Overview

Efficacy and Tolerability of Baclofen for Alcohol Dependence

Status:
Completed
Trial end date:
2007-06-01
Target enrollment:
Participant gender:
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.
Phase:
Phase 2/Phase 3
Details
Lead Sponsor:
University of North Carolina, Chapel Hill
Treatments:
Baclofen
Ethanol