Overview

Topiramate Treatment of Alcohol Use Disorders in Veterans With Post Traumatic Stress Disorder (PTSD): A Pilot Controlled Trial of Augmentation Therapy

Status:
Completed

Trial end date:
2013-12-01

Target enrollment:

Participant gender:

Summary

The proposed project aims to: 1. Obtain a preliminary assessment of the efficacy of topiramate treatment in reducing alcohol use in veterans with Post Traumatic Stress Disorder (PTSD) and alcohol dependence; 2. Obtain preliminary assessments of safety/tolerability of topiramate in these patients; 3. Assess the feasibility of recruitment and retention for topiramate treatment in this comorbid population; and 4) to inform the design of a planned subsequent larger controlled trial of topiramate. PRIMARY HYPOTHESIS: Topiramate treatment combined with Medical Management alcohol counseling will be associated with a significant decrease in percent drinking days from baseline to end of treatment. SECONDARY HYPOTHESIS: There will be significantly less percent drinking days in the topiramate treatment group compared to the placebo group.

Phase:

Phase 4

Details

Lead Sponsor:

University of California, San Francisco

Collaborators:

United States Department of Defense
US Department of Veterans Affairs
VA Office of Research and Development

Treatments:

Ethanol
Topiramate