overview

Does dronabinol (when given during smoking of a marijuana cigarette) show changes in the number of participants that experience cardiovascular effects of smoked marijuana or has any other combination side effects.

Recruitment status

COMPLETED

Study phase

PHASE1

Target enrollment

12 participants

Primary outcome timeframe

Day 9 and 10

Results posted on

2017-01-12

Participant Flow

Recruitment was from October 31, 2006 to December 5, 2007. The study was conducted at the NIDA funded clinical pharmacology unit (CPU) at Uniformed Services University for the Health Sciences (USUHS).

Volunteers meeting the maximum 28-day screening assessment period and eligibility criteria were enrolled into the Phase-1 clinical trial. The subjects had to meet the following criteria to be eligible: be non-treatment seeking, experienced marijuana users with dependence for the past year, and subjects that were in good general health.

Participant milestones

Participant milestones
Measure	Dronabinol Subjects received either 10mg of study drug or matched placebo capsules 5 times per day on non-smoking Days 4-8 at approximately 0800, 1100, 1400, 1700 and 2000 hours. On day 9, study drug (or placebo)was given only 3 times at the 1100 and 1400 hour time points. On day 10, only the first dose of study drug (or placebo) was given at 0800.	Placebo Subjects received either 10mg of study drug or matched placebo capsules 5 times per day on non-smoking Days 4-8 at approximately 0800, 1100, 1400, 1700 and 2000 hours. On day 9, study drug (or placebo)was given only 3 times at the 1100 and 1400 hour time points. On day 10, only the first dose of study drug (or placebo) was given at 0800.
Dronabinol Then Placebo STARTED	6	6
Dronabinol Then Placebo COMPLETED	6	6
Dronabinol Then Placebo NOT COMPLETED	0	0
Placebo Then Dronabinol STARTED	6	6
Placebo Then Dronabinol COMPLETED	6	6
Placebo Then Dronabinol NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Ph1 Marinol Interaction Study - Part 2 - 1

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Dronabinol n=6 Participants Subjects received either 10mg of study drug or matched placebo capsules 5 times per day on non-smoking Days 4-8 at approximately 0800, 1100, 1400, 1700 and 2000 hours. On day 9, study drug (or placebo)was given only 3 times at the 1100 and 1400 hour time points. On day 10, only the first dose of study drug (or placebo) was given at 0800.	Placebo n=6 Participants Subjects received either 10mg of study drug or matched placebo capsules 5 times per day on non-smoking Days 4-8 at approximately 0800, 1100, 1400, 1700 and 2000 hours. On day 9, study drug (or placebo)was given only 3 times at the 1100 and 1400 hour time points. On day 10, only the first dose of study drug (or placebo) was given at 0800.	Total n=12 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
Age, Categorical Between 18 and 65 years	6 Participants n=5 Participants	6 Participants n=7 Participants	12 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Continuous	27.2 years STANDARD_DEVIATION 3.6 • n=5 Participants	27.2 years STANDARD_DEVIATION 4.9 • n=7 Participants	27.2 years STANDARD_DEVIATION 4.3 • n=5 Participants
Gender Female	2 Participants n=5 Participants	1 Participants n=7 Participants	3 Participants n=5 Participants
Gender Male	4 Participants n=5 Participants	5 Participants n=7 Participants	9 Participants n=5 Participants
Region of Enrollment United States	6 participants n=5 Participants	6 participants n=7 Participants	12 participants n=5 Participants

PRIMARY outcome

Timeframe: Day 9 and 10

Outcome measures

Outcome measures
Measure	Dronabinol n=6 Participants Subjects received either 10mg of study drug or matched placebo capsules 5 times per day on non-smoking Days 4-8 at approximately 0800, 1100, 1400, 1700 and 2000 hours. On day 9, study drug (or placebo)was given only 3 times at the 1100 and 1400 hour time points. On day 10, only the first dose of study drug (or placebo) was given at 0800.	Placebo n=6 Participants Subjects received either 10mg of study drug or matched placebo capsules 5 times per day on non-smoking Days 4-8 at approximately 0800, 1100, 1400, 1700 and 2000 hours. On day 9, study drug (or placebo)was given only 3 times at the 1100 and 1400 hour time points. On day 10, only the first dose of study drug (or placebo) was given at 0800.
Number of Participants That Experience Cardiovascular Effects of Smoked Marijuana or Has Any Other Combination Side Effects.	6 participants	6 participants

