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NCT02011516 · ClinicalTrials.gov registry record · Phase 2
Baclofen Effects on Marijuana Dependence
A Phase 2 study, sponsored by University of Pennsylvania.
- Completed
- Registry status
- Phase 2
- Development phase
- 47
- Enrollment target
NCT02011516: Completed Phase 2 study, sponsored by University of Pennsylvania.
NCT02011516 is a Phase 2 study that has completed, run by University of Pennsylvania. The registered enrollment target is 47 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (65% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02011516, a Phase 2 study, has completed, sponsored by University of Pennsylvania.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 47 participants
- Enrollment target
Study Summary
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.
Primary Outcome
Change from positive to negative over the 12 weeks of a medication regimen
Interventions
- DRUG Placebo
- DRUG Baclofen
- BEHAVIORAL Psychosocial
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 47 participants |
| Start Date | 2013-12 |
| Est. Completion | 2015-06 |
| Phase | Phase 2 |
What the finished NCT02011516 record still lists
NCT02011516 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 47 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (65% lower).
The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.
NCT02011516 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02011516 about?
NCT02011516 is a clinical study titled "Baclofen Effects on Marijuana Dependence". 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 reminder...
What is the current status of trial NCT02011516?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 47 participants. The study started on 2013-12. Estimated completion is 2015-06.
What interventions are being tested in trial NCT02011516?
The interventions under investigation include: Placebo (DRUG), Baclofen (DRUG), Psychosocial (BEHAVIORAL).
Who is sponsoring clinical trial NCT02011516?
This trial is sponsored by University of Pennsylvania, which has 1,423 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02011516's enrollment target sits among peer trials
47 1283rd of 2000 higher than 715 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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