Topiramate for Alcohol Use in Posttraumatic Stress Disorder

University of Maryland Baltimore (UMB)

Status: Terminated

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

Treatments: Drug: Topiramate; Drug: Placebo

Study type: Interventional

Funder types: Other; Other U.S. Federal agency

Identifiers

NCT01408641

HP-00047672

Details and patient eligibility

About

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.

Enrollment: 4 patients

Sex: Male

Ages: 21 to 64 years old

Volunteers: No 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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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4 participants in 2 patient groups, including a placebo group

Topiramate

Experimental group

Description:

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

Treatment:

Drug: Topiramate

Placebo (Sugar Pill)

Placebo Comparator group

Description:

Placebo arm will receive matching capsules without topiramate.

Treatment:

Drug: Placebo