Topiramate Treatment of Alcohol Use Disorders in Veterans With Post Traumatic Stress Disorder (PTSD): A Pilot Controlled Trial of Augmentation Therapy

• Status: Completed
• Trial end date: 2013-12-01
• Target enrollment: 0
• Participant gender: All

Summary

The proposed project aims to:

1. Obtain a preliminary assessment of the efficacy of topiramate treatment in reducing alcohol use in veterans with Post Traumatic Stress Disorder (PTSD) and alcohol dependence;

2. Obtain preliminary assessments of safety/tolerability of topiramate in these patients;

3. Assess the feasibility of recruitment and retention for topiramate treatment in this comorbid population; and 4) to inform the design of a planned subsequent larger controlled trial of topiramate.

PRIMARY HYPOTHESIS: Topiramate treatment combined with Medical Management alcohol counseling will be associated with a significant decrease in percent drinking days from baseline to end of treatment.

SECONDARY HYPOTHESIS: There will be significantly less percent drinking days in the topiramate treatment group compared to the placebo group.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of California, San Francisco
• Collaborators: United States Department of Defense; US Department of Veterans Affairs; VA Office of Research and Development
• Treatments: Ethanol; Topiramate

Criteria

Inclusion Criteria:

• Male and female outpatient veterans.

• Current DSM-IV diagnosis of PTSD.

• Current (past month) DSM-IV diagnosis of an Alcohol Use Disorder.

• Must meet criteria for "heavy" or "at-risk" drinking by NIAAA thresholds.

• Receiving treatment for PTSD.

• Must express desire to reduce alcohol consumption.

• Female subjects must have negative urine pregnancy test and must be either postmenopausal for at least one year, or practicing an effective method of birth control.

• Must have a BAC of less than 0.02% when signing the informed consent.

Exclusion Criteria:

• Psychotic disorders, bipolar disorder, dementia, or other psychiatric disorders judged to be unstable.

• Subjects known to have clinically significant unstable medical conditions, including but not limited to: clinically significant renal disease and/or impaired renal function as defined by clinically significant elevation of BUN or creatinine or an estimated creatinine clearance of < 60 mL/min; AST (SGOT) and/or ALT (SGPT) >3 times the upper limit of the normal range and/or an increased serum bilirubin >2 times the upper limit of normal; seizure disorders.

• Subjects with glaucoma.

• Subjects with a history of kidney stones.

• Subjects with a history of renal disease.

• Concurrent participation in another treatment study.

• Female patients who are pregnant or lactating.

• Current topiramate use or use within the past 4 weeks.

• Current medications for alcohol dependence or use within the past 4 weeks.

• Needing acute medical detoxification from alcohol based on a score of 12 or more on the Clinical Institute Withdrawal Assessment of Alcohol Scale (CIWA-AD);

• Subjects who are legally mandated to participate in an alcohol treatment program.

• Subjects who have had a suicide attempt or suicidal ideation in the 6 months prior to enrollment.

• Subjects who have previously been treated with topiramate for any reason and discontinued treatment due to an adverse event or due to a hypersensitivity reaction to topiramate,

• Subjects with seizure disorders that require anticonvulsant medications

• Subjects currently being treated with another anticonvulsant.

• Subjects who in the opinion of the investigator should not be enrolled in the study because of the precautions,warnings or contraindications outlined in the topiramate package insert.