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NCT06051890PHASE4Recruiting

Assessing Optimal XRB Initiation Points in Jail

NYU Langone Health

Start Date

6/2/2025

Completion Date

3/1/2027

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 Criteria

Age Range: No minimum to No maximum

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.

Interventions

DRUG

Extended-Release Buprenorphine (XRB)

DRUG

Sublingual Buprenorphine (SLB)

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Conditions

Opioid Use Disorder

Locations

Tufts University Health Sciences

Boston, Massachusetts 02111

United States

Baystate Health

Springfield, Massachusetts 01199

United States

Middlesex County House of Corrections

New Brunswick, New Jersey 08902

United States

NYU Langone Health - 180 Madison Ave

New York, New York 10016

United States