Acamprosate and Integrative Behavior Therapy in the Outpatient Treatment of Alcohol Dependents
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 371
- 试验地点
- 1
- 主要终点
- Abstinence
研究概览
简要总结
The main aim of this project consists in the investigation of the interaction of behavior therapy and Acamprosate in the outpatient treatment of alcoholic patients in a randomized, prospective and (regarding study medication Acamprosate vs. Placebo) double blind design. A total of 371 patients has been randomly assigned immediately after detoxification to one of three different outpatient treat-ment conditions.
详细描述
The objective of this multi-center study is to optimize the long-term treatment of patients with alcohol dependence. This investigation should contribute to the issue of effective relapse prevention. Each treatment condition is lasting 6 months: a) Behavior Group Therapy + Acamprosate, b) Behavior Group Therapy + Placebo and c) support and counseling + Acamprosate. Follow-up examinations carried out 3 and 6 months after the end of treatment.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 25 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •DSMIV criteria of alcoholism
- •Age between 25 and 60
- •Informed consent
排除标准
- •Residence outside of the catchment area
- •Legal reasons
- •Insufficient knowledge of the German language
- •Substance abuse or addiction other than alcohol or nicotine
- •Pregnancy
- •Serious physical illness
- •Organic brain disease
- •Contraindication to Acamprosate treatment
研究组 & 干预措施
2
Placebo +Integrative behavior therapy
干预措施: Integrative behavior therapy (Behavioral)
2
Placebo +Integrative behavior therapy
干预措施: Placebo (Drug)
3
Acamprosate + treatment as usual
干预措施: Acamprosate (Drug)
1
Acamprosate + Integrative behavior therapy
干预措施: Acamprosate (Drug)
1
Acamprosate + Integrative behavior therapy
干预措施: Integrative behavior therapy (Behavioral)
结局指标
主要结局
Abstinence
时间窗: 3,6,12 months
次要结局
- Social functioning(12 months)
- Cognitive functioning(12 months)