NCT00000445已完成4 期
Effectiveness of Naltrexone in a Community Setting
National Institute on Alcohol Abuse and Alcoholism (NIAAA)2 个研究点 分布在 1 个国家目标入组 300 人开始时间: 1999年11月3日最近更新:
适应症
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 300
- 试验地点
- 2
研究概览
简要总结
This 12-week trial will compare individuals receiving naltrexone or placebo plus substance abuse counseling therapy versus those receiving only substance abuse counseling therapy in a rural, nonacademic setting. A followup period of 12 months is included. The effect on service utilization and the cost of the addition of naltrexone to treatment services for alcohol dependence also will be assessed. The study will expand existing research concerning the effectiveness of naltrexone in clinical trials versus a clinical setting.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Meets criteria for alcohol dependence (within the past 3 months).
- •Meets criteria for another substance use disorder (except narcotic dependence) but must identify alcohol as the primary substance of abuse.
- •Must be able to provide an informed consent.
- •Consent to random assignment and be willing to commit to possible medication treatment and research follow-up.
- •Must be eligible for treatment at the Dorchester Alcohol and Drug Commission.
排除标准
- •Meets criteria for opiate dependence.
- •Clinically significant medical problems such as collagen-vascular disease, cardiovascular, renal, gastrointestinal or endocrine problem that would impair participation or limit medication ingestion.
- •Hepatocellular disease.
- •Women who are pregnant, nursing, or not practicing an effective means of birth control.
- •Currently being prescribed naltrexone.
- •Known sensitivity or allergy to naltrexone.
研究者
研究点 (2)
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