title: Extended-release naltrexone to prevent relapse among opioid dependent, criminal justice system involved adults: rationale and design of a randomized controlled effectiveness trial.
abstract: BACKGROUND
  Extended-release naltrexone (XR-NTX, Vivitrol; Alkermes Inc.) is an injectable monthly sustained-release mu opioid receptor antagonist. XR-NTX is a potentially effective intervention for opioid use disorders and as relapse prevention among criminal justice system (CJS) populations.
  
  
  METHODS
  This 5-site open-label randomized controlled effectiveness trial examines whether XR-NTX reduces opioid relapse compared with treatment as usual (TAU) among community dwelling, non-incarcerated volunteers with current or recent CJS involvement. The XR-NTX arm receives 6 monthly XR-NTX injections at Medical Management visits; the TAU group receives referrals to available community treatment options. Assessments occur every 2 weeks during a 24-week treatment phase and at 12- and 18-month follow-ups. The primary outcome is a relapse event, defined as either self-report or urine toxicology evidence of ≥10 days of opioid use in a 28-day (4 week) period, with a positive or missing urine test counted as 5 days of opioid use.
  
  
  RESULTS
  We describe the rationale, specific aims, and design of the study. Alternative design considerations and extensive secondary aims and outcomes are discussed.
  
  
  CONCLUSIONS
  XR-NTX is a potentially important treatment and relapse prevention option among persons with opioid dependence and CJS involvement. ClinicalTrials.gov: NCT00781898.
authors.affiliation: Department of Population Health and Division of General Internal Medicine, New York University, United States. Electronic address: joshua.lee@med.nyu.edu.
authors.forename: Joshua D
authors.initials: JD
authors.lastname: Lee
authors.affiliation: Division of General Internal Medicine, Alpert Medical School of Brown University/Rhode Island Hospital and Providence Veterans Affairs Medical Center, United States.
authors.forename: Peter D
authors.initials: PD
authors.lastname: Friedmann
authors.affiliation: University of Pennsylvania, United States.
authors.forename: Tamara Y
authors.initials: TY
authors.lastname: Boney
authors.affiliation: Division of General Internal Medicine, Alpert Medical School of Brown University/Rhode Island Hospital and Providence Veterans Affairs Medical Center, United States.
authors.forename: Randall A
authors.initials: RA
authors.lastname: Hoskinson
authors.affiliation: Department of Population Health and Division of General Internal Medicine, New York University, United States.
authors.forename: Ryan
authors.initials: R
authors.lastname: McDonald
authors.affiliation: Friends Research Institute, United States.
authors.forename: Michael
authors.initials: M
authors.lastname: Gordon
authors.affiliation: Friends Research Institute, United States; Maryland Treatment Centers, United States.
authors.forename: Marc
authors.initials: M
authors.lastname: Fishman
authors.affiliation: Center for Biomedical Ethics and Humanities, University of Virginia School of Medicine, United States.
authors.forename: Donna T
authors.initials: DT
authors.lastname: Chen
authors.affiliation: University of Virginia School of Law, United States.
authors.forename: Richard J
authors.initials: RJ
authors.lastname: Bonnie
authors.affiliation: Friends Research Institute, United States; University of Baltimore, School of Criminal Justice, United States.
authors.forename: Timothy W
authors.initials: TW
authors.lastname: Kinlock
authors.affiliation: New York State Psychiatric Institute, Columbia University, College of Physicians and Surgeons, United States.
authors.forename: Edward V
authors.initials: EV
authors.lastname: Nunes
authors.affiliation: University of Pennsylvania, United States.
authors.forename: James W
authors.initials: JW
authors.lastname: Cornish
authors.affiliation: University of Pennsylvania, United States.
authors.forename: Charles P
authors.initials: CP
authors.lastname: O'Brien
mesh_terms: D000328:Adult; D003416:Criminal Law; D057237:Criminals; D003692:Delayed-Action Preparations; D005260:Female; D006801:Humans; D007273:Injections, Intramuscular; D008297:Male; D009271:Naltrexone / Q000627:therapeutic use*; D009292:Narcotic Antagonists / Q000627:therapeutic use*; D009293:Opioid-Related Disorders / Q000188:drug therapy*; D055502:Secondary Prevention
chemical_list: D003692:Delayed-Action Preparations; D009292:Narcotic Antagonists; D009271:Naltrexone
keywords: Criminal justice; Extended-release naltrexone; Naltrexone; Opioid relapse prevention