Strengthening buprenorphine treatment for Individuals in carceral settings (STAND): A hybrid implementation-effectiveness trial of long-acting injectable versus sublingual buprenorphine

PROJECT ABSTRACT This proposal is a large hybrid type 1 implementation effectiveness randomized controlled trial evaluating the comparative effectiveness of long-acting injectable buprenorphine (XRB) versus sublingual buprenorphine (SLB) among incarcerated adult volunteers with opioid use disorder (OUD) who are preparing for release. Both treatments are FDA-approved for OUD, and XRB offers the potential to improve adherence and reduce barriers to consistent medication use in correctional and community settings. The study will address the urgent need for high-quality data comparing these two buprenorphine formulations in corrections-to-community transitions, where individuals face heightened risks for overdose and poor treatment engagement. Participants will be recruited from three diverse Department of Corrections sites: Yale/Connecticut DOC, Dartmouth/New Hampshire DOC, and Friends Research Institute/Delaware DOC. The study team, which includes experienced PIs and academic partners, has long-standing collaborations with these sites, established protocols for XRB and SLB administration in correctional settings, and strong linkage systems to community care. A total of 300 adult participants with moderate-to-severe OUD will be randomized 1:1 to XRB or SLB prior to release, with the primary outcome being retention on buprenorphine at 12 weeks post-release. Secondary outcomes will include substance use measures, overdose events, qualitative feedback from participants, implementation feasibility, and cost analyses. This open-label, hybrid type 1 implementation-effectiveness trial leverages an innovative design to evaluate not only the clinical effectiveness of these medications but also the feasibility and relative costs of their implementation in correctional settings. As the first large multi-site trial of XRB versus SLB in this population, the study addresses key public health priorities and aligns with the NIH HEAL initiative’s goals to reduce opioid overdose deaths and improve treatment engagement during the critical post-release period. Findings from this study have the potential to inform best practices and expand the accessibility of medication for opioid use disorder (MOUD) in underserved carceral populations.