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

Completed · Phase 4

Conditions studied: Opioid-use Disorder

In brief

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.

Key facts

Study ID: NCT04219540
Run by: NYU Langone Health
People needed: 675
Starts: 2021-01-07
Expected to finish: 2025-02-28
Last updated by the study team: 2025-05-14

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

XR-B vs. XR-NTX Inclusions:
(1) Adult volunteer aged 18 years or older able to provide written informed consent in English (or Spanish at some sites)
(2) Current CJS incarceration (residing in a controlled environment) with pending release date (within 6 months of randomization) OR community CJS-involvement defined as: a) Current CJS incarceration (residing in a controlled environment) with pending release date (within 6 months of anticipated randomization), or; b) Community-dwelling volunteers with current CJS-involvement. [Current CJS-involvement is defined as either 1) release from any CJS incarceration or detention, or 2) under community supervision (includes parole, probation, drug or other treatment court, or other alternative to incarceration supervision) within 6 months prior to study enrollment (the date of a signed ICF)].
(3) Current or history of moderate-to-severe opioid use disorder in the past year prior to incarceration (OUD, DSM-5)
(4) Not planning to move out of state or to new location within 6-months post-release (reasonable chance they can complete 6 months of follow-up visits).
(5) Willing to accept either XR-B or XR-NTX assignment.
Non-randomized TAU Inclusions:
Recruited prior to launch of RCT or not interested in or appropriate for randomization to XR-B or XR-NTX assignment (i.e, already on methadone pre-release), but are otherwise eligible based on inclusion (#1-4, above) and exclusion (#6-10, below).

You may not qualify if…

XR-B vs. XR-NTX Exclusions:
(6) Medical or psychiatric disorders making participation unsafe or regular follow-up unlikely, (such as suicidal ideation or pre-existing moderate to severe hepatic impairment)
(7) Pregnancy, planning conception, or breast-feeding
(8) Allergy, hypersensitivity or medical contraindication to either medication
(9) Chronic pain requiring opioid pain management
(10) On daily stable methadone or buprenorphine (SL-B) maintenance every day for past 30 days prior to incarceration or monthly XR-NTX or XR-BUP 30 days or longer prior to incarceration AND intending to remain on same form of methadone or buprenorphine or XR-NTX maintenance now and upon return to the community (i.e., was in MOUD treatment pre-incarceration, on same MOUD treatment now, and plans to continue same MOUD treatment post-incarceration). (Note - If community-dwelling, already on non-study methadone, buprenorphine, or naltrexone for 30 days or longer at the time of enrollment, and planning on continuing same.)
Non-randomized TAU Exclusions:
Currently treated with non-study MOUD while currently incarcerated and for 30+ days prior to incarceration, or, if community-dwelling, currently on MOUD for 30 days or longer at the time of enrollment.

Where it is running

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

Full record on ClinicalTrials.gov

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