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Topiramate for Alcohol Use in Posttraumatic Stress Disorder

NCT01408641 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 4

Last updated 2022-03-03

Study results available
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Summary

Alcohol abuse and dependence (alcohol use disorders, AUDs) and posttraumatic stress disorder (PTSD) are both prevalent in Veterans. Treating AUDs in Veterans with PTSD may be more difficult than treating AUDs in the general population. The FDA-approved medication topiramate has been shown to improve drinking outcomes in people with AUDs. Topiramate has also improved symptoms in people with PTSD. This study is designed to investigate whether topiramate will improve drinking outcomes in Veterans with PTSD.

Conditions

Interventions

DRUG

Topiramate

Topiramate titrated over 6 weeks to 400mg or highest tolerated dose.

DRUG

Placebo

Placebo capsules without topiramate

Sponsors & Collaborators

Principal Investigators

  • Bernard A Fischer, M.D. · Department of Veterans Affairs, University of Maryland School of Medicine

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
21 Years
Max Age
64 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-09-30
Primary Completion
2013-07-31
Completion
2013-08-31

Countries

  • United States

Study Locations

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Entities

Drugs
Diseases
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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 NCT01408641 on ClinicalTrials.gov