# Long-acting buprenorphine vs. naltrexone opioid treatments in CJS-involved adults

> **NIH NIH U01** · NEW YORK UNIVERSITY SCHOOL OF MEDICINE · 2024 · $2,498,125

## Abstract

PROJECT SUMMARY
This proposal is a large multi-site site randomized controlled trial evaluating the effectiveness of the newly FDA-
approved extended-release buprenorphine formulation (XR-B, SUBLOCADETM) vs. extended-release naltrexone
(XR-NTX) among currently incarcerated adult volunteers with moderate-to-severe opioid use disorders (OUD)
with an upcoming release date. XR-B may be an effective CJS intervention alongside other OUD medications
and may ultimately allow for much wider uptake of opioid agonist medication treatments in CJS populations.
High quality effectiveness data for XR-B in CJS is urgently needed.
The Multiple PI and Academic CJS partners participating in this consortium will recruit participants from 5 distinct
CJS trial sites including: (1) NYU School of Medicine/NYC DOC jail system, (2) Yale/Connecticut DOC, (3)
Dartmouth/New Hampshire DOC, (4) Oregon Health & Science University-UCLA/Multnomah County, and (5)
Friends Research Institute/Delaware DOC. The PIs and DOC Co-Investigators or collaborators are deeply
experienced in working with CJS opioid patient populations and leading high-quality and collaborative NIH clinical
trials focused on opioid medication treatments. Trial sites vary considerably, from unified statewide prison/jail
systems (CT, DE, NH) to large urban municipal jails (NYC, Portland OR), and with diverse experience with opioid
medications as usual care, including methadone (NYC, CT, Portland), SL-B (NYC, CT, DE, Portland), and small
XR-NTX pilots (all sites). All of these locations and CJS authorities face unprecedented pressure to contribute
CJS-opioid solutions and help reverse the historically high rates of opioid overdose deaths, particularly following
release from corrections.
A 5-site, open-label, non-inferiority, head-to-head design will randomly assign 666 adult volunteers soon-to-be-
released with moderate-to-severe opioid use disorders (OUD) 1:1 to XR-B or XR-NTX in corrections followed by
24-weeks of post-release community treatment, and final long-term follow-up at 12-months. An additional 334
OUD individuals otherwise eligible but not interested in the RCT will be recruited into a quasi-experimental
treatment-as-usual 3rd study arm (TAU), for a total recruited sample of N=1,000. Participants will be referred to
appropriate community treatment options at Week 24. Final follow-up will occur at Week 52. The primary
outcome is retention-in-study medication-treatment during Weeks 1-24 (6 scheduled monthly injections), using
a non-inferiority comparison. Secondary outcomes will compare opioid treatment outcomes (e.g. opioid-positive
urine samples and self-reported opioid use, other drug/alcohol use, safety events, and HCV, HIV
seroconversion). A 3rd non-randomized, quasi-experimental arm of OUD individual (n=334) otherwise eligible but
not enrolling in the RCT will allow comparisons with treatment-as-usual (TAU) across the 5 sites.

## Key facts

- **NIH application ID:** 11044583
- **Project number:** 4U01DA047982-02
- **Recipient organization:** NEW YORK UNIVERSITY SCHOOL OF MEDICINE
- **Principal Investigator:** DAVID J FARABEE
- **Activity code:** U01 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2024
- **Award amount:** $2,498,125
- **Award type:** 4N
- **Project period:** 2019-08-01 → 2026-04-30

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/11044583

## Citation

> US National Institutes of Health, RePORTER application 11044583, Long-acting buprenorphine vs. naltrexone opioid treatments in CJS-involved adults (4U01DA047982-02). Retrieved via AI Analytics 2026-05-22 from https://api.ai-analytics.org/grant/nih/11044583. Licensed CC0.

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