CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 180 enrolled
Drug / intervention
baclofen +1 moredrug
Likely dose
baclofen 10 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01008280
NCT01008280Phase 4Completed
CompareCT.gov

Efficacy & Safety of Baclofen to Reduce Alcohol Use in Veterans With HCV

VA Office of Research and Development·interventional·Posted Nov 5, 2009·Updated Feb 8, 2016

In Brief

A Phase 4 clinical trial evaluating baclofen and placebo for Hepatitis C and Alcohol Use Disorders. Completed, enrolled 180 participants across 4 sites.

Detailed Summary

Hepatitis C (HCV) is the most common blood born virus in the United States, affecting 1.8% of the general population and more than 5% of Veterans using VA facilities. As Veterans with HCV have high rates of co-morbid alcohol use disorders that accelerate greatly the liver damage caused by HCV, a safe and effective treatment for alcohol use disorders is needed. Baclofen is a novel treatment for alcohol use disorders that has minimal effect on the liver and may represent a safe and efficacious treatment option for Veterans with HCV and co-morbid alcohol use disorders.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHepatitis C, Alcohol Use Disorders
CountriesUnited States
Collaborators--

Timeline

Phase 4CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedNov 5, 2009
Enrollment StartOct 1, 2010
Primary CompletionMar 1, 2014
Study CompletionSep 1, 2015
TodayJul 2, 2026
Enrollment to primary: 3.4 yearsPosted 16.7 years ago

Interventions

baclofendrug

baclofen 10 mg tid

placebodrug

placebo pill tid