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

NCT01087736 Phase 4 COMPLETED Results posted

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.

Details

Lead sponsor	University of California, San Francisco
Phase	Phase 4
Status	COMPLETED
Enrolment	30
Start date	2010-04
Completion	2013-12

Conditions

• PTSD
• Alcohol Abuse
• Alcoholism

Interventions

• Topiramate
• Placebo administration

Primary outcomes

• Percent Drinking Days (%DD) — Weekly, weeks 1-12, average
  Alcohol consumption was assessed at baseline and weekly during the treatment phase (12 weeks) using the Time Line Follow Back (TLFB) interview which yields number of days of alcohol use (DD). DD: day on which alcohol was consumed Standard alcoholic drink defined as containing 13.6 g of pure alcohol.

Countries

United States