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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.
 
ClinicalTrials.gov Identifier: NCT01408641
Recruitment Status : Terminated (Principal Investigator was deployed overseas)
First Posted : August 3, 2011
Results First Posted : May 24, 2018
Last Update Posted : March 3, 2022
Sponsor:
Collaborator:
US Department of Veterans Affairs
Information provided by (Responsible Party):
MPRC, University of Maryland, Baltimore

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 Phase
Alcohol Dependence Alcoholism Alcohol Abuse Alcohol Use Disorder PTSD Posttraumatic Stress Disorder Drug: Topiramate Drug: Placebo Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 4 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
Actual Primary Completion Date : July 2013
Actual Study Completion Date : August 2013

Resource links provided by the National Library of Medicine

Drug Information available for: Topiramate

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. 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.


Secondary Outcome Measures :
  1. 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.



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
Criteria

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 ClinicalTrials.gov identifier (NCT number): NCT01408641


Locations
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United States, Maryland
Baltimore VA, VA Maryland Health Care System
Baltimore, Maryland, United States, 21201
Sponsors and Collaborators
University of Maryland, Baltimore
US Department of Veterans Affairs
Investigators
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Principal Investigator: Bernard A Fischer, M.D. Department of Veterans Affairs, University of Maryland School of Medicine
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Responsible Party: MPRC, Physician, Maryland Psychiatric Research Center, Outpatient Research Program, University of Maryland, Baltimore
ClinicalTrials.gov Identifier: NCT01408641    
Other Study ID Numbers: HP-00047672
First Posted: August 3, 2011    Key Record Dates
Results First Posted: May 24, 2018
Last Update Posted: March 3, 2022
Last Verified: March 2022
Keywords provided by MPRC, University of Maryland, Baltimore:
topiramate
PTSD
drinking
alcohol
Additional relevant MeSH terms:
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Disease
Alcoholism
Stress Disorders, Traumatic
Alcohol Drinking
Stress Disorders, Post-Traumatic
Pathologic Processes
Trauma and Stressor Related Disorders
Mental Disorders
Drinking Behavior
Alcohol-Related Disorders
Substance-Related Disorders
Chemically-Induced Disorders
Topiramate
Anticonvulsants
Hypoglycemic Agents
Physiological Effects of Drugs