Extended-release naltrexone opioid treatment at jail reentry (XOR)

• Published in: Contemporary clinical trials 2016-07, Vol.49, p.57-64
• Main Authors: McDonald, Ryan D., Tofighi, Babak, Laska, Eugene, Goldfeld, Keith, Bonilla, Wanda, Flannery, Mara, Santana-Correa, Nadina, Johnson, Christopher W., Leibowitz, Neil, Rotrosen, John, Gourevitch, Marc N., Lee, Joshua D.
• Format: Article
• Language: English
• Subjects: Analgesics, Opioid - therapeutic use; Cause of Death; Criminal justice; Delayed-Action Preparations; Drug Overdose - prevention & control; Extended-release naltrexone; Humans; Injections, Intramuscular; Jail; Methadone - therapeutic use; Mortality; Naltrexone; Naltrexone - therapeutic use; Narcotic Antagonists - therapeutic use; Opiate Substitution Treatment; Opioid relapse prevention; Opioid-Related Disorders - drug therapy; Opioid-Related Disorders - rehabilitation; Patient Participation; Prisons; Secondary Prevention
• ISSN: 1551-7144; 1559-2030
• DOI: 10.1016/j.cct.2016.05.002

Extended-release naltrexone (XR-NTX) is an injectable monthly sustained-release mu opioid receptor antagonist, which blocks the typical effects of heroin and other opioid agonists. Use of XR-NTX among opioid dependent persons leaving jails and prisons is increasing despite scant high-quality evidence regarding XR-NTX's effectiveness at re-entry. This 24-week, open-label randomized controlled trial examines the effectiveness of XR-NTX as opioid relapse prevention at release from jail (N=85) compared to enhanced treatment as usual (ETAU, N=85). A third, non-randomized, quasi-experimental naturalistic arm of participants who have newly initiated a jail-to-community methadone treatment program (MTP, N=85) allows for comparisons to a methadone standard-of-care. We describe the rationale, design, and primary and secondary outcomes of the study. The primary outcome is an opioid relapse event; the primary contrast is a time-to-relapse comparison of XR-NTX and ETAU over a 24-week treatment phase. Secondary outcomes are rates of: (a) post-release opioid treatment participation, (b) opioid, alcohol, and cocaine use, (c) injection drug use and HIV sexual risk behaviors, (d) overdose (fatal and non-fatal) and all-cause mortality, and, (e) re-incarceration. XR-NTX is a potentially important, effective treatment and relapse prevention option for a large US population of persons with opioid use disorders leaving jails. This study will estimate XR-NTX's effectiveness relative to existing standards of care, including counseling-only treatment-as-usual and methadone maintenance.