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

Phase 4

Completed

• Conditions: Traumatic Brain Injury (TBI); Hazardous and Harmful Alcohol Use
• Interventions: Behavioral: Medical Management Counseling; Drug: Placebo; Drug: Topiramate

• Registration Number: NCT01750268
• Lead Sponsor: University of California, San Francisco

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-11
• Study First Submitted: 2012-11-28
• Study First Submitted QC: 2012-12-12
• Study First Posted: 2012-12-17
• Primary Completion: 2015-10
• Study Completion: 2015-10
• Results First Submitted: 2019-09-26
• Status Verified: 2020-09
• Results First Submitted QC: 2020-09-18
• Last Update Submitted: 2020-09-18
• Results First Posted: 2020-10-14
• Last Update Posted: 2020-10-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 32

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Topiramate	Medical Management Counseling	Topiramate capsules daily - up to 300 mg
Placebo	Medical Management Counseling	Placebo capsules daily - up 300 mg
Placebo	Placebo	Placebo capsules daily - up 300 mg
Topiramate	Topiramate	Topiramate capsules daily - up to 300 mg

Primary Outcome Measures

Name	Time	Method
Change in the Number of Drinking Days Per Week as Assessed by the Timeline Followback (TLFB)	Baseline to Week 12	Using a calendar, participants provide retrospective estimates of daily drinking over a specified period.

Secondary Outcome Measures

Name	Time	Method
Change in TBI Symptom Severity as Assessed by the Neurobehavioral Symptom Inventory (NSI)	Baseline to Week 12	Participants indicate the extent to which each of the 22 symptoms has disturbed them in the previous 2 weeks on a 5-item scale (0-none to 4-severe). The NSI total score is the sum of severity ratings of the symptoms. The scores are summed to yield a total score ranging from 0 to 88, where the higher the point value, the greater (more severe) the symptoms.

Trial Locations

Locations (1)

San Francisco VA Medical Center; 🇺🇸 San Francisco, California, United States