Assessing Optimal XRB Initiation Points in Jail

NYU Langone Health

Status and phase: Enrolling; Phase 4

Conditions: Opioid Use Disorder

Treatments: Drug: Extended-Release Buprenorphine (XRB); Drug: Sublingual Buprenorphine (SLB)

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT06051890

23-00926

Details and patient eligibility

About

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.

Enrollment: 200 estimated patients

Sex: Male

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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200 participants in 2 patient groups

Transition to Extended-Release Buprenorphine (XRB)

Experimental group

Description:

Participants randomized to transition to treatment with XRB.

Treatment:

Drug: Extended-Release Buprenorphine (XRB)

Sublingual Buprenorphine (SLB) Maintenance

Active Comparator group

Description:

Participants randomized to remain on-treatment with SLB.

Treatment:

Drug: Sublingual Buprenorphine (SLB)