NCT01749215

A Controlled Trial of Topiramate Treatment for Alcohol Dependence in Veterans With PTSD

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 151 (actual)
• Sponsor: University of California, San Francisco · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

The goal of this project is to improve the treatment of veterans with co-occurring alcohol dependence and posttraumatic stress disorder (PTSD). The PI and co-investigators will conduct a controlled clinical trial of topiramate for the treatment of these co-occurring disorders.

Detailed description

This project consists of a controlled clinical trial of topiramate treatment to reduce alcohol use and PTSD symptoms in veterans with these co-occurring disorders. This is a prospective randomized double-blind controlled parallel groups clinical trial of topiramate or or placebo up to 300 mg per day, combined with weekly alcohol counseling, over a 12-week treatment period with a week 16 follow-up. The study population consists of 150 male and female veterans between the ages of 18-69 who have concurrent diagnoses of alcohol use disorder and PTSD. Subjects meet with research staff weekly to receive study medication, manualized alcohol counseling, and research assessments. The primary treatment outcome is the percent of days of drinking; the secondary outcome is PTSD symptom severity. Exploratory measures include assessments of impulsivity and decision-making.

Conditions

• Alcohol Dependence
• Posttraumatic Stress Disorder (PTSD)

Interventions

Type	Name	Description
DRUG	Topiramate	Experimental study drug
DRUG	placebo	Placebo comparator
BEHAVIORAL	Medical Management	Brief alcohol counseling

Timeline

• Start date: 2013-02-01
• Primary completion: 2019-07-01
• Completion: 2019-07-01
• First posted: 2012-12-13
• Last updated: 2021-06-21
• Results posted: 2021-06-21

Locations

1 site across 1 country: United States