A 14-week Randomized, Placebo-controlled Study of Topiramate for Alcohol Use Disorders in Veterans With Posttraumatic Stress Disorder
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 4
- 试验地点
- 1
- 主要终点
- Percentage of Heavy Drinking Days
研究概览
简要总结
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.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 21 Years 至 64 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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)
研究组 & 干预措施
Topiramate
Topiramate arm will be titrated (dose will increase slowly) over 6 weeks to 400mg or highest tolerated dose.
干预措施: Topiramate (Drug)
Placebo (Sugar Pill)
Placebo arm will receive matching capsules without topiramate.
干预措施: Placebo (Drug)
结局指标
主要结局
Percentage of Heavy Drinking Days
时间窗: 14 weeks
The Alcohol Timeline Follow Back (TLFB) interview was conducted to establish a baseline drinking pattern over the previous 90 days and confirm the presence of an alcohol use disorder (defined as consumption of greater than 35 standard drinks per week over the previous 4 weeks). The TLFB involves asking participants to retrospectively report their drinking days using a calendar.
次要结局
- Amount of PTSD Symptoms(14 weeks)
研究者
MPRC
Physician, Maryland Psychiatric Research Center, Outpatient Research Program
University of Maryland, Baltimore