NCT00000450已完成4 期
Nalmefene Maintenance Treatment of Alcoholism
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 159
- 试验地点
- 1
研究概览
简要总结
The purpose of this study is to determine the long-term effectiveness of naltrexone treatment in alcohol-dependent patients who respond to short-term treatment. Those who respond to short-term treatment will be randomized to a 1-year, double-blind, placebo-controlled maintenance phase with a 6-month posttreatment followup.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
Naltrexone and placebo were identical in appearance and packaging to preserve the double blind.
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.
- •Expresses a desire to cut down or stop drinking.
排除标准
- •Currently meets criteria for dependence on substances other than alcohol.
- •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.
- •Female patients who are pregnant, nursing, or not using a reliable method of birth control.
- •Inability to understand and provide a consent form.
- •Treatment with an investigational drug during the previous month.
- •Prior treatment with naltrexone.
- •Chronic treatment with any narcotic-containing medications during the previous month.
- •Sensitivity to naltrexone as evidenced by adverse drug experiences especially with narcotic containing analgesics or opioid antagonists.
- •Current treatment with disulfiram.
- •More than 6 weeks of abstinence.
- •Meets criteria for a major psychiatric disorder and is in need of, or currently undergoing pharmacotherapy.
研究组 & 干预措施
Naltrexone Tablet
Active Comparator
干预措施: Naltrexone Tablet (Drug)
Matched Placebo Tablet
Placebo Comparator
干预措施: Matched Placebo Tablet (Drug)
研究者
Barbara J. Mason
Principal Investigator
The Scripps Research Institute
研究点 (1)
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