Topiramate for Alcohol Use in Posttraumatic Stress Disorder

March 1, 2022 updated by: MPRC, University of Maryland, Baltimore

A 14-week Randomized, Placebo-controlled Study of Topiramate for Alcohol Use Disorders in Veterans With Posttraumatic Stress Disorder

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

4

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Maryland
      • Baltimore, Maryland, United States, 21201
        • Baltimore VA, VA Maryland Health Care System

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years to 64 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

Inclusion Criteria:

  • Male
  • Ages 21-64
  • Diagnosis of PTSD via a score of 50 or higher on the Clinician Administered PTSD Scale (CAPS)
  • Alcohol abuse or dependence per diagnosis in the medical record -or- by consuming more than 35 standard drinks per week over the previous 4 weeks as measured by the Timeline Follow-Back Interview
  • A desire to reduce drinking behavior
  • Any Race/Ethnicity

Exclusion Criteria:

  • Currently taking a carbonic anhydrase inhibitor (e.g. zonisamide, acetazolamide, dichlorphenamide)
  • Currently taking or have taken in the previous 3 months: acamprosate, naltrexone, disulfiram, topiramate
  • Change in benzodiazepine dose within the previous 3 months
  • Change in other (non-benzodiazepine) medication dose within the last 4 weeks
  • Seizure disorder documented in the medical record
  • Head trauma with loss of consciousness for greater than 30 minutes -or- a diagnosis of post-concussive syndrome documented in the medical record
  • Suicide attempt within the previous 3 months or suicidal ideation within the previous 4 weeks
  • A history of kidney stones
  • A history of glaucoma
  • ALT or AST liver enzymes elevated more than twice the upper limit of normal
  • More than 4 unsuccessful attempts at inpatient alcohol treatment
  • Medically unstable (including significant hypertension despite adequate treatment)
  • A history of delirium tremens ("DTs") or alcohol withdrawal seizure
  • Compulsory treatment to avoid legal consequences (e.g. imprisonment)
  • Currently in a setting without access to alcohol (e.g. locked inpatient unit)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Topiramate
Topiramate arm will be titrated (dose will increase slowly) over 6 weeks to 400mg or highest tolerated dose.
Drug: Topiramate
Topiramate titrated over 6 weeks to 400mg or highest tolerated dose.
Other Names:
  • Topamax
Placebo Comparator: Placebo (Sugar Pill)
Placebo arm will receive matching capsules without topiramate.
Drug: Placebo
Placebo capsules without topiramate

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of Heavy Drinking Days
Time Frame: 14 weeks
The Alcohol Timeline Follow Back (TLFB) interview was conducted to establish a baseline drinking pattern over the previous 90 days and confirm the presence of an alcohol use disorder (defined as consumption of greater than 35 standard drinks per week over the previous 4 weeks). The TLFB involves asking participants to retrospectively report their drinking days using a calendar.
14 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Amount of PTSD Symptoms
Time Frame: 14 weeks
The Clinician Administered PTSD Scale (CAPS) contains 30 questions relating to PTSD symptoms. Each question asks about both the frequency and the severity of each symptom. These questions are split into categories. Each criterion has several questions, and scores for each criterion are added up at the end. To meet criteria for a symptom, a patient must meet criteria in both frequency and intensity score for each item. Frequency and intensity and then combined to form a single severity score. Severity scores range from 0-4, with 0 being absent to 4 being extreme/incapacitating.
14 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Maryland, Baltimore

Collaborators

US Department of Veterans Affairs

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2012

Primary Completion (Actual)

July 1, 2013

Study Completion (Actual)

August 1, 2013

Study Registration Dates

First Submitted

August 1, 2011

First Submitted That Met QC Criteria

August 2, 2011

First Posted (Estimate)

August 3, 2011

Study Record Updates

Last Update Posted (Actual)

March 3, 2022

Last Update Submitted That Met QC Criteria

March 1, 2022

Last Verified

March 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HP-00047672

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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