Trial Outcomes & Findings for Dronabinol Treatment for Marijuana Addiction (NCT NCT00217971)

NCT ID: NCT00217971

Last Updated: 2019-04-24

Results Overview

Timeline Followback self report data was collected. This daily report was used to assess the proportion of patients abstinent during weeks 7 and 8 of the clinical trial.

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 156 participants
• Primary outcome timeframe: weeks 7 and 8
• Results posted on: 2019-04-24

Participant Flow

All participants were seeking outpatient treatment for problems related to marijuana use and were recruited by local advertising or by clinical referrals in the New York City metropolitan area. Recruitment ran from 3/05-8/09 and patients participated in the trial at a research clinic at Columbia University.

The trial included a one-week placebo lead-in phase. Individuals who were able to significantly decrease their marijuana use during the first week of the study were not randomized. Participants who reported marijuana use less than twice a week during the placebo lead-in phase were considered placebo responders.

Participant milestones

Measure	Dronabinol Dronabinol: 20mg bid for a daily maximum dose of 40mg.	Placebo Placebo:2 placebo capsules dosed bid for a total of 4 capsules per day
Overall Study STARTED	79	77
Overall Study COMPLETED	55	44
Overall Study NOT COMPLETED	24	33

Reasons for withdrawal

Measure	Dronabinol Dronabinol: 20mg bid for a daily maximum dose of 40mg.	Placebo Placebo:2 placebo capsules dosed bid for a total of 4 capsules per day
Overall Study Adverse Event	1	1
Overall Study Lost to Follow-up	15	19
Overall Study Physician Decision	0	1
Overall Study Withdrawal by Subject	7	12
Overall Study non compliant	1	0

Baseline Characteristics

Dronabinol Treatment for Marijuana Addiction

Baseline characteristics by cohort

Measure	Dronabinol n=79 Participants Dronabinol: 20mg bid for a daily maximum dose of 40mg.	Placebo n=77 Participants Placebo:2 placebo capsules dosed bid for a total of 4 capsules per day	Total n=156 Participants Total of all reporting groups
Age, Continuous	36.9 years STANDARD_DEVIATION 10.8 • n=5 Participants	38.4 years STANDARD_DEVIATION 9.2 • n=7 Participants	37.9 years STANDARD_DEVIATION 10.1 • n=5 Participants
Sex: Female, Male Female	12 Participants n=5 Participants	16 Participants n=7 Participants	28 Participants n=5 Participants
Sex: Female, Male Male	67 Participants n=5 Participants	61 Participants n=7 Participants	128 Participants n=5 Participants
Region of Enrollment United States	79 participants n=5 Participants	77 participants n=7 Participants	156 participants n=5 Participants

PRIMARY outcome

Timeframe: weeks 7 and 8

Timeline Followback self report data was collected. This daily report was used to assess the proportion of patients abstinent during weeks 7 and 8 of the clinical trial.

Outcome measures

Measure	Dronabinol n=79 Participants Dronabinol: 20mg bid for a daily maximum dose of 40mg.	Placebo n=77 Participants Placebo:2 placebo capsules dosed bid for a total of 4 capsules per day
Proportion of Patients Abstinent From Marijuana During Weeks 7 and 8 of the Trial	14 participants	12 participants

Adverse Events

Dronabinol

Serious events: 3 serious events

Other events: 8 other events

Deaths: 0 deaths

Placebo

Serious events: 1 serious events

Other events: 10 other events

Deaths: 0 deaths

Serious adverse events

Measure	Dronabinol n=79 participants at risk Dronabinol: 20mg bid for a daily maximum dose of 40mg.	Placebo n=77 participants at risk Placebo:2 placebo capsules dosed bid for a total of 4 capsules per day
Respiratory, thoracic and mediastinal disorders asthma	0.00% 0/79 • Adverse events were assessed 2x/week for 12 weeks.	1.3% 1/77 • Number of events 1 • Adverse events were assessed 2x/week for 12 weeks.
Endocrine disorders diabetes	1.3% 1/79 • Number of events 1 • Adverse events were assessed 2x/week for 12 weeks.	0.00% 0/77 • Adverse events were assessed 2x/week for 12 weeks.
Injury, poisoning and procedural complications concussion	1.3% 1/79 • Number of events 1 • Adverse events were assessed 2x/week for 12 weeks.	0.00% 0/77 • Adverse events were assessed 2x/week for 12 weeks.
Gastrointestinal disorders stomach flu	1.3% 1/79 • Number of events 1 • Adverse events were assessed 2x/week for 12 weeks.	0.00% 0/77 • Adverse events were assessed 2x/week for 12 weeks.

Other adverse events

Measure	Dronabinol n=79 participants at risk Dronabinol: 20mg bid for a daily maximum dose of 40mg.	Placebo n=77 participants at risk Placebo:2 placebo capsules dosed bid for a total of 4 capsules per day
Gastrointestinal disorders nausea	6.3% 5/79 • Number of events 5 • Adverse events were assessed 2x/week for 12 weeks.	3.9% 3/77 • Number of events 3 • Adverse events were assessed 2x/week for 12 weeks.
Gastrointestinal disorders diarrhea	2.5% 2/79 • Number of events 2 • Adverse events were assessed 2x/week for 12 weeks.	7.8% 6/77 • Number of events 6 • Adverse events were assessed 2x/week for 12 weeks.
Gastrointestinal disorders GI upset	5.1% 4/79 • Number of events 4 • Adverse events were assessed 2x/week for 12 weeks.	2.6% 2/77 • Number of events 2 • Adverse events were assessed 2x/week for 12 weeks.

Additional Information

Frances R. Levin, M.D.

Columbia University

Phone: (212) 543-5896

Email: frl2@columbia.edu

Results disclosure agreements

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