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

Abstract

Background

Individuals involved in the criminal legal system represent one of the most disproportionately affected populations in the opioid overdose crisis. Despite evidence of medications for opioid use disorder (MOUD) reducing overdose mortality, illicit opioid use, and recidivism, most correctional facilities do not offer these treatments. Sublocade and Brixadi, two distinct, branded, formulations of extended-release buprenorphine (XR-B), offer a promising approach to improving MOUD treatment adherence and reducing post-release overdose deaths.

Methods

This hybrid pilot study will utilize a partially randomized preference trial (PRPT) design to compare the preliminary effectiveness, feasibility, acceptability and other outcomes between Sublocade and Brixadi initiation. We aim to enroll 60 incarcerated individuals with opioid use disorder who are interested in XR-B and have a scheduled release within 120 days. Participants will choose their preferred injectable treatment or, if ambivalent, be randomly assigned. All participants will receive monthly XR-B injections pre-release and continue for three months post-release, with additional administrative follow-up for another three months. The primary outcome is post-release treatment retention; other outcomes will be assessed using the Proctor taxonomy. Data will be collected using clinical assessments, surveys, and administrative databases.

Discussion

This study explores differences in XR-B formulations during the high-risk time of transition out of prison. It combines a hybrid implementation science and preference trial design—two methodologies that can help address the specific challenges of research in carceral environments. By understanding implementation of XR-B in a prison setting, findings can provide valuable insights to guide other facilities in adopting this life-saving treatment.