NCT06880718 · Lifespan
Injectable Buprenorphine in Prison: A Preference Trial
What this study is about
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.
View original scientific description
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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- 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
- be English speaking
Exclusion criteria
- 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.
Where
- Cranston, Rhode Island
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced May 15, 2026 · Source of record for eligibility and locations