CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 47 enrolled
Drug / intervention
Baclofen +2 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02011516
NCT02011516Phase 2Completed

A Randomized Placebo-controlled Study of Baclofen on Brain and Behavioral Outcomes in Marijuana Dependence

University of Pennsylvania·interventional·Posted Dec 13, 2013·Updated Jun 14, 2017

In Brief

A Phase 2 clinical trial evaluating Baclofen, Psychosocial, and 1 other intervention for Marijuana Dependence. Completed, enrolled 47 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States

Timeline

Phase 2CompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedDec 13, 2013
Enrollment StartDec 1, 2013
Primary CompletionJun 1, 2015
TodayJul 2, 2026
Enrollment to primary: 1.5 yearsPosted 12.6 years ago

Interventions

Baclofendrug

Psychosocialbehavioral

Placebodrug