RecruitingPhase 4NCT06051890

Assessing Optimal XRB Initiation Points in Jail

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

Sponsor

NYU Langone Health

Enrollment

200 participants

Start Date

Jun 2, 2025

Study Type

INTERVENTIONAL

Conditions

Opioid-use Disorder

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.

Eligibility

Sex: MALE

Inclusion Criteria5

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 Criteria3

Sentenced.
Allergy, hypersensitivity or medical contraindication to either medication.
Chronic pain requiring opioid pain management or other contraindicated medications.

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Interventions

DRUGExtended-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.

DRUGSublingual Buprenorphine (SLB)

Maintenance of existing SLB prescription (treatment as usual).