Assessing Optimal XRB Initiation Points in Jail

Phase 4

Not yet recruiting

• Conditions: Opioid Use Disorder
• Interventions: Drug: Extended-Release Buprenorphine (XRB); Drug: Sublingual Buprenorphine (SLB)

• Registration Number: NCT06051890
• Lead Sponsor: NYU Langone Health

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-09-18
• Study First Submitted QC: 2023-09-18
• Study First Posted: 2023-09-25
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-21
• Last Update Posted: 2025-04-22
• Study Start: 2025-05-31
• Primary Completion: 2026-12-01
• Study Completion: 2027-03-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: Male
• Target Recruitment: 200

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Transition to Extended-Release Buprenorphine (XRB)	Extended-Release Buprenorphine (XRB)	Participants randomized to transition to treatment with XRB.
Sublingual Buprenorphine (SLB) Maintenance	Sublingual Buprenorphine (SLB)	Participants randomized to remain on-treatment with SLB.

Primary Outcome Measures

Name	Time	Method
Percentage of participants released from jail with at least 7 days of buprenorphine in their system	Up to Month 6	The percentage of participants leaving jail with at least 7 days of buprenorphine protection in their system. Measured using clinical and jail records.

Secondary Outcome Measures

Name	Time	Method
Percentage of participants continuing MOUD treatment in the community	Up to Month 9	Percentage of participants who continue to access medication for opioid use disorder (MOUD) once released from jail. This will be based on community clinic records indicating admission and retention.

Trial Locations

Locations (4)

Tufts University Health Sciences; 🇺🇸 Boston, Massachusetts, United States

Middlesex County House of Corrections; 🇺🇸 New Brunswick, New Jersey, United States

NYU Langone Health - 180 Madison Ave; 🇺🇸 New York, New York, United States

Baystate Health; 🇺🇸 Springfield, Massachusetts, United States