This study seeks to estimate the effectiveness of newly FDA-approved extended- release naltrexone (XR-NTX) when initiated by opioid users leaving a larger urban jail. This study targets persons who have explicitly rejected methadone maintenance re-entry treatment, and are instead expected to leave jail out-of-treatment and at extraordinarily high risk for immediate opioid relapse and fatal accidental overdose, among other relapse-related adverse outcomes. XR-NTX in this case stands as an additional, `salvage' pharmacotherapy option among persons resistant to agonist medications, and we propose a randomized trial of XR-NTX versus enhanced `drug-free' treatment-as- usual to establish XR-NTX's effectiveness as re-entry relapse prevention. Further, an important question is also how XR-NTX would compare to jail methadone usual care, and this study will recruit an additional, non-randomized, quasi-experimental methadone cohort for comparative effectiveness purposes.
This study addresses the large population of opioid-addicted persons cycling in and out of US jails and not accessing evidence-based medical treatment for opioid dependence, including a new, long-acting medication, extended-release naltrexone (XR- NTX). We seek to evaluate the effectiveness of this new medication in a large urban jail setting, enrolling otherwise out-of-treatment persons just as they leave jail and return to their communities, when they are at high risk for relapse to heroin and other illicit opioid use. In addition, we seek to compare patients receiving extended-release naltrexone to others receiving methadone maintenance in jail in a non-randomized, quasi- experimental observational design, in order to compare the XR-NTX to the current standard-of-care.
| 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 |
| 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 |
