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.

Public Health Relevance

This study addresses the large population of opioid-addicted persons, including a disproportionate number of HIV and Hepatitis C (HCV) infected individuals, cycling in and out of US jails and not accessing evidence-based medical treatment for opioid dependence or HIV/HCV risk reduction, including a new, long-acting medication, extended-release naltrexone (XR-NTX). We seek to evaluate the effectiveness of XR-NTX in a large urban jail setting, enrolling otherwise out-of-treatment individuals just as they leave jail and return to the community, when they are at high risk for relapse to heroin and illicit opioids and HIV/HCV risk behaviors, including drug injection and unsafe sex. In addition, we seek to compare participants receiving XR-NTX to those receiving methadone maintenance at jail release in order to compare XR-NTX to the current standard-of-care.

National Institute of Health (NIH)
National Institute on Drug Abuse (NIDA)
Research Project--Cooperative Agreements (U01)
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Risk, Prevention and Intervention for Addictions Study Section (RPIA)
Program Officer
Wiley, Tisha R A
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New York University
Internal Medicine/Medicine
Schools of Medicine
New York
United States
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Farabee, David; Hillhouse, Maureen; Condon, Timothy et al. (2016) Injectable pharmacotherapy for opioid use disorders (IPOD). Contemp Clin Trials 49:70-7
Chandler, Redonna K; Finger, Matthew S; Farabee, David et al. (2016) The SOMATICS collaborative: Introduction to a National Institute on Drug Abuse cooperative study of pharmacotherapy for opioid treatment in criminal justice settings. Contemp Clin Trials 48:166-72
McDonald, Ryan D; Tofighi, Babak; Laska, Eugene et al. (2016) Extended-release naltrexone opioid treatment at jail reentry (XOR). Contemp Clin Trials 49:57-64