ISRCTN62137064已完成不适用
Examining unique pharmacology intervention for heavy drinking alcohol dependent individuals who smoke
ABMRF/The Foundation for Alcohol Research (USA)0 个研究点目标入组 30 人开始时间: 2013年10月29日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 30
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •1. Between 18 and 75 years old
- •2. DSM-IV diagnoses of both alcohol and nicotine co-dependency, with heavy use of alcohol (men = 5 Standard Drink Units [SDUs], and women = 4 SDUs a day) and cigarettes (=10 cigarettes per day) on average during the last 90 days before screening
- •3. Interested in receiving treatment for both drinking and smoking (either reducing or stopping both substances; or reducing one substance and stopping the other).
排除标准
- •1. Current (i.e. past year) DSM-IV diagnosis of dependence on any psychoactive substance other than alcohol and nicotine
- •2. Lifetime DSM-IV diagnosis of schizophrenia, bipolar disorder, or other psychosis
- •3. Past year diagnosis of major depression, anxiety disorders, eating disorders
- •4. Risk of suicide (e.g. active plan, or recent attempt in last year)
- •5. Positive urine drug screen at baseline for any illegal substance other than marijuana
- •6. Important alcohol withdrawal symptoms, as assessed by a Clinical Institute Withdrawal Assessment for Alcohol revised (CIWA-Ar) score >10
- •7. History of hospitalization for alcohol intoxication delirium, alcohol withdrawal delirium or seizure
- •8. Participation in any research study for alcoholism and/or smoking treatment within 3 months prior to signing the consent document
- •9. Pharmacological treatment with naltrexone, acamprosate, topiramate, disulfiram, nicotine replacement, bupropion, varenicline within 1 month prior to randomization
- •10. Current use of psychotropic medications or medications that interfere with the metabolism of BACL, history of allergy to BACL or medical contraindications to take BACL
- •11. Severe medical diseases, such as cancer, cirrhosis, chronic kidney failure, chronic neurological disorders
- •12. Females who were of child bearing potential and not practicing effective birth control.
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