NCT06051890

Assessing Optimal XRB Initiation Points in Jail

Assessing Optimal Extended-Release Buprenorphine (XRB) Initiation Points in Jail

• Status: Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 200 (estimated)
• Sponsor: NYU Langone Health · Academic / Other
• Sex: Male
• Age: —
• Healthy volunteers: Not accepted

Summary

This application describes a 3-year, randomized controlled trial. Eligible, consenting adults (N=200) with existing sublingual buprenorphine (SLB) prescriptions who enter Middlesex County House of Corrections (MCHOC) as pre-trial detainees will be randomized at admission on a 1:1 basis to be inducted onto extended-release buprenorphine (XRB) at the time of admission (experimental condition) or remain in SLB (E-TAU; all participants will also receive naloxone). The two approaches will be compared with regard to (1) the percentage of participants released from jail with at least 7 days of buprenorphine in their system, (2) percentage of participants continuing MOUD treatment in the community, and (3) infractions related to buprenorphine diversion.

Conditions

• Opioid Use Disorder

Interventions

Type	Name	Description
DRUG	Extended-Release Buprenorphine (XRB)	XRB (Sublocade) will be delivered as a pre-filled 2cc subcutaneous monthly injection, using a 300mg starting dose in most cases (100mg starting doses are available per the study team's clinical judgement). XRB consists of a depot injectable formulation in polymeric solution to the abdomen and releases buprenorphine over 28-days (4-weeks) by diffusion as the polymer biodegrades. Prior to an initial injection, the participant must be stable for several days or longer on sublingual buprenorphine (SLB) at doses of 8mg/day or higher. Participants will receive at least one XRB monthly injection prior to release, which investigators anticipate to usually be the 300mg dose. Some participants will be recruited earlier during the incarceration (or experience delayed release dates and then longer than anticipated incarcerations); XRB will be continued monthly from the time of induction to the day of release.
DRUG	Sublingual Buprenorphine (SLB)	Maintenance of existing SLB prescription (treatment as usual).

Timeline

• Start date: 2025-06-02
• Primary completion: 2026-12-01
• Completion: 2027-03-01
• First posted: 2023-09-25
• Last updated: 2025-09-10

Locations

4 sites across 1 country: United States

Regulatory

• FDA-regulated drug study