NCT01135602Unknown4 期
Topiramate for Hospitalized Patients With Alcoholism: a 12-Week Open-Label Study
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- Cognition
研究概览
简要总结
12-week, open-label study of topiramate in hospitalized patients with alcoholism
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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 problems
- •DSM-IV-TR alcohol dependence
- •>/= 35 drinks/week (male) or >/= 28 drinks/week (female) for >/= 1 week during four weeks prior to the admission
- •AUDIT score >/= 8
- •Mild or no alcohol withdrawal
- •Body mass index > 18 kg/m2
- •No pregnancy and no plan for pregnancy (female)
- •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, systematic steroids, carbonic anhydrase inhibitors, hydrochlorthiazide, metformin, pioglitazone, or disulfiram
- •Moderate to high risk of suicide
- •Medical history of narrow angle glaucoma, renal impairment, kidney stones, and seizures
- •Unstable medical conditions
- •Plan to receive a formal treatment for alcoholism from other treatment settings
- •Under legal process
- •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
1 group
干预措施: Topiramate (Drug)
结局指标
主要结局
Cognition
时间窗: 12 weeks
Cognition will be assessed by the use of Montreal Cognitive Assessment (MoCA)
次要结局
- Alcohol drink/day(12 weeks)
研究者
研究点 (1)
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