NCT01145677已完成2 期
Efficacy of Topiramate for Hospitalized Patients With Alcoholism: a 12-Week Randomized, Placebo-Controlled Trial
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 90
- 试验地点
- 3
- 主要终点
- Alcohol drink/day
研究概览
简要总结
This is a 12-Week, randomized controlled study of topiramate in hospitalized patients with alcoholism
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 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients hospitalized due to alcohol-related problem
- •DSM-IV-TR alcohol dependence
- •for male: history of alcohol drink >=35/week, female: history of alcohol drink >=28/week for at least 1 week during four weeks prior to the admission
- •AUDIT score at least 8
- •mild or no alcohol withdrawal symptom
- •BMI > 18 kg/m2
- •not pregnant and no plan for pregnancy
- •intention to decrease or stop drinking
排除标准
- •severe psychiatric and cognitive disorders
- •other substance dependence, except nicotine and caffeine dependence, during 6 months prior to enrollment
- •taking antipsychotics, mood stabilizers, anticonvulsants, opioid analgesics, systemic steroids, carbonic anhydrase inhibitors, hydrochlorthiazide, metformin, pioglitazone, or disulfiram
- •unstable medical condition
- •medical history of narrow angle glaucoma, renal impairment, kidney stones, and seizures
- •moderate to high risk of suicide
- •under legal process
- •plan to receive a formal treatment for alcoholism from other treatment settings
- •pregnancy and nursing woman
- •abnormal laboratory tests, including blood urea nitrogen, creatinine, electrolytes, and fasting blood sugar
研究组 & 干预措施
Topiramate
Experimental
干预措施: Topiramate (Drug)
结局指标
主要结局
Alcohol drink/day
时间窗: 12 weeks
Alcohol drink/day assessed by the use of time line follow back
次要结局
- Common adverse effect(12 week)
研究者
研究点 (3)
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