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Topiramate for Alcohol Use in Posttraumatic Stress Disorder

Primary Purpose

Alcohol Dependence, Alcoholism, Alcohol Abuse

Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Topiramate
Placebo
Sponsored by
University of Maryland, Baltimore
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Alcohol Dependence focused on measuring topiramate, PTSD, drinking, alcohol

Eligibility Criteria

21 Years - 64 Years (Adult)MaleDoes not accept healthy volunteers

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)

Sites / Locations

  • Baltimore VA, VA Maryland Health Care System

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Topiramate

Placebo (Sugar Pill)

Arm Description

Topiramate arm will be titrated (dose will increase slowly) over 6 weeks to 400mg or highest tolerated dose.

Placebo arm will receive matching capsules without topiramate.

Outcomes

Primary Outcome Measures

Percentage of Heavy Drinking Days
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

Amount of PTSD Symptoms
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.

Full Information

First Posted
August 1, 2011
Last Updated
March 1, 2022
Sponsor
University of Maryland, Baltimore
Collaborators
US Department of Veterans Affairs
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1. Study Identification

Unique Protocol Identification Number
NCT01408641
Brief Title
Topiramate for Alcohol Use in Posttraumatic Stress Disorder
Official Title
A 14-week Randomized, Placebo-controlled Study of Topiramate for Alcohol Use Disorders in Veterans With Posttraumatic Stress Disorder
Study Type
Interventional

2. Study Status

Record Verification Date
March 2022
Overall Recruitment Status
Terminated
Why Stopped
Principal Investigator was deployed overseas
Study Start Date
September 2012 (undefined)
Primary Completion Date
July 2013 (Actual)
Study Completion Date
August 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Maryland, Baltimore
Collaborators
US Department of Veterans Affairs

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alcohol Dependence, Alcoholism, Alcohol Abuse, Alcohol Use Disorder, PTSD, Posttraumatic Stress Disorder
Keywords
topiramate, PTSD, drinking, alcohol

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
4 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Topiramate
Arm Type
Experimental
Arm Description
Topiramate arm will be titrated (dose will increase slowly) over 6 weeks to 400mg or highest tolerated dose.
Arm Title
Placebo (Sugar Pill)
Arm Type
Placebo Comparator
Arm Description
Placebo arm will receive matching capsules without topiramate.
Intervention Type
Drug
Intervention Name(s)
Topiramate
Other Intervention Name(s)
Topamax
Intervention Description
Topiramate titrated over 6 weeks to 400mg or highest tolerated dose.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo capsules without topiramate
Primary Outcome Measure Information:
Title
Percentage of Heavy Drinking Days
Description
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.
Time Frame
14 weeks
Secondary Outcome Measure Information:
Title
Amount of PTSD Symptoms
Description
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.
Time Frame
14 weeks

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
64 Years
Accepts Healthy Volunteers
No
Eligibility 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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bernard A Fischer, M.D.
Organizational Affiliation
Department of Veterans Affairs, University of Maryland School of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Baltimore VA, VA Maryland Health Care System
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21201
Country
United States

12. IPD Sharing Statement

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Topiramate for Alcohol Use in Posttraumatic Stress Disorder

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