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

Ryan D. McDonald, Babak Tofighi, Eugene Laska, Keith Goldfeld, Wanda Bonilla, Mara Flannery, Nadina Santana-Correa, Christopher W. Johnson, Neil Leibowitz, John Rotrosen, Marc Gourevitch, Joshua Lee

Research output: Contribution to journalArticle

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.

Original languageEnglish (US)
Pages (from-to)57-64
Number of pages8
JournalContemporary Clinical Trials
Volume49
DOIs
StatePublished - Jul 1 2016

Fingerprint

Naltrexone
Opioid Analgesics
Methadone
Standard of Care
Secondary Prevention
Therapeutics
Recurrence
Injections
Narcotic Antagonists
mu Opioid Receptor
Prisons
Heroin
Risk-Taking
Cocaine
Sexual Behavior
Counseling
Randomized Controlled Trials
Alcohols
Outcome Assessment (Health Care)
HIV

Keywords

  • Criminal justice
  • Extended-release naltrexone
  • Jail
  • Naltrexone
  • Opioid relapse prevention

ASJC Scopus subject areas

  • Medicine(all)
  • Pharmacology (medical)

Cite this

McDonald, R. D., Tofighi, B., Laska, E., Goldfeld, K., Bonilla, W., Flannery, M., ... Lee, J. (2016). Extended-release naltrexone opioid treatment at jail reentry (XOR). Contemporary Clinical Trials, 49, 57-64. https://doi.org/10.1016/j.cct.2016.05.002

Extended-release naltrexone opioid treatment at jail reentry (XOR). / 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; Lee, Joshua.

In: Contemporary Clinical Trials, Vol. 49, 01.07.2016, p. 57-64.

Research output: Contribution to journalArticle

McDonald, RD, Tofighi, B, Laska, E, Goldfeld, K, Bonilla, W, Flannery, M, Santana-Correa, N, Johnson, CW, Leibowitz, N, Rotrosen, J, Gourevitch, M & Lee, J 2016, 'Extended-release naltrexone opioid treatment at jail reentry (XOR)', Contemporary Clinical Trials, vol. 49, pp. 57-64. https://doi.org/10.1016/j.cct.2016.05.002
McDonald RD, Tofighi B, Laska E, Goldfeld K, Bonilla W, Flannery M et al. Extended-release naltrexone opioid treatment at jail reentry (XOR). Contemporary Clinical Trials. 2016 Jul 1;49:57-64. https://doi.org/10.1016/j.cct.2016.05.002
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 ; Lee, Joshua. / Extended-release naltrexone opioid treatment at jail reentry (XOR). In: Contemporary Clinical Trials. 2016 ; Vol. 49. pp. 57-64.
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