Extended-release naltrexone to prevent relapse among opioid dependent, criminal justice system involved adults: Rationale and design of a randomized controlled effectiveness trial

Joshua D. Lee, Peter D. Friedmann, Tamara Y. Boney, Randall A. Hoskinson, Ryan McDonald, Michael Gordon, Marc Fishman, Donna T. Chen, Richard J. Bonnie, Timothy W. Kinlock, Edward V. Nunes, James W. Cornish, Charles P. O'Brien

Research output: Contribution to journalArticle

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.

Original languageEnglish (US)
Pages (from-to)110-117
Number of pages8
JournalContemporary Clinical Trials
Volume41
DOIs
StatePublished - Mar 1 2015

    Fingerprint

Keywords

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

ASJC Scopus subject areas

  • Pharmacology (medical)

Cite this

Lee, J. D., Friedmann, P. D., Boney, T. Y., Hoskinson, R. A., McDonald, R., Gordon, M., Fishman, M., Chen, D. T., Bonnie, R. J., Kinlock, T. W., Nunes, E. V., Cornish, J. W., & O'Brien, C. P. (2015). Extended-release naltrexone to prevent relapse among opioid dependent, criminal justice system involved adults: Rationale and design of a randomized controlled effectiveness trial. Contemporary Clinical Trials, 41, 110-117. https://doi.org/10.1016/j.cct.2015.01.005