Topiramate for Alcohol Use in Posttraumatic Stress Disorder

Study Overview
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Brief Summary
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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.

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

Conditions
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Alcohol Dependence, Alcoholism, Alcohol Abuse, Alcohol Use Disorder, PTSD, Posttraumatic Stress Disorder

Intervention / Treatment
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* Drug: Topiramate
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 64 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 14 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 14 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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topiramate, PTSD, drinking, alcohol