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

本研究旨在评估fda新批准的缓释纳曲酮（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。虽然纽约市的监狱可以提供美沙酮治疗，但许多海洛因和其他阿片类药物使用者，包括感染艾滋病毒和丙型肝炎（HCV）的人，在被捕时拒绝接受这种治疗，而是离开监狱后得不到治疗，并且面临着立即发生阿片类药物复发、致命过量和与艾滋病毒/丙型肝炎相关的不良后果的极高风险，包括恢复注射吸毒和不安全性行为的模式。XR-NTX是一种可注射的非麻醉性阿片类拮抗剂，没有滥用的可能性，可阻断海洛因和其他阿片类药物通常的生理作用长达4周，对于不选择激动剂药物的个人来说，这是一种新的药物治疗选择。我们建议进行XR-NTX与常规强化治疗的随机试验，以确定XR-NTX在阿片类药物复发和HIV/HCV风险预防方面的有效性。此外，一个重要的问题是XR-NTX与美沙酮维持标准护理的比较，本研究将招募一个额外的、非随机的、准实验的美沙酮队列，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.