title: Design and methods of a double blind randomized placebo-controlled trial of extended-release naltrexone for HIV-infected, opioid dependent prisoners and jail detainees who are transitioning to the community.
abstract: BACKGROUND
  People with opioid dependence and HIV are concentrated within criminal justice settings (CJS). Upon release, however, drug relapse is common and contributes to poor HIV treatment outcomes, increased HIV transmission risk, reincarceration and mortality. Extended-release naltrexone (XR-NTX) is an evidence-based treatment for opioid dependence, yet is not routinely available for CJS populations.
  
  
  METHODS
  A randomized, double-blind, placebo-controlled trial of XR-NTX for HIV-infected inmates transitioning from correctional to community settings is underway to assess its impact on HIV and opioid-relapse outcomes.
  
  
  RESULTS
  We describe the methods and early acceptability of this trial. In addition we provide protocol details to safely administer XR-NTX near community release and describe logistical implementation issues identified. Study acceptability was modest, with 132 (66%) persons who consented to participate from 199 total referrals. Overall, 79% of the participants had previously received opioid agonist treatment before this incarceration. Thus far, 65 (49%) of those agreeing to participate in the trial have initiated XR-NTX or placebo. Of the 134 referred patients who ultimately did not receive a first injection, the main reasons included a preference for an alternative opioid agonist treatment (37%), being ineligible (32%), not yet released (10%), and lost upon release before receiving their injection (14%).
  
  
  CONCLUSIONS
  Study findings should provide high internal validity about HIV and opioid treatment outcomes for HIV-infected prisoners transitioning to the community. The large number of patients who ultimately did not receive the study medication may raise external validity concerns due to XR-NTX acceptability and interest in opioid agonist treatments.
  
  
  BACKGROUND
  NCT01246401.
authors.affiliation: Yale University School of Medicine, Department of Internal Medicine, Section of Infectious Diseases, AIDS Program, 135 College St., Suite 323, New Haven, CT 06510, United States.
authors.forename: Angela
authors.initials: A
authors.lastname: Di Paola
authors.affiliation: Department of Medicine, Baystate Medical Center, Springfield, MA, United States.
authors.forename: Thomas
authors.initials: T
authors.lastname: Lincoln
authors.affiliation: Department of Medicine, Baystate Medical Center, Springfield, MA, United States.
authors.forename: Daniel J
authors.initials: DJ
authors.lastname: Skiest
authors.affiliation: Department of Medicine, Baystate Medical Center, Springfield, MA, United States.
authors.forename: Maureen
authors.initials: M
authors.lastname: Desabrais
authors.affiliation: Yale University School of Medicine, Department of Internal Medicine, Section of Infectious Diseases, AIDS Program, 135 College St., Suite 323, New Haven, CT 06510, United States; Yale University School of Public Health, Division of Epidemiology of Microbial Diseases, 135 College St., Suite 323, New Haven, CT 06510, United States.
authors.forename: Frederick L
authors.initials: FL
authors.lastname: Altice
authors.affiliation: Yale University School of Medicine, Department of Internal Medicine, Section of Infectious Diseases, AIDS Program, 135 College St., Suite 323, New Haven, CT 06510, United States. Electronic address: sandra.springer@yale.edu.
authors.forename: Sandra A
authors.initials: SA
authors.lastname: Springer
mesh_terms: D003142:Communication; D003692:Delayed-Action Preparations; D004311:Double-Blind Method; D005260:Female; D015658:HIV Infections / Q000453:epidemiology*; D006801:Humans; D007273:Injections, Intramuscular; D008297:Male; D009271:Naltrexone / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D009292:Narcotic Antagonists / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D009293:Opioid-Related Disorders / Q000188:drug therapy* / Q000453:epidemiology*; D010349:Patient Compliance; D011329:Prisoners; D012107:Research Design; D012309:Risk-Taking; D013997:Time Factors
chemical_list: D003692:Delayed-Action Preparations; D009292:Narcotic Antagonists; D009271:Naltrexone
keywords: Extended-release naltrexone; HIV; Opioid dependence; Prisoners; Randomized controlled trial; Vivitrol