A Controlled Trial of Topiramate Treatment for Alcohol Dependence in Veterans With PTSD
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 151
- 试验地点
- 1
- 主要终点
- Change in Percentage of Heavy Drinking Days Over the 12 Weeks of Study Treatment as Assessed by the Timeline Followback (TFLB)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
- •Current medications for alcohol dependence (disulfiram, naltrexone, or acamprosate) or use in the past week.
- •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 in the past 6 months or suicidal ideation in the 90 days 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.
研究组 & 干预措施
Topiramate
Topiramate capsules daily - up to 300 mg
干预措施: Topiramate (Drug)
Topiramate
Topiramate capsules daily - up to 300 mg
干预措施: Medical Management (Behavioral)
Placebo
Placebo capsules daily - up to 300 mg
干预措施: placebo (Drug)
Placebo
Placebo capsules daily - up to 300 mg
干预措施: Medical Management (Behavioral)
结局指标
主要结局
Change in Percentage of Heavy Drinking Days Over the 12 Weeks of Study Treatment as Assessed by the Timeline Followback (TFLB)
时间窗: 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.
次要结局
- 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)