Trial Outcomes & Findings for Baclofen Effects on Marijuana Dependence (NCT NCT02011516)
NCT ID: NCT02011516
Last Updated: 2017-06-14
Results Overview
Change from positive to negative over the 12 weeks of a medication regimen
COMPLETED
PHASE2
47 participants
study weeks 1-12
2017-06-14
Participant Flow
Recruitment Timeframe: 12/2013-10/2014 Potential subjects were recruited via word of mouth, flyers, craigslist and targeted Facebook ads 47 potential subjects were enrolled (consented), 41 were screened, 22 passed screening, 21 baseline scan, 16 randomized, 13 treatment scan, 8 post-tx scan, 10 completed.
All enrolled participants, those that consented to study procedures, participated in a screening process that consisted of a physical and psychological evaluation. Those participants that did not meet our specific inclusion criteria, and/or those that met our exclusion criteria, were not assigned to groups. These individuals were given referrals.
Participant milestones
| Measure |
Sugar Pill, Psychosocial Intervention
twice weekly appointments with a certified clinician
Psychosocial
Placebo
|
Baclofen, Psychosocial Intervention
20 mg. q.i.d. twice weekly appointments with a certified clinician
Baclofen
Psychosocial
|
|---|---|---|
|
Overall Study
STARTED
|
8
|
8
|
|
Overall Study
COMPLETED
|
4
|
6
|
|
Overall Study
NOT COMPLETED
|
4
|
2
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Baclofen Effects on Marijuana Dependence
Baseline characteristics by cohort
| Measure |
Sugar Pill, Psychosocial Intervention
n=8 Participants
twice weekly appointments with a certified clinician
Psychosocial
Placebo
|
Baclofen, Psychosocial Intervention
n=8 Participants
20 mg. q.i.d. twice weekly appointments with a certified clinician
Baclofen
Psychosocial
|
Total
n=16 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
|
8 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
8 participants
n=5 Participants
|
8 participants
n=7 Participants
|
16 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: study weeks 1-12Change from positive to negative over the 12 weeks of a medication regimen
Outcome measures
| Measure |
Sugar Pill, Psychosocial Intervention
n=8 Participants
twice weekly appointments with a certified clinician
Psychosocial
Placebo
|
Baclofen, Psychosocial Intervention
n=8 Participants
20 mg. q.i.d. twice weekly appointments with a certified clinician
Baclofen
Psychosocial
|
|---|---|---|
|
Urine Drug Screen
|
0 Participants
|
0 Participants
|
Adverse Events
Sugar Pill, Psychosocial Intervention
Baclofen, Psychosocial Intervention
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Sugar Pill, Psychosocial Intervention
n=8 participants at risk
twice weekly appointments with a certified clinician
Psychosocial
Placebo
|
Baclofen, Psychosocial Intervention
n=8 participants at risk
20 mg. q.i.d. twice weekly appointments with a certified clinician
Baclofen
Psychosocial
|
|---|---|---|
|
General disorders
Headache
|
37.5%
3/8 • study weeks 1-12
|
0.00%
0/8 • study weeks 1-12
|
|
Nervous system disorders
Drowsy/Sluggish
|
37.5%
3/8 • study weeks 1-12
|
12.5%
1/8 • study weeks 1-12
|
|
Gastrointestinal disorders
Constipation
|
12.5%
1/8 • study weeks 1-12
|
0.00%
0/8 • study weeks 1-12
|
|
Gastrointestinal disorders
Diarrhea
|
12.5%
1/8 • study weeks 1-12
|
0.00%
0/8 • study weeks 1-12
|
|
Gastrointestinal disorders
Flatulence
|
12.5%
1/8 • study weeks 1-12
|
0.00%
0/8 • study weeks 1-12
|
|
Gastrointestinal disorders
Nausea
|
12.5%
1/8 • study weeks 1-12
|
0.00%
0/8 • study weeks 1-12
|
|
General disorders
Dry Mouth
|
12.5%
1/8 • study weeks 1-12
|
0.00%
0/8 • study weeks 1-12
|
|
Nervous system disorders
Slowed Cognition
|
12.5%
1/8 • study weeks 1-12
|
0.00%
0/8 • study weeks 1-12
|
|
Nervous system disorders
"High" Feeling
|
12.5%
1/8 • study weeks 1-12
|
0.00%
0/8 • study weeks 1-12
|
|
Gastrointestinal disorders
Metallic Taste
|
12.5%
1/8 • study weeks 1-12
|
0.00%
0/8 • study weeks 1-12
|
|
Gastrointestinal disorders
Abdominal Cramping
|
0.00%
0/8 • study weeks 1-12
|
12.5%
1/8 • study weeks 1-12
|
|
Gastrointestinal disorders
Increase in Bowel Movements
|
0.00%
0/8 • study weeks 1-12
|
12.5%
1/8 • study weeks 1-12
|
|
Metabolism and nutrition disorders
Unintended Weight Loss
|
0.00%
0/8 • study weeks 1-12
|
12.5%
1/8 • study weeks 1-12
|
Additional Information
Teresa R. Franklin, Ph.D., Research Associate Professor of Neuroscience in Psychiatry
University of Pennsylvania
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place