biostudies-literatureGordon MSBraeburn Pharmaceuticals, Inc.NIDA NIH HHSNational Institutes of HealthNational Institute on Drug Abuse108241https://www.ebi.ac.uk/biostudies/studies/S-EPMC8898543biostudies-literatureUnknown128This 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-NJournal of substance abuse treatmentA clinical protocol of a comparative effectiveness trial of extended-release naltrexone versus extended-release buprenorphine with individuals leaving jail.PMC8898543UG1 DA0500771UG1DA050077Couvillion KDanner MLBlue TRMaher KFishman MJMurphy SMMitchell SGJarvis DKGordon MSWenzel KRyan DVocci FJfalseA clinical protocol of a comparative effectiveness trial of extended-release naltrexone versus extended-release buprenorphine with individuals leaving jail.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-N2021-01-01T00:00:00Z2021 Sep2025-04-04T23:02:34.182Z2025-04-04T23:02:34.182ZS-EPMC88985433333963310.1016/j.jsat.2020.108241