Phase Four Randomized, Multicentre, Open-Label, Comparative Trial Of Disulfiram, Nalterexone And Acamprosate In The Treatment Of Alcohol Dependence
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 243
- 试验地点
- 2
- 主要终点
- Time(days) to first heavy drinking (HDD)day after medication started
研究概览
简要总结
The aim of this study was to compare the effect of manual based cognitive therapy in adjunct of three different pharmacotherapy.
详细描述
Context Alcoholism is common clinical problem and its treatment has no standard and is controversy. Different pharmacotherapy's, acamporsate, nalterxone and disulfiram have shown to improve the drinking outcomes, but there is no randomized comparative studies on the effects of these three medications.
Objectives The aim of this study was to compare the effect of manual based cognitive therapy in adjunct of three different pharmacotherapy.
Design and setting Randomized, open label, multicentre naturalistic study, 12 week continuous medication followed by targeted medication up to 52weeks and 67 week follow up on voluntary treatment seeking alcohol dependent outpatients.
Participants 243 alcohol dependent adults. Intervention Subjects were randomized 1:1:1 to receive naltrexone, acamprosate or disulfiram, 50 mg, 1998 mg or 200 mg correspondingly per day. The patients were met weekly in first month, then after 3, 6 and 12 months.
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
- None
入排标准
- 年龄范围
- 25 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Alcohol dependence (ICD-10)
排除标准
- •Clinically significant symptoms of alcohol withdrawal
- •Significant recently diagnosed psychiatric disease (psychosis, personality disorder or suicidal tendency that appeared during the initial interview)
- •Current psychiatric disease demanding special treatment or medication including DSM-IV determined drug dependence other than alcohol or nicotine dependence
- •Current use of any opioids within four weeks before screening
- •Significant brain, thyroid, kidney, uncompensated heart disease, or clinically significant liver disease (cirrhosis, aqlcoholic hepatitis or ALAT > 200)
- •Pregnancy, nursing, or women refused to use a reliable method for birth control
结局指标
主要结局
Time(days) to first heavy drinking (HDD)day after medication started
次要结局
- Time (days) to first drinking after medication started
- Abstinence days (0 drinks/ day) by group
- Average alcohol intake (weekly by group)
- ALAT
- GGT
- SADD
- AUDIT
- EQ-5