A clinical protocol of a comparative effectiveness trial of extended-release naltrexone versus extended-release buprenorphine with individuals leaving jail

J Subst Abuse Treat. 2021 Sep;128:108241. doi: 10.1016/j.jsat.2020.108241. Epub 2020 Dec 11.


This study is a randomized, open label, controlled trial of extended-release buprenorphine (XR-B; BRIXADI™ 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.

Keywords: Extended-release buprenorphine; Extended-release naltrexone; Jail; Justice-involved; Medications for opioid use disorders.

Publication types

  • Clinical Trial Protocol
  • Research Support, N.I.H., Extramural
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adult
  • Buprenorphine* / therapeutic use
  • Clinical Protocols
  • Delayed-Action Preparations / therapeutic use
  • Humans
  • Injections, Intramuscular
  • Jails
  • Naltrexone / therapeutic use
  • Narcotic Antagonists / therapeutic use
  • Opioid-Related Disorders* / drug therapy
  • Randomized Controlled Trials as Topic


  • Delayed-Action Preparations
  • Narcotic Antagonists
  • Buprenorphine
  • Naltrexone