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

This proposed randomized control trial will test the pharmacotherapy adherence (number of monthly injections received) of extended-release buprenorphine (XR-B) versus extended-release naltrexone (XR-NTX) among adults with opioid use disorder (OUD) who are nearing release from county jails in Maryland. The results of this trial will have substantial public health implications as most individuals with OUD…

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A Comparative Effectiveness Trial of Extended-release Naltrexone and Extended-release Buprenorphine (Brixadi) with Individuals Leaving Jail (034)

This study is conducting a comparative effectiveness trial of extended-release naltrexone (XR-NTX) versus a new extended-release formulation of buprenorphine (Brixadi, XR-B) to treat opioid use disorder (OUD) among justice-involved individuals in ten Maryland county jails.

Participants will be randomly assigned to receive either XR-NTX or XR-B prior to release from jail, followed by six monthly injections while in the community. The goal of the study is to evaluate the effectiveness of the two medications, measure medication adherence, and gather data to inform broader scale-up of medications for opioid use disorder (MOUD) in jails and in the community.

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