drugset / Trial / NCT00877734

Efficacy and Tolerability of Baclofen for Alcohol Dependence

NCT00877734

Phase 2/3 Completed 80 enrolled University of North Carolina, Chapel Hill
RandomizedParallel-groupDouble-blindTreatment

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.

Timeline

Start
2005-04
Primary completion
2007-05
Completion
2007-06

Drugs

EvaluationDrugModalityDoseRoute
Subject Baclofen Small molecule 10 mg

Indications