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.

Keywords: Criminal justice; Extended-release naltrexone; Naltrexone; Opioid relapse prevention.

Conflict of interest statement

Conflicts of Interest: Dr. Lee has received investigator initiated study funding and study drug in-kind from Alkermes and Reckitt Benckiser for additional studies. Drs. Gordon and Kinlock received investigator initiated study funding and study drug in-kind from Alkermes for an additional study. Dr. Nunes has received: medication in-kind for research studies from Alkermes/Cephalon, Inc., Reckitt-Benckiser, and Duramed Pharmaceuticals; web-based behavioral intervention for research study from HealthSim, LLC; devices under investigation and reimbursement for travel for investigators’ meeting from Brainsway. He was paid an honorarium and received reimbursement for travel for attendance at a Lilly Advisory Board Meeting in January 2012 and received educational materials from Otsuka America Pharmaceutical, Inc. in 2013. He plans to serve on Advisory Board for Alkermes in October 2014. Dr. O’Brien has served as a consultant to Alkermes.

Copyright © 2015 Elsevier Inc. All rights reserved.

Figures

Figure 1

Study Flow, Inclusion/Exclusion Criteria, and Outcomes