Trial Outcomes & Findings for Effects of Dronabinol (Oral THC) on Cannabis Use (NCT NCT01394185)
NCT ID: NCT01394185
Last Updated: 2017-08-03
Results Overview
Participants will be able to self-administer cannabis cigarettes (weighing about 0.8 grams and with about 6% THC) under a progressive ratio schedule. The number of progressive ratios completed (and thus, cannabis cigarettes consumed) is the primary study endpoint
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
25 participants
Primary outcome timeframe
12-day Dronabinol maintenance period
Results posted on
2017-08-03
Participant Flow
Participant milestones
| Measure |
Placebo, 120mg, 240mg
Participants received dronabinol for 12 days in the above order in a within-subject crossover
|
120mg, 240mg, Placebo
Participants received dronabinol for 12 days in the above order in a within-subject crossover
|
240mg, 120mg, Placebo
Participants received dronabinol for 12 days in the above order in a within-subject crossover
|
120mg, Placebo, 240mg
Participants received dronabinol for 12 days in the above order in a within-subject crossover
|
240mg, Placebo, 120mg
Participants received dronabinol for 12 days in the above order in a within-subject crossover
|
Placebo, 240mg, 120mg
Participants received dronabinol for 12 days in the above order in a within-subject crossover
|
|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
8
|
2
|
2
|
4
|
6
|
3
|
|
Overall Study
COMPLETED
|
2
|
2
|
2
|
3
|
2
|
2
|
|
Overall Study
NOT COMPLETED
|
6
|
0
|
0
|
1
|
4
|
1
|
Reasons for withdrawal
| Measure |
Placebo, 120mg, 240mg
Participants received dronabinol for 12 days in the above order in a within-subject crossover
|
120mg, 240mg, Placebo
Participants received dronabinol for 12 days in the above order in a within-subject crossover
|
240mg, 120mg, Placebo
Participants received dronabinol for 12 days in the above order in a within-subject crossover
|
120mg, Placebo, 240mg
Participants received dronabinol for 12 days in the above order in a within-subject crossover
|
240mg, Placebo, 120mg
Participants received dronabinol for 12 days in the above order in a within-subject crossover
|
Placebo, 240mg, 120mg
Participants received dronabinol for 12 days in the above order in a within-subject crossover
|
|---|---|---|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
2
|
0
|
0
|
0
|
1
|
0
|
|
Overall Study
Change in protocol
|
3
|
0
|
0
|
0
|
3
|
0
|
|
Overall Study
Protocol Violation
|
1
|
0
|
0
|
1
|
0
|
1
|
Baseline Characteristics
Effects of Dronabinol (Oral THC) on Cannabis Use
Baseline characteristics by cohort
| Measure |
All Participants
n=25 Participants
Participants received dronabinol (PL, 120mg, 240mg/day) in a randomized within-subject crossover design
|
|---|---|
|
Age, Continuous
|
25 years
STANDARD_DEVIATION 5 • n=99 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
20 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
25 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Black or African American
|
23 Participants
n=99 Participants
|
|
Race (NIH/OMB)
White
|
1 Participants
n=99 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
|
Region of Enrollment
United States
|
25 participants
n=99 Participants
|
PRIMARY outcome
Timeframe: 12-day Dronabinol maintenance periodParticipants will be able to self-administer cannabis cigarettes (weighing about 0.8 grams and with about 6% THC) under a progressive ratio schedule. The number of progressive ratios completed (and thus, cannabis cigarettes consumed) is the primary study endpoint
Outcome measures
| Measure |
Placebo
n=13 Participants
Placebo maintenance period
|
120mg Dronabinol
n=13 Participants
120mg/day (40mg tid) dronabinol maintenance period
|
240mg Dronabinol
n=13 Participants
240mg/day (80mg tid) dronabinol maintenance period
|
|---|---|---|---|
|
Marijuana Self-administration - Progressive Ratio
|
5.2 Progressive Ratios Completed
Standard Error 0.2
|
4.5 Progressive Ratios Completed
Standard Error 0.2
|
4.4 Progressive Ratios Completed
Standard Error 0.2
|
PRIMARY outcome
Timeframe: 12-day Dronabinol maintenance periodParticipants will be able to self-administer cannabis cigarettes (weighing about 0.8 grams and with about 6% THC) in 5 discrete choices each day between one cannabis cigarette and $1. The number of cannabis cigarettes chosen (and subsequently self-administered) is the primary study endpoint
Outcome measures
| Measure |
Placebo
n=13 Participants
Placebo maintenance period
|
120mg Dronabinol
n=13 Participants
120mg/day (40mg tid) dronabinol maintenance period
|
240mg Dronabinol
n=13 Participants
240mg/day (80mg tid) dronabinol maintenance period
|
|---|---|---|---|
|
Marijuana Self-administration - Drug Vs Money Choice
|
3.5 Cannabis Cigarettes Chosen
Standard Error 0.6
|
2.3 Cannabis Cigarettes Chosen
Standard Error 0.4
|
2.5 Cannabis Cigarettes Chosen
Standard Error 0.5
|
Adverse Events
Placebo
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
120mg Dronabinol
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
240mg Dronabinol
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place