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

Completed · Phase 4 · Has a placebo group

Conditions studied: PTSD, Alcohol Abuse, Alcoholism

In brief

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.

Key facts

Study ID

NCT01087736

Run by

University of California, San Francisco

People needed

30

Starts

2010-04-01

Expected to finish

2013-12-01

Last updated by the study team

2014-06-03

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• San Francisco VA Medical Center — San Francisco, California, United States

Full record on ClinicalTrials.gov

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