Topiramate for Alcohol Use in Posttraumatic Stress Disorder

• Status: Terminated
• Trial end date: 2013-08-01
• Target enrollment: 0
• Participant gender: Male

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.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Maryland; University of Maryland, Baltimore
• Collaborators: US Department of Veterans Affairs; VA Office of Research and Development
• Treatments: Ethanol; Topiramate

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)