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Efficacy and Tolerability of Baclofen for Alcohol Dependence

NCT00877734 · Status: COMPLETED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2012-09-14

No results posted yet for this study

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.

Conditions

  • Alcohol Dependence

Interventions

DRUG

baclofen

10 mg Baclofen administered tid for 11 weeks

DRUG

placebo

Placebo administered tid for 11 weeks

BEHAVIORAL

BRENDA counseling

Sponsors & Collaborators

  • University of North Carolina, Chapel Hill

    lead OTHER

Principal Investigators

  • James C Garbutt, MD · UNC Department of Psychiatry

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
21 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2005-04-30
Primary Completion
2007-05-31
Completion
2007-06-30

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00877734 on ClinicalTrials.gov