Citation

Lee JD, Friedmann PD, Boney TY, Hoskinson Jr. RA, McDonald R, Gordon M, Fishman M, Chen DT, Bonnie RJ, Kinlock TW, Nunes EV, Cornish JW, O'Brien CP. Contemp. Clin. Trials 2015; 41: 110-117.

Copyright

(Copyright © 2015, Elsevier Publishing)

DOI

10.1016/j.cct.2015.01.005

PMID

unavailable

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

Language: en