Naltrexone for Opioid Dependent Released Human Immunodeficiency Virus Positive (HIV+) Criminal Justice Populations
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 151
- 试验地点
- 2
- 主要终点
- Participants Who Had Undetectable HIV-1 RNA Levels at Less Than 400 Copies/mL at Six Month
研究概览
简要总结
Specific Aim: To conduct a randomized, placebo-controlled trial of extended release-naltrexone (XR-NTX) among Human Immunodeficiency Virus (HIV) infected prisoners meeting Diagnostic Statistical Manual IV (DSM-IV) criteria for opioid dependence who are transitioning from the structure of a correctional setting to the community.
Hypotheses:
i. XR-NTX will result in improved HIV clinical outcomes, including lower changes in HIV-1 RNA levels, higher CD4 counts and higher rates of retention in care.
ii. XR-NTX will result in improved opioid treatment outcomes, including longer time to opioid relapse, lower addiction severity and lower craving for opioid.
iii. XR-NTX will result in reduced drug- and sex-related HIV risk behaviors compared to the control group.
iv. XR-NTX will result in decreased rates of reincarceration after 12 months of release to the community.
详细描述
The specific aim for this study is to conduct a placebo-controlled trail (RCT) of XR-NTX among HIV+ persons in jails and prisons meeting DSM-IV criteria for opioid dependence who are transitioning to the community. HIV treatment outcomes (HIV-1 RNA levels, CD4 count, Highly Active Antiretroviral Therapy (HAART) adherence, retention in care), substance abuse (time to relapse to opioid use, % opioid negative urines, opioid craving), adverse side effects and HIV risk behavior (sexual and drug-related risks) outcomes will be compared in 150 recruited prisoners and jail detainees in Connecticut (CT) and Massachusetts (MA) who will be randomized 2:1 to either XR-NTX or placebo. The primary outcome of interest will be the proportion with a HIV-RNA <400 copies/mL at 6 months. Secondary outcomes include mean CD4 count, antiretroviral adherence, retention on HAART and in HIV care, HIV risk behaviors, time-to-relapse to opioid use, percent opioid negative urines, retention on d-NTX and HIV quality of life. Primary and secondary outcomes will be assessed for an additional 6 months after completion of the intervention. If this placebo-controlled trial of XR-NTX among released HIV+ criminal justice system (CJS) persons with opioid dependence demonstrates efficacy and safety, it is likely to become an evidence-based intervention to intervene with this extremely marginalized population in a way that will meet Healthy People 2010's goals to increase the quality and years of life, decrease health disparities particularly among minorities, break the cycle of addiction, reduce the numbers of people within the CJS and launch a number of new and innovative trials and second generation questions for future research. As such, the individual, our health care system and society have a high likelihood to benefit. This will not only be true for strategies here in the U.S., but may have even greater application for geographic areas where the interface between opioid disorders and HIV is even greater.
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
- 是
入选标准
- •Meets DSM-IV criteria for opioid dependence
- •Age > 18 years
- •Confirmed HIV infection, either through positive HIV antibody or detectable HIV-1 RNA level.
- •Within the Connecticut Department of Corrections (CTDOC) or Hampden County Correctional Center (HCCC) and within 30 days of being released to the greater New Haven, Hartford or Springfield areas or within 30 days after release from CTDOC or HCCC.
- •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 either English or Spanish
- •Pending trials for a felony
- •Liver failure (Childs-Pugh Class B or C Cirrhosis)
- •Grade IV Hepatitis (liver function tests > 10X normal)
- •Receiving opioid prescription narcotics or has pain syndrome necessitating future use of opioid prescription narcotics.
- •Receiving active methadone or buprenorphine/naloxone for the treatment of opioid dependency
- •Active opioid withdrawal (within 3-5 days since last opioid ingestion)
- •Pregnancy or unwilling to take contraceptives measures
- •Breast-feeding
研究组 & 干预措施
Extended-Release Naltrexone
Participants will receive intramuscular (IM) injections of Naltrexone once monthly for 6 months, the first injection being prior release
干预措施: Extended-Release Naltrexone (Drug)
Placebo
Participants will receive IM injections of Placebo once monthly for 6 months, the first injection being prior release
干预措施: Extended-Release Naltrexone (Drug)
结局指标
主要结局
Participants Who Had Undetectable HIV-1 RNA Levels at Less Than 400 Copies/mL at Six Month
时间窗: 6 months
Baseline labs will be drawn while subject is in prison, one to three months prior to release. Additionally, labs will be drawn every 3 months for 1 year to monitor changes in HIV-1 RNA levels. Treatment time period was the first 6 months where the primary outcome data will be based on.
次要结局
- Particpants Who Had Undetectable HIV-1 RNA Levels at Less Than 50 Copies/mL(6 months)
- CD4 Cell Count (Cells/mL)(Baseline and 6 months)
- Time to Opioid Relapse or End of Intervention(6 months)
- Antiretroviral Therapy (ART) Adherence 100%(6 months)
- Participants With Opiate Abstinence Via By Doing Urine Toxicology Test(6 month)
- Addiction Severity(baseline, and 6 months)
- Craving for Opioids(6 months)
- Opioid Abstinence at 6 Months for Those With More Than 4 Injections(6 months)
- ART Adherence for 4 or More Injections XR-NTX Versus Placebo and 3 or Less Injections of XR-NTX(6 months)