Nalmefene in Nicotine and Alcohol Dependence
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 1
研究概览
简要总结
The purpose of this study is to determine the effectiveness of naltrexone (Revia) or matched placebo combined with nicotine patch (Nicotrol) or placebo patch using a 2x2 design in reducing drinking and smoking in patients with both nicotine and alcohol dependence.
详细描述
Eligible individuals will be randomly assigned to a 12-week trial of a fixed daily dose of either naltrexone (Revia) and nicotine replacement patch or placebos. All individuals will receive weekly coping skills and smoking-cessation behavioral therapy. Followup interviews will be conducted 3 and 6 months after treatment to determine smoking and drinking status and persistence of any dependence symptoms.
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)
盲法说明
Double blind tablet and patch active study medications, and matched tablet and patch placebos
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Meets criteria for alcohol dependence and nicotine dependence.
- •Expresses a desire to cut down or stop drinking and smoking.
排除标准
- •Currently meets criteria for dependence on substances other than alcohol and nicotine.
- •Any history of opiate dependence or evidence of current opiate use.
- •Significant medical disorders that will increase potential risk or interfere with study participation.
- •Liver function tests more than 3 times normal or elevated bilirubin.
- •Females who are pregnant, nursing, or not using a reliable method of birth control.
- •Meets criteria for a major psychiatric disorder and is in need of or currently undergoing drug therapy.
- •Inability to understand and/or comply with the provisions of the protocol and consent form.
- •Treatment with an investigational drug during the previous month.
- •Chronic treatment with any narcotic-containing medications during the previous month.
- •Sensitivity to drug as evidenced by adverse drug experiences especially with narcotic- containing analgesics or opioid antagonists.
- •Current treatment with disulfiram (Antabuse) or nicotine replacement therapy.
- •More than 6 weeks of abstinence.
研究组 & 干预措施
Naltrexone Tablet and Nicotine Patch
干预措施: Naltrexone Tablet and Nicotine Patch (Drug)
Naltrexone Tablet and Placebo Patch
干预措施: Naltrexone Tablet and Placebo Patch (Drug)
Placebo Tablet and Nicotine Patch
干预措施: Placebo Tablet and Nicotine Patch (Drug)
Placebo Tablet and Placebo Patch
干预措施: Placebo Tablet and Placebo Patch (Drug)
研究者
Barbara J. Mason
Principal Investigator
The Scripps Research Institute