Trial Outcomes & Findings for Effect of Baclofen on Marijuana Withdrawal and Relapse (NCT NCT00373295)
NCT ID: NCT00373295
Last Updated: 2017-05-10
Results Overview
This is a measure of marijuana self-administration and relapse since each initial puff costs $7 and is a burden to overcome just to smoke. Over each 3 day period, the puffs chosen by each participant is averaged for a single value.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
13 participants
Primary outcome timeframe
Days 1-3 (Baseline) and Days 6-8 (Relapse Phase)
Results posted on
2017-05-10
Participant Flow
13 participants were enrolled, but 10 participants were randomized. Three volunteers (1 female, 2 male) dropped out of the study during the marijuana abstinence phase (two were on baclofen and one was on placebo).
Participant milestones
| Measure |
Baclofen 60 mg, Placebo, Baclofen 90 mg
participants received baclofen (60 mg/day) for 8 days, followed by placebo for 8 days, then baclofen (90mg/day) for 8 days.
|
Baclofen 90 mg, Placebo, Baclofen 60 mg
participants received baclofen (90mg/day) for 8 days, followed by placebo for 8 days, then baclofen (60mg/day) for 8 days.
|
Baclofen 60 mg, Baclofen 90 mg, Placebo
participants received baclofen (60mg/day) for 8 days, followed by baclofen (90mg/day) for 8 days, then placebo for 8 days.
|
Baclofen 90 mg, Baclofen 60 mg, Placebo
participants received baclofen (90mg/day) for 8 days, followed by baclofen (60mg/day) for 8 days, and then placebo for 8 days.
|
Placebo, Baclofen 90 mg, Baclofen 60 mg
participants received placebo for 8 days, followed by baclofen (90mg/day) for 8 days, then baclofen (60mg/day) for 8 days.
|
Placebo, Baclofen 60 mg, Baclofen 90 mg
participants received placebo for 8 days, followed by baclofen (60mg/day) for 8 days, then baclofen (90mg/day) for 8 days.
|
|---|---|---|---|---|---|---|
|
Intervention 1 (8 Days)
STARTED
|
2
|
3
|
1
|
2
|
3
|
2
|
|
Intervention 1 (8 Days)
COMPLETED
|
2
|
1
|
1
|
2
|
2
|
2
|
|
Intervention 1 (8 Days)
NOT COMPLETED
|
0
|
2
|
0
|
0
|
1
|
0
|
|
Intervention 2 (8 Days)
STARTED
|
2
|
1
|
1
|
2
|
2
|
2
|
|
Intervention 2 (8 Days)
COMPLETED
|
2
|
1
|
1
|
2
|
2
|
2
|
|
Intervention 2 (8 Days)
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Intervention 3 (8 Days)
STARTED
|
2
|
1
|
1
|
2
|
2
|
2
|
|
Intervention 3 (8 Days)
COMPLETED
|
2
|
1
|
1
|
2
|
2
|
2
|
|
Intervention 3 (8 Days)
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
| Measure |
Baclofen 60 mg, Placebo, Baclofen 90 mg
participants received baclofen (60 mg/day) for 8 days, followed by placebo for 8 days, then baclofen (90mg/day) for 8 days.
|
Baclofen 90 mg, Placebo, Baclofen 60 mg
participants received baclofen (90mg/day) for 8 days, followed by placebo for 8 days, then baclofen (60mg/day) for 8 days.
|
Baclofen 60 mg, Baclofen 90 mg, Placebo
participants received baclofen (60mg/day) for 8 days, followed by baclofen (90mg/day) for 8 days, then placebo for 8 days.
|
Baclofen 90 mg, Baclofen 60 mg, Placebo
participants received baclofen (90mg/day) for 8 days, followed by baclofen (60mg/day) for 8 days, and then placebo for 8 days.
|
Placebo, Baclofen 90 mg, Baclofen 60 mg
participants received placebo for 8 days, followed by baclofen (90mg/day) for 8 days, then baclofen (60mg/day) for 8 days.
|
Placebo, Baclofen 60 mg, Baclofen 90 mg
participants received placebo for 8 days, followed by baclofen (60mg/day) for 8 days, then baclofen (90mg/day) for 8 days.
|
|---|---|---|---|---|---|---|
|
Intervention 1 (8 Days)
Withdrawal by Subject
|
0
|
2
|
0
|
0
|
1
|
0
|
Baseline Characteristics
Effect of Baclofen on Marijuana Withdrawal and Relapse
Baseline characteristics by cohort
| Measure |
All Study Participants
n=10 Participants
Participants received placebo, baclofen (60mg) and baclofen (90mg) and smoked Marijuana (5.3% THC).
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
10 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
9 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
10 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Days 1-3 (Baseline) and Days 6-8 (Relapse Phase)This is a measure of marijuana self-administration and relapse since each initial puff costs $7 and is a burden to overcome just to smoke. Over each 3 day period, the puffs chosen by each participant is averaged for a single value.
Outcome measures
| Measure |
Baclofen 60, Marijuana
n=13 Participants
baclofen (60 mg)/day
Baclofen: measured baclofen's effects on marijuana withdrawal and relapse relative to placebo
Marijuana: measured baclofen's effects on marijuana withdrawal and relapse
|
Placebo, Marijuana
n=13 Participants
|
Baclofen 90, Marijuana
n=13 Participants
baclofen (90 mg)/day
Baclofen: measured baclofen's effects on marijuana withdrawal and relapse relative to placebo
Marijuana: measured baclofen's effects on marijuana withdrawal and relapse
|
|---|---|---|---|
|
Measure of Relapse: Change in Money Spent Between Baseline and Relapse Phase
|
7.15 dollars spent on marijuana
Standard Deviation 1.85
|
9.77 dollars spent on marijuana
Standard Deviation 2.30
|
7.25 dollars spent on marijuana
Standard Deviation 2.10
|
Adverse Events
Baclofen 60, Marijuana
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Baclofen 90, Marijuana
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Placebo, Marijuana
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Baclofen 60, Marijuana
n=13 participants at risk
baclofen (60 mg)/day
Baclofen: measured baclofen's effects on marijuana withdrawal and relapse relative to placebo
Marijuana: measured baclofen's effects on marijuana withdrawal and relapse
|
Baclofen 90, Marijuana
n=13 participants at risk
baclofen (90 mg)/day
Baclofen: measured baclofen's effects on marijuana withdrawal and relapse relative to placebo
Marijuana: measured baclofen's effects on marijuana withdrawal and relapse
|
Placebo, Marijuana
n=13 participants at risk
Marijuana: measured baclofen's effects on marijuana withdrawal and relapse
|
|---|---|---|---|
|
Social circumstances
mild headache
|
15.4%
2/13 • Number of events 2
|
0.00%
0/13
|
0.00%
0/13
|
Additional Information
Dr. Margaret Haney
New York State Psychiatric Institute
Phone: 646-774-6129
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place