Oral Naltrexone for Improved Medication Compliance Among HIV-infected Men With Alcohol Use Disorder
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 159
- 试验地点
- 1
- 主要终点
- HIV Viral Load Suppression
研究概览
简要总结
This study will recruit 159 HIV-infected men with alcohol use disorders (AUDs). Men will be randomized to receive either oral naltrexone for the treatment of alcohol use disorder or placebo. Men with acute, recent or established HIV infection will receive antiretroviral treatment (ART) and be randomized to oral naltrexone or placebo. The purpose of this study is to see whether use of oral naltrexone improves medication compliance, and therefore HIV viral load suppression, among men with alcohol use disorder. The study will also assess the impact of oral naltrexone on alcohol use behaviors in this population.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Meets DSM-IV criteria for alcohol dependence or problem drinking.
- •Age 18 years and older
- •Confirmed HIV infection, either through positive HIV antibody or detectable HIV-1 RNA level.
- •No participation in pharmacotherapy trial in the previous 30 days
- •Not pregnant
排除标准
- •Unable to provide informed consent
- •Verbally or physically threatening to research staff
- •Unable to communicate in Spanish
- •Pending trials for a felony
- •Childs-Pugh Class C Cirrhosis
- •Grade 3 Hepatitis (LFTs > 5X normal)
- •Receiving opioid prescription narcotics or has pain syndrome necessitating future use of opioid prescription narcotics.
研究组 & 干预措施
Placebo pill
Daily oral placebo.
干预措施: Placebo pill (Drug)
NTX
Daily oral naltrexone.
干预措施: oral naltrexone (Drug)
结局指标
主要结局
HIV Viral Load Suppression
时间窗: 6 months
The primary outcome will be the proportion with a VL\<400 copies/mL at 6 months.
次要结局
- ART Compliance and Alcohol Use Behavior(6 months)
研究者
Ann C Duerr
Member
Fred Hutchinson Cancer Center