CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 32 enrolled
Drug / intervention
Topiramate +2 moredrug
Likely dose
Not stated in 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/NCT01750268
NCT01750268Phase 4Completed
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Topiramate Treatment of Hazardous and Harmful Alcohol Use in Veterans With TBI

University of California, San Francisco·interventional·Posted Dec 17, 2012·Updated Oct 14, 2020

In Brief

A Phase 4 clinical trial evaluating Medical Management Counseling, Topiramate, and 1 other intervention for Traumatic Brain Injury (TBI) and Hazardous and Harmful Alcohol Use. Completed, enrolled 32 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsTraumatic Brain Injury (TBI), Hazardous and Harmful Alcohol Use
CountriesUnited States
CollaboratorsUnited States Department of Defense, Northern California Institute of Research and Education, San Francisco Veterans Affairs Medical Center

Timeline

Phase 4CompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedDec 17, 2012
Enrollment StartNov 1, 2012
Primary CompletionOct 1, 2015
TodayJul 2, 2026
Enrollment to primary: 2.9 yearsPosted 13.5 years ago

Interventions

Medical Management Counselingbehavioral

Brief alcohol and medication counseling

Topiramatedrug

Experimental medication

Placebodrug

Placebo comparator