About this trial
The goal of this pilot trial is to compare two branded extended-release buprenorphine (XR-B) formulations (Sublocade vs. Brixadi) to explore how they improve treatment retention after release from prison among incarcerated individuals with opioid use disorder (OUD) who are transitioning back into the community.
The main question it aims to answer are:
How do Sublocade and Brixadi compare in terms of feasibility, acceptability, and effectiveness? Does giving people a choice of medication affect how well they stay in treatment?
Using a partially randomized preference trial approach, there will be a comparison between participants who choose their XR-B formulation to those who are randomly assigned to see if patient preference influences treatment outcomes. The trial is a hybrid implementation-effectiveness trial.
Participants will:
* Choose which medication they prefer or be randomly assigned if they don't have a preference. * Receive monthly injections of either Sublocade or Brixadi before and after release from prison. * Complete surveys and clinical assessments on treatment experience and acceptability. * Be monitored for treatment retention, opioid use, and adverse events for six months post-release.
Researchers will compare the two treatments to see which one works better for people leaving prison and if allowing people to choose their treatment improves results.
Eligibility criteria
Qualifiers
be at least 18 years of age and incarcerated in the RIDOC facility,
be currently diagnosed with OUD and enrolled in the RIDOC MOUD program,
have an expected release date within 120 days of study enrollment,
have an interest in XR-B and
Disqualifiers
individuals who are pregnant or planning conception,
diagnosed with a severe or acute medical or psychiatric disability preventing safe study participation or making follow-up unlikely,
have a release date within 21 days of initiation, or
have previously had an allergy to buprenorphine. Post-enrollment exclusion will include individuals if there is a change in release date beyond the 120 days and therefore no longer meet original inclusion criteria. These individuals would return to usual MOUD care.
Trial design
Treatments tested in this trial
- Brixadi (Injectable Buprenorphine)
- Sublocade
Treatment groups
Sponsors and collaborators
Lifespan
Lead sponsor
Rhode Island Hospital
Sponsor institution
National Institute on Drug Abuse (NIDA)
Collaborator