Injectable buprenorphine during transition out of prison: A pilot partially randomized preference trial protocol.

Area of Science:

• Criminal justice health
• Addiction medicine
• Implementation science

Background:

• Individuals in the criminal legal system face disproportionately high rates of opioid overdose.
• Medications for opioid use disorder (MOUD) reduce overdose deaths, illicit use, and recidivism, yet are underutilized in correctional facilities.
• Extended-release buprenorphine (XR-B) formulations, Sublocade and Brixadi, present a promising MOUD strategy for this population.

Purpose of the Study:

• To compare the preliminary effectiveness, feasibility, and acceptability of Sublocade versus Brixadi initiation in incarcerated individuals with opioid use disorder.
• To evaluate XR-B treatment retention during the critical transition period from incarceration to the community.
• To inform the adoption of XR-B treatments in correctional settings.

Main Methods:

• A hybrid pilot study employing a partially randomized preference trial (PRPT) design.
• Enrollment of 60 incarcerated individuals with opioid use disorder interested in XR-B and scheduled for release within 120 days.
• Monthly XR-B injections pre-release, continuing for three months post-release, with subsequent administrative follow-up.

Main Results:

• The study will assess post-release treatment retention as the primary outcome.
• Additional outcomes will be evaluated using the Proctor taxonomy, clinical assessments, surveys, and administrative data.
• Preliminary data will elucidate differences in XR-B formulation effectiveness and patient experience.

Conclusions:

• This research addresses the challenges of conducting studies within carceral environments using a hybrid implementation science and preference trial design.
• Findings will offer insights into the implementation of XR-B in prisons, guiding wider adoption.
• The study aims to enhance MOUD treatment adherence and reduce post-release overdose mortality.