NCT00523133已完成2 期
Posttreatment Effects of Naltrexone
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 185
- 试验地点
- 2
- 主要终点
- Percent Days Abstinent
研究概览
简要总结
The purpose of this study was to compare the effects of two psychosocial treatments that differed in scope and intensity (Broad Spectrum Treatment and Motivational Enhancement Treatment) combined with 3 or 6 months of treatment with naltrexone on alcohol drinking behaviors in alcohol dependent patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •men and women between the ages of 21-65
- •current DSM-IV diagnosis of alcohol dependence
- •abstinent for a minimum of 3 and maximum of 21 days prior to treatment initiation
- •able to participate in an 18-month outpatient study
- •live within a one hour or less commute to Fairbanks
- •fluent in English
- •women of child-bearing potential must have a negative pregnancy test and use effective contraceptive methods.
- •score as contemplators or greater on the Readiness For Change Scale
排除标准
- •severe hepatic disease (gGGT, SGOT or other liver functions greater than 4 times normal)
- •opiate use (for any reason) in the last 14 days or a history of opioid dependence in the past year
- •pregnant or lactating females or those unwilling to use birth control
- •inability, according to the opinion of the interviewer, to follow medication instructions and safety precautions
- •comorbid substance dependence (but not abuse) diagnosis in the past 6 months, excluding nicotine or marijuana dependence
- •concomitant use of medications intended to decrease drinking (e.g. disulfiram)
- •meeting current DSM criteria for bipolar disorder, schizophrenia, bulimia/anorexia, dementia, major depression
结局指标
主要结局
Percent Days Abstinent
时间窗: 18 months
次要结局
- Percent Heavy Drinking Days(18 months)
研究者
研究点 (2)
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