Efficacy and Tolerability of Baclofen for Alcohol Dependence

Phase 2

Completed

• Conditions: Alcohol Dependence
• Interventions: Drug: baclofen; Drug: placebo; Behavioral: BRENDA counseling

• Registration Number: NCT00877734
• Lead Sponsor: University of North Carolina, Chapel Hill

Brief 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.

Study Timeline

• Study Start: 2005-04
• Primary Completion: 2007-05
• Study Completion: 2007-06
• Study First Submitted: 2008-02-07
• Study First Submitted QC: 2009-04-07
• Study First Posted: 2009-04-08
• Status Verified: 2011-04
• Last Update Submitted: 2012-09-13
• Last Update Posted: 2012-09-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	BRENDA counseling	Baclofen
1	baclofen	Baclofen
2	placebo	Placebo
2	BRENDA counseling	Placebo

Primary Outcome Measures

Name	Time	Method
% heavy drinking days	2 years

Secondary Outcome Measures

Name	Time	Method
% abstinent days	2 years
anxiety symptoms	2 years
% relapse	2 years
depression symptoms	2 years

Trial Locations

Locations (1)

University of North Carolina at Chapel Hill School of Medicine; 🇺🇸 Chapel Hill, North Carolina, United States