Adverse Events

Dronabinol

Serious events: 1 serious events

Other events: 6 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Dronabinol n=6 participants at risk Subjects received either 10mg of study drug or matched placebo capsules 5 times per day on non-smoking Days 4-8 at approximately 0800, 1100, 1400, 1700 and 2000 hours. On day 9, study drug (or placebo)was given only 3 times at the 1100 and 1400 hour time points. On day 10, only the first dose of study drug (or placebo) was given at 0800.	Placebo n=6 participants at risk Subjects received either 10mg of study drug or matched placebo capsules 5 times per day on non-smoking Days 4-8 at approximately 0800, 1100, 1400, 1700 and 2000 hours. On day 9, study drug (or placebo)was given only 3 times at the 1100 and 1400 hour time points. On day 10, only the first dose of study drug (or placebo) was given at 0800.
Nervous system disorders Anxiety Disorder	16.7% 1/6 • Number of events 1 • Adverse events were collected starting on Day 0 through Day 12 If a subject experienced more than one adverse events (AE), it would be recorded as a separate AE.	0.00% 0/6 • Adverse events were collected starting on Day 0 through Day 12 If a subject experienced more than one adverse events (AE), it would be recorded as a separate AE.

Other adverse events

Additional Information

Dr. Lou Cantelina

Uniformed Services University for the Health Sciences

Phone: 301-295-3240

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Measure	Dronabinol n=6 participants at risk Subjects received either 10mg of study drug or matched placebo capsules 5 times per day on non-smoking Days 4-8 at approximately 0800, 1100, 1400, 1700 and 2000 hours. On day 9, study drug (or placebo)was given only 3 times at the 1100 and 1400 hour time points. On day 10, only the first dose of study drug (or placebo) was given at 0800.	Placebo n=6 participants at risk Subjects received either 10mg of study drug or matched placebo capsules 5 times per day on non-smoking Days 4-8 at approximately 0800, 1100, 1400, 1700 and 2000 hours. On day 9, study drug (or placebo)was given only 3 times at the 1100 and 1400 hour time points. On day 10, only the first dose of study drug (or placebo) was given at 0800.
Cardiac disorders Palpitations	16.7% 1/6 • Adverse events were collected starting on Day 0 through Day 12 If a subject experienced more than one adverse events (AE), it would be recorded as a separate AE.	0.00% 0/6 • Adverse events were collected starting on Day 0 through Day 12 If a subject experienced more than one adverse events (AE), it would be recorded as a separate AE.
Gastrointestinal disorders Nausea	16.7% 1/6 • Adverse events were collected starting on Day 0 through Day 12 If a subject experienced more than one adverse events (AE), it would be recorded as a separate AE.	0.00% 0/6 • Adverse events were collected starting on Day 0 through Day 12 If a subject experienced more than one adverse events (AE), it would be recorded as a separate AE.
General disorders Fatigue	16.7% 1/6 • Adverse events were collected starting on Day 0 through Day 12 If a subject experienced more than one adverse events (AE), it would be recorded as a separate AE.	0.00% 0/6 • Adverse events were collected starting on Day 0 through Day 12 If a subject experienced more than one adverse events (AE), it would be recorded as a separate AE.
General disorders Catheter site hemmorage	16.7% 1/6 • Adverse events were collected starting on Day 0 through Day 12 If a subject experienced more than one adverse events (AE), it would be recorded as a separate AE.	0.00% 0/6 • Adverse events were collected starting on Day 0 through Day 12 If a subject experienced more than one adverse events (AE), it would be recorded as a separate AE.
General disorders Catheter site adema	16.7% 1/6 • Adverse events were collected starting on Day 0 through Day 12 If a subject experienced more than one adverse events (AE), it would be recorded as a separate AE.	0.00% 0/6 • Adverse events were collected starting on Day 0 through Day 12 If a subject experienced more than one adverse events (AE), it would be recorded as a separate AE.
