title: Extended-release naltrexone opioid treatment at jail reentry (XOR).
abstract: 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.
authors.affiliation: Department of Population Health, New York University School of Medicine, United States.
authors.forename: Ryan D
authors.initials: RD
authors.lastname: McDonald
authors.affiliation: Department of Population Health, New York University School of Medicine, United States.
authors.forename: Babak
authors.initials: B
authors.lastname: Tofighi
authors.affiliation: Department of Psychiatry, New York University, United States.
authors.forename: Eugene
authors.initials: E
authors.lastname: Laska
authors.affiliation: Department of Population Health, New York University School of Medicine, United States.
authors.forename: Keith
authors.initials: K
authors.lastname: Goldfeld
authors.affiliation: Department of Population Health, New York University School of Medicine, United States.
authors.forename: Wanda
authors.initials: W
authors.lastname: Bonilla
authors.affiliation: Department of Population Health, New York University School of Medicine, United States.
authors.forename: Mara
authors.initials: M
authors.lastname: Flannery
authors.affiliation: Department of Population Health, New York University School of Medicine, United States.
authors.forename: Nadina
authors.initials: N
authors.lastname: Santana-Correa
authors.affiliation: New York City Health+Hospital Corporation, Correctional Health Services, United States.
authors.forename: Christopher W
authors.initials: CW
authors.lastname: Johnson
authors.affiliation: New York City Health+Hospital Corporation, Correctional Health Services, United States.
authors.forename: Neil
authors.initials: N
authors.lastname: Leibowitz
authors.affiliation: Department of Psychiatry, New York University, United States.
authors.forename: John
authors.initials: J
authors.lastname: Rotrosen
authors.affiliation: Department of Population Health, New York University School of Medicine, United States.
authors.forename: Marc N
authors.initials: MN
authors.lastname: Gourevitch
authors.affiliation: Department of Population Health, New York University School of Medicine, United States; Division of General Internal Medicine and Clinical Innovation, New York University School of Medicine, United States. Electronic address: joshua.lee@med.nyu.edu.
authors.forename: Joshua D
authors.initials: JD
authors.lastname: Lee
mesh_terms: D000701:Analgesics, Opioid / Q000627:therapeutic use; D002423:Cause of Death; D003692:Delayed-Action Preparations; D062787:Drug Overdose / Q000517:prevention & control; D006801:Humans; D007273:Injections, Intramuscular; D008691:Methadone / Q000627:therapeutic use; D009026:Mortality; D009271:Naltrexone / Q000627:therapeutic use*; D009292:Narcotic Antagonists / Q000627:therapeutic use*; D058850:Opiate Substitution Treatment; D009293:Opioid-Related Disorders / Q000188:drug therapy* / Q000534:rehabilitation; D010358:Patient Participation; D011330:Prisons; D055502:Secondary Prevention
chemical_list: D000701:Analgesics, Opioid; D003692:Delayed-Action Preparations; D009292:Narcotic Antagonists; D009271:Naltrexone; D008691:Methadone
keywords: Criminal justice; Extended-release naltrexone; Jail; Naltrexone; Opioid relapse prevention