Buprenorphine Formulations for Opioid Use Disorder in Jail

Recruiting in Palo Alto (17 mi)

+3 other locations

Overseen byDavid Farabee, PhD

Age: Any Age

Sex: Male

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 4

Waitlist Available

Sponsor: NYU Langone Health

No Placebo Group

Prior Safety Data

Trial Summary

What is the purpose of this trial?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

This trial is for unsentenced men entering Middlesex County House of Corrections with an existing prescription for Sublingual Buprenorphine (SLB), having taken it for at least 3 days, and willing to be randomly assigned to a new treatment. They must understand English, agree to the study's terms, and expect to stay in jail for at least 4 days. Those with chronic pain needing opioids or allergies to the medications cannot join.

Inclusion Criteria

You are expected to stay in jail for a minimum of four days.

You are willing to be randomly assigned the opportunity of transitioning to XRB whilst in custody.

Unsentenced

+2 more

Exclusion Criteria

Sentenced

I need opioids or similar medications to manage my chronic pain.

I am allergic or have a bad reaction to certain medications.

Participant Groups

The study compares two treatments for opioid addiction in jailed individuals: one group will switch from SLB to Extended-Release Buprenorphine (XRB) upon admission, while the other remains on SLB. The goal is to see which method is better at ensuring participants have medication when released, continue treatment outside jail, and reduce drug-related infractions.

2Treatment groups

Experimental Treatment

Active Control

Group I: Transition to Extended-Release Buprenorphine (XRB)Experimental Treatment1 Intervention

Participants randomized to transition to treatment with XRB.

Group II: Sublingual Buprenorphine (SLB) MaintenanceActive Control1 Intervention

Participants randomized to remain on-treatment with SLB.