Starting monthly extended‑release buprenorphine (XRB) when someone is booked into jail
Assessing Optimal Extended-Release Buprenorphine (XRB) Initiation Points in Jail
This project will try switching adults booked into jail who are already taking daily sublingual buprenorphine to a monthly injected buprenorphine at admission versus continuing daily sublingual, to see which helps people leave jail with ongoing buprenorphine and stay in treatment.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 200 (estimated) |
| Sex | Male |
| Sponsor | NYU Langone Health Academic / other |
| Locations | 4 sites (Boston, Massachusetts and 3 other locations) |
| Trial ID | NCT06051890 on ClinicalTrials.gov |
What this trial studies
This is a 3‑year, randomized controlled trial enrolling 200 consenting, unsentenced adults entering participating jails who have been taking sublingual buprenorphine (SLB) for at least three days. Participants are randomized 1:1 at admission to be switched to extended‑release buprenorphine (XRB) while incarcerated or to continue SLB; all participants receive naloxone. Primary comparisons include the percent released from jail with at least seven days of buprenorphine in their system, the percent continuing medication for opioid use disorder (MOUD) in the community, and infractions related to buprenorphine diversion. The trial is led by NYU Langone Health with NIDA collaboration and is conducted at partnering sites including Middlesex County House of Corrections and affiliated health systems.
Who should consider this trial
Good fit: Unsentenced, English‑speaking adults entering participating jails who have been prescribed and taking sublingual buprenorphine for at least three days and who can provide informed consent are the intended participants.
Not a fit: People who are already sentenced, have allergies or medical contraindications to buprenorphine, require ongoing opioid pain management, or have very short expected stays (under four days) are unlikely to benefit from this approach.
Why it matters
Potential benefit: If successful, initiating XRB at jail admission could help more people leave jail with continuous buprenorphine protection, increase treatment continuity after release, and reduce diversion-related problems.
How similar studies have performed: Extended‑release buprenorphine has shown improved retention over daily sublingual formulations in other trials, but initiating XRB specifically at jail admission has only limited prior pilot data.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Incarcerated men able to provide written informed consent in English.\* * Unsentenced. * Entering the facility with a prescription for SLB and receiving SLB for at least the previous 3 days. * Minimum anticipated jail stay is 4 days. * Willing to accept being randomized to the experimental condition (i.e., transitioning to XRB while incarcerated). Exclusion Criteria: * Sentenced. * Allergy, hypersensitivity or medical contraindication to either medication. * Chronic pain requiring opioid pain management or other contraindicated medications.
Where this trial is running
Boston, Massachusetts and 3 other locations
- Tufts University Health Sciences — Boston, Massachusetts, United States (Recruiting)
- Baystate Health — Springfield, Massachusetts, United States (Recruiting)
- Middlesex County House of Corrections — New Brunswick, New Jersey, United States (Recruiting)
- NYU Langone Health - 180 Madison Ave — New York, New York, United States (Recruiting)
Study contacts
- Principal investigator: David Farabee, PhD — NYU Langone Health
- Study coordinator: David Farabee
- Email: David.farabee@nyulagone.org
- Phone: 310-963-0009
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.