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Topiramate Treatment of Hazardous and Harmful Alcohol Use in Veterans With TBI

NCT01750268 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 32

Last updated 2020-10-14

Study results available
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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.

Conditions

  • Traumatic Brain Injury (TBI)
  • Hazardous and Harmful Alcohol Use

Interventions

BEHAVIORAL

Medical Management Counseling

Brief alcohol and medication counseling

DRUG

Topiramate

Experimental medication

DRUG

Placebo

Placebo comparator

Sponsors & Collaborators

  • United States Department of Defense

    collaborator FED

  • Northern California Institute of Research and Education

    collaborator OTHER

  • San Francisco Veterans Affairs Medical Center

    collaborator FED

  • University of California, San Francisco

    lead OTHER

Principal Investigators

  • Steven L. Batki, MD · University of California, San Francisco

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-11-30
Primary Completion
2015-10-31
Completion
2015-10-31

Countries

  • United States

Study Locations

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Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01750268 on ClinicalTrials.gov