Topiramate Treatment of Hazardous and Harmful Alcohol Use in Veterans With TBI
Overview
- Phase
- Phase 4
- Intervention
- Medical Management Counseling
- Conditions
- Traumatic Brain Injury (TBI)
- Sponsor
- University of California, San Francisco
- Enrollment
- 32
- Locations
- 1
- Primary Endpoint
- Change in the Number of Drinking Days Per Week as Assessed by the Timeline Followback (TLFB)
- Status
- Completed
- Last Updated
- 5 years ago
Overview
Brief Summary
The goal of the proposed project is to improve the treatment of veterans with co-occurring traumatic brain injury (TBI) and hazardous or harmful alcohol use. The PI and coinvestigators will conduct a pilot controlled clinical trial of topiramate for the treatment of these co-occurring disorders.
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
Topiramate
Topiramate capsules daily - up to 300 mg
Intervention: Medical Management Counseling
Topiramate
Topiramate capsules daily - up to 300 mg
Intervention: Topiramate
Placebo
Placebo capsules daily - up 300 mg
Intervention: Medical Management Counseling
Placebo
Placebo capsules daily - up 300 mg
Intervention: Placebo
Outcomes
Primary Outcomes
Change in the Number of Drinking Days Per Week as Assessed by the Timeline Followback (TLFB)
Time Frame: Baseline to Week 12
Using a calendar, participants provide retrospective estimates of daily drinking over a specified period.
Secondary Outcomes
- Change in TBI Symptom Severity as Assessed by the Neurobehavioral Symptom Inventory (NSI)(Baseline to Week 12)