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J Subst Abuse Treat · Sep 2021
A clinical protocol of a comparative effectiveness trial of extended-release naltrexone versus extended-release buprenorphine with individuals leaving jail.
- Michael S Gordon, Shannon Gwin Mitchell, Thomas R Blue, Frank J Vocci, Marc J Fishman, Sean M Murphy, Kathy Couvillion, Kelly Maher, Danielle Ryan, Kevin Wenzel, Martha L Danner, and Daniel K Jarvis.
- Friends Research Institute, Inc., 1040 Park Avenue, Suite 103, Baltimore, MD 21201, United States of America. Electronic address: mgordon@friendsresearch.org.
- J Subst Abuse Treat. 2021 Sep 1; 128: 108241.
AbstractThis 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.Copyright © 2020 Elsevier Inc. All rights reserved.
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