Extended-Release Naltrexone Opioid Treatment at Jail-to-Community Re-entry

这项研究旨在评估新FDA批准的缓释纳洛酮（XR-NTX）在离开大型城市监狱的阿片类药物依赖参与者中预防阿片类药物复发的有效性。 虽然美沙酮治疗在纽约市监狱中可用，但许多海洛因和其他阿片类药物使用者，包括艾滋病毒和丙型肝炎（HCV）感染者，在被捕时拒绝接受这种治疗，而是离开监狱治疗，并处于极高的风险立即阿片类药物复发，致命的过量和艾滋病毒/HCV相关的不良后果，包括恢复注射毒品使用和不安全性行为的模式。 XR-NTX是一种无滥用潜力的可注射非麻醉性阿片类拮抗剂，可阻断海洛因和其他阿片类药物的常见生理作用长达4周，为不选择激动剂药物的个体提供了一种新的药物治疗选择。 我们提出了一项XR-NTX与增强治疗的随机试验，以确定XR-NTX作为阿片类药物复发和HIV/HCV风险预防的有效性。此外，一个重要的问题是XR-NTX与美沙酮维持标准治疗相比如何，本研究将招募一个额外的、非随机的、准实验性美沙酮队列，以比较有效性。

This study seeks to estimate the effectiveness of newly FDA-approved extended-release naltrexone (XR-NTX) for opioid relapse prevention among opioid dependent participants leaving a large urban jail. While methadone treatment is available in NYC jails, many heroin and other opioid users, including HIV and Hepatitis C (HCV) infected individuals, decline this treatment at arrest, and instead leave jail out-of-treatment and at extraordinarily high risk for immediate opioid relapse, fatal overdose, and HIV/HCV-related adverse outcomes, including resuming patterns of injection drug use and unsafe sex. XR-NTX, an injectable non-narcotic opioid antagonist with no abuse potential, which blocks the usual physiologic effects of heroin and other opioids for up to 4 weeks, constitutes a new pharmacotherapy option for individuals not opting for agonist medications. We propose a randomized trial of XR-NTX versus enhanced treatment-as-usual to establish XR-NTX¿s effectiveness as re-entry opioid relapse and HIV/HCV risk prevention. Further, an important question is how XR-NTX compares to methadone maintenance standard-of-care, and this study will recruit an additional, non-randomized, quasi-experimental methadone cohort for comparative effectiveness purposes.