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Extended-release naltrexone opioid treatment at jail re-entry (XOR).

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McDonald RD, Tofighi B, Laska E, Goldfeld K, Bonilla W, Flannery M, Santana-Correa N, Johnson CW, Leibowitz N, Rotrosen J, Gourevitch MN, Lee JD,


McDonald RD, Tofighi B, Laska E, Goldfeld K, Bonilla W, Flannery M, Santana-Correa N, Johnson CW, Leibowitz N, Rotrosen J, Gourevitch MN, Lee JD, (click to view)

McDonald RD, Tofighi B, Laska E, Goldfeld K, Bonilla W, Flannery M, Santana-Correa N, Johnson CW, Leibowitz N, Rotrosen J, Gourevitch MN, Lee JD,

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Contemporary clinical trials 2016 5 10() pii 10.1016/j.cct.2016.05.002

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.

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