Alcohol Pharmacotherapy for HIV+ Prisoners With Alcohol Dependence and Problem Drinking
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Percentage of Those Maintain or Improve to HIV RNA-1 Viral Load Less Then 400 Copies/mL
研究概览
简要总结
This is a randomized controlled trial of injectable intramuscular naltrexone (XR-NTX) versus intramuscular placebo among HIV-infected prisoners meeting Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV) criteria for alcohol dependence or problem drinking, who are transitioning to the community and seeking treatment to prevent relapse to alcohol use. We hypothesize that extended release naltrexone (XR-NTX) will result in improved HIV outcomes (lower log10 HIV-1RNA levels and higher CD4 count) as well as improved alcohol treatment outcomes, and reduced drug/sex HIV related risk behaviors and decreased rates of reincarceration.
详细描述
INSPIRE is a randomized controlled trial of injectable intramuscular NTX (XR-NTX) versus intramuscular placebo among Human Immunodeficiency (HIV) infected prisoners meeting DSM-IV criteria for alcohol dependence or problem drinking, who are transitioning to the community and seeking treatment to prevent relapse to alcohol use. While the COMBINE trial has demonstrated the effectiveness of oral naltrexone in a group of active alcohol dependent persons in decreasing relapse to alcohol use over placebo, naltrexone has not been studied in people who have a history of current alcohol dependence prior to incarceration, are incarcerated and not actively using alcohol and are likely to return to alcohol use when released. In this study, we conduct a placebo-controlled trial to determine if naltrexone has an effect in this group, which could be important in making the case for having naltrexone available to alcohol dependent or problem drinking HIV+ prisoners prior to release. We will compare their HIV treatment (HIV-1 RNA levels, CD4 count), alcohol treatment (time to relapse to heavy drinking, percent of days drinking, percent of days abstinent and alcohol craving) and HIV risk behavior (sexual and drug-related risks) outcomes. The hypotheses include:
i. XR-NTX will result in improved HIV clinical outcomes, including changes in HIV-1 RNA levels, and higher CD4 counts.
ii. XR-NTX will result in improved alcohol treatment outcomes, including longer time to alcohol relapse, lower percent days drinking, and lower craving for alcohol.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •Inmates returning to New Haven or Hartford
- •Meets criteria for alcohol dependence (using Diagnostic and Statistical Manual IV) or problem drinking (using Alcohol Use Disorder Identification Test-AUDIT)
- •Gives informed consent
- •English or Spanish speaker
排除标准
- •On opiate pain medication or expressing need for them
- •Aspartate aminotransferase (AST) and Alanine aminotransferase (ALT) > 5x the upper limit of normal
- •Evidence of Child's Pugh Class C cirrhosis
- •Pending felony charges
- •Pregnant or unwilling to take contraceptive measures
- •Subject is part of another pharmacological research study
研究组 & 干预措施
Intramuscular naltrexone
Subjects in this arm will receive monthly intramuscular gluteal injections of depot naltrexone 380mg (VIVITROL) for 6 months. The 1st injection will be administered prior to release from prison or jail.
干预措施: Vivitrol- Intramuscular naltrexone (depot-formulation) (Drug)
Placebo
Subjects in this arm will receive monthly intramuscular gluteal injections of placebo for 6 months. The 1st injection will be administered prior to release from prison or jail.
干预措施: Placebo (Drug)
结局指标
主要结局
Percentage of Those Maintain or Improve to HIV RNA-1 Viral Load Less Then 400 Copies/mL
时间窗: Baseline to month 6 post release
Percentage of participants that maintained or improved a level of undetectable HIV viral load from baseline (closest viral load to time of release from incarceration) to 6 months post release. Missing lab values were considered to have a detectable HIV viral load.
次要结局
- Alcohol Treatment Outcome: Time to Alcohol Relapse(Post release)
- Alcohol Treatment Outcome: Change in Average Drinks Per Drinking Day(12 weeks prior to release from prison (baseline) to 6 months post release)
- Alcohol Treatment Outcome: Change in Percent of Heavy Drinking Days(change in percent of heavy drinking days12 weeks prior to release from prison (baseline), day of release, to 6 months post-release)