A clinical protocol of a comparative effectiveness trial of extended-release naltrexone versus extended-release buprenorphine with individuals leaving jail. Academic Article uri icon

Overview

abstract

  • This study is a randomized, open label, controlled trial of extended-release buprenorphine (XR-B; BRIXADIâ„¢ formulation) versus extended-release naltrexone (XR-NTX) in Maryland jails. A 7-site, open-label, equivalence design will randomly assign 240 adults with a history of opioid use disorder (OUD), stratified by gender and jail, who are nearing release to one of two treatment arms: 1) XR-B in jail or 2) XR-NTX in jail, both followed by 6 monthly injections postrelease at a community treatment program. The primary aim is to determine the rate of pharmacotherapy adherence (number of monthly injections received) of XR-B compared to XR-NTX. The proposed study is innovative because it will be the first randomized clinical trial in the U.S. assessing the effectiveness of receiving XR-B vs. XR-NTX in county jails. The public health impact of the study will be highly significant and far-reaching because most individuals with OUD do not receive treatment while incarcerated, thereby substantially raising their likelihood of relapse to drug use, overdose death, and re-incarceration. Understanding how to expand acceptance of medications for OUD in jails, particularly extended-release medications, and supporting treatment engagement and medication adherence in transition to the community, has far-reaching implications for improving treatment access and success in this population.

publication date

  • December 11, 2020

Research

keywords

  • Buprenorphine
  • Opioid-Related Disorders

Identity

Scopus Document Identifier

  • 85097885505

Digital Object Identifier (DOI)

  • 10.1016/j.jsat.2020.108241

PubMed ID

  • 33339633

Additional Document Info

volume

  • 128