General disorders Injection site inflammation	16.7% 1/6 • Adverse events were collected starting on Day 0 through Day 12 If a subject experienced more than one adverse events (AE), it would be recorded as a separate AE.	0.00% 0/6 • Adverse events were collected starting on Day 0 through Day 12 If a subject experienced more than one adverse events (AE), it would be recorded as a separate AE.
Hepatobiliary disorders Transamenase Increase	16.7% 1/6 • Adverse events were collected starting on Day 0 through Day 12 If a subject experienced more than one adverse events (AE), it would be recorded as a separate AE.	0.00% 0/6 • Adverse events were collected starting on Day 0 through Day 12 If a subject experienced more than one adverse events (AE), it would be recorded as a separate AE.
Metabolism and nutrition disorders Decrease in Appetite (NOS)	16.7% 1/6 • Adverse events were collected starting on Day 0 through Day 12 If a subject experienced more than one adverse events (AE), it would be recorded as a separate AE.	0.00% 0/6 • Adverse events were collected starting on Day 0 through Day 12 If a subject experienced more than one adverse events (AE), it would be recorded as a separate AE.
Nervous system disorders Headache	16.7% 1/6 • Adverse events were collected starting on Day 0 through Day 12 If a subject experienced more than one adverse events (AE), it would be recorded as a separate AE.	0.00% 0/6 • Adverse events were collected starting on Day 0 through Day 12 If a subject experienced more than one adverse events (AE), it would be recorded as a separate AE.
Nervous system disorders Syncope	16.7% 1/6 • Adverse events were collected starting on Day 0 through Day 12 If a subject experienced more than one adverse events (AE), it would be recorded as a separate AE.	0.00% 0/6 • Adverse events were collected starting on Day 0 through Day 12 If a subject experienced more than one adverse events (AE), it would be recorded as a separate AE.
Nervous system disorders Insomnolence	16.7% 1/6 • Adverse events were collected starting on Day 0 through Day 12 If a subject experienced more than one adverse events (AE), it would be recorded as a separate AE.	0.00% 0/6 • Adverse events were collected starting on Day 0 through Day 12 If a subject experienced more than one adverse events (AE), it would be recorded as a separate AE.
Psychiatric disorders Anxiety	16.7% 1/6 • Adverse events were collected starting on Day 0 through Day 12 If a subject experienced more than one adverse events (AE), it would be recorded as a separate AE.	0.00% 0/6 • Adverse events were collected starting on Day 0 through Day 12 If a subject experienced more than one adverse events (AE), it would be recorded as a separate AE.
Psychiatric disorders Anxiety disorders and symptoms	16.7% 1/6 • Adverse events were collected starting on Day 0 through Day 12 If a subject experienced more than one adverse events (AE), it would be recorded as a separate AE.	0.00% 0/6 • Adverse events were collected starting on Day 0 through Day 12 If a subject experienced more than one adverse events (AE), it would be recorded as a separate AE.
Psychiatric disorders Irritability	16.7% 1/6 • Adverse events were collected starting on Day 0 through Day 12 If a subject experienced more than one adverse events (AE), it would be recorded as a separate AE.	0.00% 0/6 • Adverse events were collected starting on Day 0 through Day 12 If a subject experienced more than one adverse events (AE), it would be recorded as a separate AE.
Reproductive system and breast disorders Polymenorrhea	16.7% 1/6 • Adverse events were collected starting on Day 0 through Day 12 If a subject experienced more than one adverse events (AE), it would be recorded as a separate AE.	0.00% 0/6 • Adverse events were collected starting on Day 0 through Day 12 If a subject experienced more than one adverse events (AE), it would be recorded as a separate AE.
Gastrointestinal disorders Lip ulceration	0.00% 0/6 • Adverse events were collected starting on Day 0 through Day 12 If a subject experienced more than one adverse events (AE), it would be recorded as a separate AE.	16.7% 1/6 • Adverse events were collected starting on Day 0 through Day 12 If a subject experienced more than one adverse events (AE), it would be recorded as a separate AE.