Joshua D Lee1, Peter D Friedmann2, Tamara Y Boney3, Randall A Hoskinson2, Ryan McDonald4, Michael Gordon5, Marc Fishman6, Donna T Chen7, Richard J Bonnie8, Timothy W Kinlock9, Edward V Nunes10, James W Cornish3, Charles P O'Brien3. 1. Department of Population Health and Division of General Internal Medicine, New York University, United States. Electronic address: joshua.lee@med.nyu.edu. 2. Division of General Internal Medicine, Alpert Medical School of Brown University/Rhode Island Hospital and Providence Veterans Affairs Medical Center, United States. 3. University of Pennsylvania, United States. 4. Department of Population Health and Division of General Internal Medicine, New York University, United States. 5. Friends Research Institute, United States. 6. Friends Research Institute, United States; Maryland Treatment Centers, United States. 7. Center for Biomedical Ethics and Humanities, University of Virginia School of Medicine, United States. 8. University of Virginia School of Law, United States. 9. Friends Research Institute, United States; University of Baltimore, School of Criminal Justice, United States. 10. New York State Psychiatric Institute, Columbia University, College of Physicians and Surgeons, United States.
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.
RCT Entities:
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.
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