Topiramate Treatment of Hazardous and Harmful Alcohol Use in Veterans With TBI
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 32
- 试验地点
- 1
- 主要终点
- Change in the Number of Drinking Days Per Week as Assessed by the Timeline Followback (TLFB)
研究概览
简要总结
The goal of the proposed project is to improve the treatment of veterans with co-occurring traumatic brain injury (TBI) and hazardous or harmful alcohol use. The PI and coinvestigators will conduct a pilot controlled clinical trial of topiramate for the treatment of these co-occurring disorders.
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
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Topiramate
Topiramate capsules daily - up to 300 mg
干预措施: Medical Management Counseling (Behavioral)
Topiramate
Topiramate capsules daily - up to 300 mg
干预措施: Topiramate (Drug)
Placebo
Placebo capsules daily - up 300 mg
干预措施: Medical Management Counseling (Behavioral)
Placebo
Placebo capsules daily - up 300 mg
干预措施: Placebo (Drug)
结局指标
主要结局
Change in the Number of Drinking Days Per Week as Assessed by the Timeline Followback (TLFB)
时间窗: Baseline to Week 12
Using a calendar, participants provide retrospective estimates of daily drinking over a specified period.
次要结局
- Change in TBI Symptom Severity as Assessed by the Neurobehavioral Symptom Inventory (NSI)(Baseline to Week 12)