NCT00000451已完成2 期
Naltrexone and SSRI Therapy for Alcohol Dependence in Alaska Natives
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 198
- 主要终点
- Days abstinent
研究概览
简要总结
This study will assess the ability of naltrexone (Revia) to reduce the risk of relapse in Alaska natives with alcohol dependence. The study will also examine whether a combination of naltrexone and sertraline (Zoloft) yields better abstinence rates than naltrexone used alone. Alaska Native individuals will be recruited into a 16 week outpatient study.
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
- Triple (Participant, Care Provider, Investigator)
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
- •Alaska Native having biological Alaska Native ancestry.
- •Meets criteria for alcohol dependence.
- •Prior to entering the study must be abstinent between 3 and 14 days and have a withdrawal assessment.
- •Stable residence to ensure that subjects can be located during the study.
排除标准
- •Currently meets criteria for abuse or dependence on substances other than alcohol or nicotine.
- •Current use of disulfiram.
- •Psychotic or otherwise severely psychiatrically disabled.
- •Use of other psychotropic medications including antidepressants and anxiolytics.
- •Medical conditions that would not permit the use of sertraline or naltrexone, such as a history of unstable or severe hepatic, cardiovascular, metabolic, endocrine, gastrointestinal or kidney disease.
- •Hepatocellular disease or elevated bilirubin levels.
- •Females who are pregnant, nursing, or not using a reliable method of birth control.
- •Probation or parole requirements that might interfere with participation in the study.
- •Involvement in alcohol treatment other than provided by the study or AA.
- •Use of monoamine oxidase inhibitors in the past month.
- •Current use of Type 1C antiarrhythmics propafenone and flecainide.
研究组 & 干预措施
1
Experimental
Naltrexone plus Sertraline
干预措施: naltrexone (Drug)
2
Experimental
Naltrexone alone
干预措施: sertraline (Drug)
2
Experimental
Naltrexone alone
干预措施: naltrexone (Drug)
结局指标
主要结局
Days abstinent
次要结局
未报告次要终点
研究者
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