title: Extended-release naltrexone for pre-release prisoners: A randomized trial of medical mobile treatment.
abstract: Extended-release naltrexone (XR-NTX), is an effective treatment for opioid use disorder but is rarely initiated in US prisons or with criminal justice populations. Mobile treatment for chronic diseases has been implemented in a variety of settings. Mobile treatment may provide an opportunity to expand outreach to parolees to surmount barriers to traditional clinic treatment.
  
  
  
  Male and female prisoners (240) with pre-incarceration histories of opioid use disorder who are within one month of release from prison will be enrolled in this randomized clinical trial. Participants are randomized to one of two study arms: 1) [XR-NTX-OTx] One injection of long-acting naltrexone in prison, followed by 6 monthly injections post-release at a community opioid treatment program; or 2) [XR-NTX+ MMTx] One injection of long-acting naltrexone in prison followed by 6 monthly injections post-release at the patient's place of residence utilizing mobile medical treatment. The primary outcomes are: treatment adherence; opioid use; criminal activity; re-arrest; reincarceration; and HIV risk-behaviors.
  
  
  
  We describe the background and rationale for the study, its aims, hypotheses, and study design.
  
  
  
  The use of long-acting injectable naltrexone may be a promising form of treatment for pre-release prisoners. Finally, as many individuals in the criminal justice system drop out of treatment, this study will assess whether treatment at their place of residence will improve adherence and positively affect treatment outcomes. ClinicalTrials.gov: NCT02867124.
authors.affiliation: Friends Research Institute, Baltimore, MD, USA. Electronic address: mgordon@friendsresearch.org.
authors.forename: Michael S
authors.initials: MS
authors.lastname: Gordon
authors.affiliation: Friends Research Institute, Baltimore, MD, USA.
authors.forename: Frank J
authors.initials: FJ
authors.lastname: Vocci
authors.affiliation: Glenwood Life Counseling Center, Baltimore, MD, USA.
authors.forename: Terrence T
authors.initials: TT
authors.lastname: Fitzgerald
authors.affiliation: Department of Psychology, University of Maryland, College Park, MD, USA.
authors.forename: Kevin E
authors.initials: KE
authors.lastname: O'Grady
authors.affiliation: Department of Psychiatry, University of Pennsylvania, Philadelphia, PA, USA.
authors.forename: Charles P
authors.initials: CP
authors.lastname: O'Brien
mesh_terms: D003415:Crime / Q000706:statistics & numerical data; D003692:Delayed-Action Preparations; D003695:Delivery of Health Care / Q000379:methods*; D005260:Female; D015658:HIV Infections; D006801:Humans; D007273:Injections, Intramuscular; D008297:Male; D055118:Medication Adherence; D008952:Mobile Health Units; D009271:Naltrexone / Q000008:administration & dosage*; D009292:Narcotic Antagonists / Q000008:administration & dosage*; D009293:Opioid-Related Disorders / Q000188:drug therapy*; D011329:Prisoners; D011330:Prisons; D012008:Recurrence; D012309:Risk-Taking; D016320:Substance Abuse Treatment Centers; D014481:United States
chemical_list: D003692:Delayed-Action Preparations; D009292:Narcotic Antagonists; D009271:Naltrexone
keywords: Criminal justice; Long-acting naltrexone; Medical mobile treatment; Prisoners