Topiramate for Alcohol Use in Posttraumatic Stress Disorder

Not Applicable

Terminated

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

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.

Recruitment & Eligibility

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)

Arm && Interventions

Group	Intervention	Description
Placebo (Sugar Pill)	Placebo	Placebo arm will receive matching capsules without topiramate.
Topiramate	Topiramate	Topiramate arm will be titrated (dose will increase slowly) over 6 weeks to 400mg or highest tolerated dose.

Primary Outcome Measures

Name	Time	Method
Percentage of Heavy Drinking Days	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

Name	Time	Method
Amount of PTSD Symptoms	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.