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

Abstract

Background 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. Methods 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. Results 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. Conclusions 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.

The SOMATICS collaborative: Introduction to a National Institute on Drug Abuse cooperative study of pharmacotherapy for opioid treatment in criminal justice settings

“…More information on sample size calculations and effect size can be found at McDonald, et al, Extended-Release Naltrexone Opioid Treatment at Jail-Reentry ( XOR ) [13]; Farabee, Injectable Pharmacotherapy for Opioid Use Disorder ( IPOD ) [14]; and Schwartz, Interim Methadone and Patient Navigation in Jail : Rationale and Design of a Randomized Clinical Effectiveness Trial [15]. …”

“…Site 1: New York School of Medicine and Bellevue Hospital Center working in New York City Department of Corrections facilities on Rikers Island (New York, NY); Site 2: University of California Los Angeles in collaboration with Bernalillo County Metropolitan Detention Center and the University of New Mexico (Los Angeles, CA; Albuquerque, NM); Site 3: Friends Research Institute in collaboration with Maryland Division of Pretrial and Detention Services (Baltimore, MD). For detailed descriptions of each site/study’s methodology, see McDonald et al, Extended-Release Naltrexone Opioid Treatment at Jail Reentry ( X : OR ) [13]; Farabee et al, Injectable Pharmacotherapy for Opioid Use Disorders ( IPOD ) [14]; and Schwartz et al, Interim Methadone and Patient Navigation in Jail : Rationale and Design of a Randomized Clinical Effectiveness Trial [15]. …”

“…Follow-up interviews are entered directly into a web-based data entry system supported through the Research Electronic Data Capture (RED-Cap) system [6]. Specific information on the collection of follow-up data can be found in McDonald, Farabee and Schwartz [13–15]. …”

“…PN will be tested as an adjunct to XR-NTX at RC 2 [14] and an adjunct to interim methadone at RC 3 [15]. One SOMATICS site (RC 1) will not use PN [13]. …”

Initiating methadone in jail and in the community: Patient differences and implications of methadone treatment for reducing arrests

“…There is now in progress a National Institute on Drug Abuse-funded cooperative study consisting of three linked randomized trials of initiating medication treatment for opioid use disorder in jails. Two of these studies are examining extended-release naltrexone in jails in Albuquerque, NM (Farabee et al, 2016) and New York City, (McDonald et al, 2016) while the third is examining methadone in Baltimore, MD (Schwartz et al, 2016). All three studies include a non-medication control condition.…”