NCT00000438已完成4 期
Naltrexone Treatment for Alcoholism: Predicting Outcome
适应症
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 192
- 试验地点
- 2
研究概览
简要总结
This study will evaluate the effectiveness of the medication naltrexone (Revia) for treating alcoholism. Individuals will be inpatients for a 2 week period and provide assessments of their alcohol withdrawal symptoms, craving, and mood. Following hospital discharge, individuals will be assigned randomly to receive naltrexone daily, naltrexone twice a day or a placebo. This part of the study will last 12 weeks, with regular measurements of drinking level, craving and mood. Assessments will be conducted 6 and 12 months after the beginning of the study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 主要目的
- Treatment
入排标准
- 年龄范围
- 30 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Meets criteria for alcohol dependence.
- •Committed to alcohol abstinence as a treatment goal.
- •Individuals will be required to identify two family members or close friends who are knowledgeable about their location, drinking behavior, and psychosocial status.
排除标准
- •Meets criteria for any other psychoactive substance use disorder (excluding nicotine and caffeine).
- •Meets criteria for a major psychiatric disorder and are in need of or currently undergoing pharmacotherapy.
- •Females who are pregnant, lactating, or not using a reliable method of contraception.
- •Currently experiencing a serious medical condition that would place them at risk or interfere with study participation.
- •Experiencing acute hepatitis or liver failure or whose liver function test is more than 3 times normal.
- •Have a history of severe allergies, multiple adverse drug reactions or known allergy to naltrexone.
- •Vocabulary below the 5th grade reading level.
- •Abnormal MRI scan.
- •HIV infection due to the neurological sequelae.
- •Significant central nervous system diseases.
- •Seizure disorder or history of closed head trauma.
- •Neuroendocrine disorders.
- •Treatment with opiates within the last six months.
研究者
研究点 (2)
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