NCT00877734

Efficacy and Tolerability of Baclofen for Alcohol Dependence

Phase IIIa Trial of Baclofen for Alcohol Dependence

• Status: Completed
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 80 (actual)
• Sponsor: University of North Carolina, Chapel Hill · Academic / Other
• Sex: All
• Age: 21 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

This is a study of the efficacy and safety of baclofen for alcohol dependence. 80 outpatient subjects with DSM-IV alcohol dependence will be randomized to 10 mg three times a day (tid) baclofen or tid placebo. An effort will be made to recruit 40 men and 40 women. Subjects will receive BRENDA counseling over the 12 weeks of the trial. The Timeline Followback (TLFB) method will be used to assess drinking patterns. The primary outcome is % heavy drinking during the trial.

Detailed description

The study will explore the efficacy and tolerability of a 12-week regimen of 10 mg t.i.d. baclofen vs. placebo in conjunction with behavioral therapy for reducing heavy drinking in 80 alcohol dependent individuals. Prior studies (Addolorato et al. 2000, 2002; Flannery et al., 2004) have found that baclofen reduces self-reported anxiety and craving; therefore, the proposed study also will assess baclofen's ability to reduce symptoms of these affective states. Furthermore, in our pilot study (Flannery et al, 2004), women appeared to respond more consistently than men, and therefore the study will also be balanced by gender.

Conditions

• Alcohol Dependence

Interventions

Type	Name	Description
DRUG	baclofen	10 mg Baclofen administered tid for 11 weeks
DRUG	placebo	Placebo administered tid for 11 weeks
BEHAVIORAL	BRENDA counseling

Timeline

• Start date: 2005-04-01
• Primary completion: 2007-05-01
• Completion: 2007-06-01
• First posted: 2009-04-08
• Last updated: 2012-09-14

Locations

1 site across 1 country: United States