A Controlled Trial of Topiramate Treatment for Alcohol Dependence in Veterans With PTSD
Overview
- Phase
- Phase 4
- Intervention
- Topiramate
- Conditions
- Alcohol Dependence
- Sponsor
- University of California, San Francisco
- Enrollment
- 151
- Locations
- 1
- Primary Endpoint
- Change in Percentage of Heavy Drinking Days Over the 12 Weeks of Study Treatment as Assessed by the Timeline Followback (TFLB)
- Status
- Completed
- Last Updated
- 4 years ago
Overview
Brief Summary
The goal of this project is to improve the treatment of veterans with co-occurring alcohol dependence and posttraumatic stress disorder (PTSD). The PI and co-investigators will conduct a controlled clinical trial of topiramate for the treatment of these co-occurring disorders.
Detailed Description
This project consists of a controlled clinical trial of topiramate treatment to reduce alcohol use and PTSD symptoms in veterans with these co-occurring disorders. This is a prospective randomized double-blind controlled parallel groups clinical trial of topiramate or or placebo up to 300 mg per day, combined with weekly alcohol counseling, over a 12-week treatment period with a week 16 follow-up. The study population consists of 150 male and female veterans between the ages of 18-69 who have concurrent diagnoses of alcohol use disorder and PTSD. Subjects meet with research staff weekly to receive study medication, manualized alcohol counseling, and research assessments. The primary treatment outcome is the percent of days of drinking; the secondary outcome is PTSD symptom severity. Exploratory measures include assessments of impulsivity and decision-making.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Male and female veterans
- •Ages18 to 69 (inclusive)
- •Current DSM-IV diagnosis of PTSD
- •Current (past month) DSM-IV diagnosis of an Alcohol Dependence
- •Level of drinking must meet criteria for "at-risk " or "heavy" drinking by NIAAA threshold (NIAAA 2007): at least 15 standard drinks per week on average over the 4 weeks prior to study entry for men and at least 8 standard drinks per week on average for women.
- •Subjects must express a desire to reduce alcohol consumption with the possible long-term goal of abstinence.
- •Female subjects must have a negative urine pregnancy test and must be either postmenopausal for at least one year, or practicing an effective method of birth control (e.g., surgically sterile, spermicide with barrier, male partner sterilization; or abstinent and agrees to continue abstinence or to use an acceptable method of contraception, as listed above, should sexual activity commence)
- •Subjects must have a Breath Alcohol Concentration (BAC) of \< 0.02% when signing 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 blood urea nitrogen (BUN) or creatinine or an estimated creatinine clearance of \< 60 mL/min
- •AST and/or ALT \>5 times the upper limit of the normal range and/or an increased serum bilirubin \>2 times the upper limit of normal.
- •Seizure disorders
- •History of glaucoma.
- •History of kidney stones.
- •Concurrent participation in another treatment study.
- •Female patients who are pregnant or lactating.
- •Current Topiramate use or use within the past 4 weeks.
Arms & Interventions
Topiramate
Topiramate capsules daily - up to 300 mg
Intervention: Topiramate
Topiramate
Topiramate capsules daily - up to 300 mg
Intervention: Medical Management
Placebo
Placebo capsules daily - up to 300 mg
Intervention: placebo
Placebo
Placebo capsules daily - up to 300 mg
Intervention: Medical Management
Outcomes
Primary Outcomes
Change in Percentage of Heavy Drinking Days Over the 12 Weeks of Study Treatment as Assessed by the Timeline Followback (TFLB)
Time Frame: Baseline to Week 12
Timeline Followback (TLFB) data was recorded using a calendar, with participants providing retrospective reports of daily drinking over the past week(s). The percent of heavy drinking days per week was calculated from the calendar data. The change in percentage of heavy drinking days was calculated by subtracting Week 0 (baseline) data from Week 12. Negative scores indicate improvement.
Secondary Outcomes
- Change in Decision-making Behavior as Assessed by the Iowa Gambling Task (IGT)(Baseline to Week 12)
- Change in PTSD Symptom Severity as Assessed by the PTSD Checklist (PCL)(Baseline to Week 12)
- Change in Impulsivity as Assessed by Delay Discounting (DD)(Baseline to Week 12)
- Change in Risk-taking Behavior as Assessed by the Balloon Analogue Risk Task (BART)(Baseline to Week 12)