NCT02003664

A Study of Baclofen ER

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

• Status: Withdrawn
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: University of Pennsylvania · Academic / Other
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Not accepted

Summary

This is a Phase II, randomized, double-blind, placebo-controlled study that will examine the efficacy of extended-release baclofen (Baclofen ER) for the treatment of cocaine dependence. The primary study outcome will be urines positive for benzoylecgonine (BE), a metabolite of cocaine, submitted during outpatient treatment (12-week) and follow-up (12-week). To examine brain mechanisms of relapse/recovery, participants will complete fMRI sessions before, during, and after treatment. Brain responses to specific probes of reward and inhibition will be used as biomarkers predicting drug use during and after the treatment.

Conditions

• Cocaine Dependence

Interventions

Type	Name	Description
DRUG	Baclofen ER	Comparison of Baclofen ER to placebo using a 2 to 1 chance of receiving Baclofen ER, the medication
DRUG	Placebo	Comparison of placebo to Baclofen ER using a 1 in 3 chance of receiving placebo

Timeline

• Start date: 2013-11-01
• Primary completion: 2014-11-01
• Completion: 2014-11-01
• First posted: 2013-12-06
• Last updated: 2016-09-08

Locations

1 site across 1 country: United States