Clinical trialNCT04219540CompletedPhase 4Interventional

Long-acting Buprenorphine vs. Naltrexone Opioid Treatments in CJS-involved Adults

SponsorNYU Langone HealthEnrollment675Opioid-use Disorder

View the registry record on ClinicalTrials.gov

Summary

The lay summary the sponsor registered on ClinicalTrials.gov.

This study seeks to compare the effectiveness of two medications used to treat opioid use disorder, extended-release buprenorphine (XR-B) vs. extended-release naltrexone (XR-NTX), among adults currently incarcerated in U.S. jails and prisons at 5 distinct trial sites. This open-label, non-inferiority, head-to-head study design will offer providers, correctional and public health authorities, payers and policy makers' timely and relevant data to assess the effectiveness of XR-B (and XR-NTX) as potentially useful re-entry and relapse prevention treatment options. It is hypothesized that XR-B is non-inferior to XR-NTX when comparing retention-in-study-medication treatment options.

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Investigators

The overall officials registered on this study. Names that resolve to a findmyKOL profile link to it; the rest are shown as registered.

Joshua Lee, MD
NYU Langone
Principal Investigator
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A profile link is shown only when the registered name resolves to a person record with a confident, namesake-checked match; ambiguous names stay unlinked.

Sites

6 registered facilities, with the per-site recruitment status where the registry publishes one. ClinicalTrials.gov does not publish per-site enrollment counts.

United States

Yale University School of Medicine
New Haven, Connecticut, United States
Friends Research Institute
Baltimore, Maryland, United States
Dartmouth College
Hanover, New Hampshire, United States
Rutgers University
New Brunswick, New Jersey, United States
Nyu Langone Health
New York, New York, United States
Oregon Health and Science University
Portland, Oregon, United States

Site investigator names are published by ClinicalTrials.gov only while a study recruits, so completed studies list sites without them.

Drugs studied

The drug and biological interventions registered on this study, normalized to their RxNorm ingredient where possible.

XR-BXR-NTX

Linked drugs open the directory filtered to KOLs working with them.clinicaltrials.gov ↗

Registration & key dates

Registry attributes as recorded on the ClinicalTrials.gov study record.

Start: 7 Jan 2021
Primary completion: 1 Aug 2024
Completion: 28 Feb 2025
Last update posted: 14 May 2025
Registered enrollment: 675
Registry id: NCT04219540

clinicaltrials.gov ↗

Source: ClinicalTrials.gov, via the CTTI AACT database, data as of 24 Aug 2026. Registry facts are shown as registered by the study sponsor; findmyKOL does not interpret them.