Topiramate for Alcohol Use in Posttraumatic Stress Disorder

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01408641
Recruitment Status : Unknown
Verified September 2012 by Bernard Fischer, MD, University of Maryland.
Recruitment status was:  Recruiting
First Posted : August 3, 2011
Last Update Posted : September 12, 2012
VA Office of Research and Development
Information provided by (Responsible Party):
Bernard Fischer, MD, University of Maryland

Brief 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.

Condition or disease Intervention/treatment
Alcohol Dependence Alcoholism Alcohol Abuse Alcohol Use Disorder PTSD Posttraumatic Stress Disorder Drug: Topiramate Drug: Placebo

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A 14-week Randomized, Placebo-controlled Study of Topiramate for Alcohol Use Disorders in Veterans With Posttraumatic Stress Disorder
Study Start Date : September 2012
Estimated Primary Completion Date : July 2013
Estimated Study Completion Date : August 2013

Resource links provided by the National Library of Medicine

Drug Information available for: Topiramate
U.S. FDA Resources

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 Name: Topamax
Placebo Comparator: Placebo (Sugar Pill)
Placebo arm will receive matching capsules without topiramate.
Drug: Placebo
Placebo capsules without topiramate

Primary Outcome Measures :
  1. Number of days of Heavy Drinking [ Time Frame: 14 weeks ]

Secondary Outcome Measures :
  1. Number of Days Abstinent [ Time Frame: 14 weeks ]
  2. Amount of PTSD Symptoms [ Time Frame: 14 weeks ]
  3. Number of Memory/Cognitive Complaints [ Time Frame: 14 weeks ]

Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years to 64 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01408641

Contact: Jennifer Duncan (410)637-1432

United States, Maryland
Baltimore VA, VA Maryland Health Care System Recruiting
Baltimore, Maryland, United States, 21201
Principal Investigator: Bernard A Fischer, M.D.         
Sponsors and Collaborators
University of Maryland
VA Office of Research and Development
Principal Investigator: Bernard A Fischer, M.D. Department of Veterans Affairs, University of Maryland School of Medicine

Responsible Party: Bernard Fischer, MD, Physician, Maryland Psychiatric Research Center, Outpatient Research Program, University of Maryland Identifier: NCT01408641     History of Changes
Other Study ID Numbers: HP-00047672 (UMD IRB#)
First Posted: August 3, 2011    Key Record Dates
Last Update Posted: September 12, 2012
Last Verified: September 2012

Keywords provided by Bernard Fischer, MD, University of Maryland:

Additional relevant MeSH terms:
Stress Disorders, Traumatic
Stress Disorders, Post-Traumatic
Alcohol Drinking
Pathologic Processes
Trauma and Stressor Related Disorders
Mental Disorders
Alcohol-Related Disorders
Substance-Related Disorders
Chemically-Induced Disorders
Drinking Behavior
Anti-Infective Agents, Local
Anti-Infective Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Neuroprotective Agents
Protective Agents
Anti-Obesity Agents