Baclofen Effects on Marijuana Dependence
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|ClinicalTrials.gov Identifier: NCT02011516|
Recruitment Status : Completed
First Posted : December 13, 2013
Results First Posted : June 14, 2017
Last Update Posted : June 14, 2017
Studies show that certain reminders of drug use such as the sight of someone using marijuana, pictures of blunts, particular moments throughout the day, prompt marijuana users to smoke marijuana. We are measuring the brain and behavioral responses of marijuana dependent individuals to these reminders (cues) We will examine brain responses during cue exposure and determine whether these responses are associated with treatment outcome.
We are testing the hypothesis that the medication baclofen reduces brain responses during marijuana cue exposure and/or craving in marijuana dependent individuals. Baclofen is FDA-approved for other uses, but not for the treatment of marijuana dependence. Functional magnetic resonance imaging (fMRI) will be used to measure the brain's response to marijuana cues. fMRI is a painless technique that takes special pictures of the brain (or other parts of your body). It does not involve radiation or injections.
Eligible participants will have a 50% chance of receiving placebo (sugar pill) and a 50% chance of receiving baclofen. Neither the participant nor study personnel will know whether participants are receiving baclofen or placebo. Participants will also receive twice weekly psychosocial treatment with a certified clinician. Twelve weeks of treatment will be followed by a 12 week follow up.
|Condition or disease||Intervention/treatment||Phase|
|Marijuana Dependence||Drug: Baclofen Behavioral: Psychosocial Drug: Placebo||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||47 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||A Randomized Placebo-controlled Study of Baclofen on Brain and Behavioral Outcomes in Marijuana Dependence|
|Study Start Date :||December 2013|
|Actual Primary Completion Date :||June 2015|
|Actual Study Completion Date :||June 2015|
Placebo Comparator: Sugar pill, psychosocial intervention
twice weekly appointments with a certified clinician
Other Name: Sugar pill
Active Comparator: Baclofen, psychosocial intervention
20 mg. q.i.d. twice weekly appointments with a certified clinician
- Urine Drug Screen [ Time Frame: study weeks 1-12 ]Change from positive to negative over the 12 weeks of a medication regimen
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02011516
|United States, Pennsylvania|
|University of Pennsylvania Center for Studies of Addiction|
|Philadelphia, Pennsylvania, United States, 19104|
|Principal Investigator:||Teresa R Franklin, Ph.D.||University of Pennsylvania|