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. 2021 Sep:128:108241.
doi: 10.1016/j.jsat.2020.108241. Epub 2020 Dec 11.

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

Michael S Gordon  1 , Shannon Gwin Mitchell  2 , Thomas R Blue  3 , Frank J Vocci  4 , Marc J Fishman  5 , Sean M Murphy  6 , Kathy Couvillion  7 , Kelly Maher  8 , Danielle Ryan  9 , Kevin Wenzel  10 , Martha L Danner  11 , Daniel K Jarvis  12
Affiliations

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

Michael S Gordon et al. J Subst Abuse Treat. 2021 Sep.

Abstract

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.

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Figures

Fig. 1.
Fig. 1.
Study schematic.
Fig. 2.
Fig. 2.
Schedule of activities.
See this image and copyright information in PMC

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