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

Last updated: June 20, 2024
Sponsor: NYU Langone Health
Overall Status: Active - Recruiting

Phase

4

Condition

Opioid Use Disorder

Treatment

XR-NTX

XR-B (SUBLOCADETM)

Clinical Study ID

NCT04219540
19-01450
  • Ages > 18
  • All Genders

Study Summary

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

XR-B vs. XR-NTX Inclusions:

  • (1) Adult volunteer aged 18 years or older able to provide written informed consentin English (or Spanish at some sites)

  • (2) Current CJS incarceration (residing in a controlled environment) with pendingrelease date (within 6 months of randomization) OR community CJS-involvement definedas: a) Current CJS incarceration (residing in a controlled environment) with pendingrelease date (within 6 months of anticipated randomization), or; b)Community-dwelling volunteers with current CJS-involvement. [Current CJS-involvementis defined as either 1) release from any CJS incarceration or detention, or 2) undercommunity supervision (includes parole, probation, drug or other treatment court, orother alternative to incarceration supervision) within 6 months prior to studyenrollment (the date of a signed ICF)].

  • (3) Current or history of moderate-to-severe opioid use disorder in the past yearprior to incarceration (OUD, DSM-5)

  • (4) Not planning to move out of state or to new location within 6-monthspost-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).

Exclusion

Exclusion Criteria:

XR-B vs. XR-NTX Exclusions:

  • (6) Medical or psychiatric disorders making participation unsafe or regularfollow-up unlikely, (such as suicidal ideation or pre-existing moderate to severehepatic 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 forpast 30 days prior to incarceration or monthly XR-NTX or XR-BUP 30 days or longerprior to incarceration AND intending to remain on same form of methadone orbuprenorphine or XR-NTX maintenance now and upon return to the community (i.e., wasin MOUD treatment pre-incarceration, on same MOUD treatment now, and plans tocontinue same MOUD treatment post-incarceration). (Note - If community-dwelling,already on non-study methadone, buprenorphine, or naltrexone for 30 days or longerat 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.

Study Design

Total Participants: 796
Treatment Group(s): 2
Primary Treatment: XR-NTX
Phase: 4
Study Start date:
January 07, 2021
Estimated Completion Date:
December 15, 2024

Study Description

Participants eligible for randomization will be randomized 1:1 to extended-release buprenorphine (XR-B) vs. extended-release naltrexone (XR-NTX) prior to release from the correctional controlled environment (including jails, prisons, work release and residential treatment, or other correctional facilities) and treated for 24-weeks following release or upon entry into a community CJS-mandated program.

XR-B (SublocadeTM, Indivior) is a partial opioid agonist indicated for the treatment of moderate to severe opioid use disorder. Delivered as a pre-filled 2cc subcutaneous monthly injection, typically using two 300mg/1.5 ml initial starting doses followed by 100mg/0.5 ml monthly maintenance doses. The study will provide up to six monthly XR-B doses throughout the study. Prior to an initial injection, the participant must be stable for seven days or longer on sublingual buprenorphine (SLB) at doses of 8mg/day or higher.

Description of Study Intervention Participants eligible for randomization (n=670) will be randomized 1:1 to extended-release buprenorphine (XR-B) vs. extended-release naltrexone (XR-NTX) prior to release from the correctional controlled environment (including jails, prisons, work release and residential treatment, or other correctional facilities) and treated for 24-weeks following release or upon entry into a community CJS-mandated program.

XR-B (SublocadeTM, Indivior) is a partial opioid agonist indicated for the treatment of moderate to severe opioid use disorder. Delivered as a pre-filled 2cc subcutaneous monthly injection, typically using two 300mg/1.5 ml initial starting doses followed by 100mg/0.5 ml monthly maintenance doses. The study will provide up to six monthly XR-B doses throughout the study. Prior to an initial injection, the participant must be stable for seven days or longer on sublingual buprenorphine (SLB) at doses of 8mg/day or higher.

XR-NTX (Vivitrol®, Alkermes) is an opioid antagonist indicated for the prevention of opioid dependence, following detoxification. A negative opioid urine toxicology, negative self-report of any recent opioid use, and a naloxone challenge. The naloxone challenge consists of 0.4-0.8mg of IV/SC/IM naloxone followed by the observation of no opioid withdrawal symptoms, or the use of oral naltrexone (12.5-25mg) followed by 1-2 hours of observation. XR-NTX is delivered as a 380mg (4cc) intramuscular injection to the upper outer gluteus (buttock) monthly. The study will provide six or more monthly XR-NTX doses.

Connect with a study center

  • Yale University School of Medicine

    New Haven, Connecticut 06510
    United States

    Active - Recruiting

  • Friends Research Institute

    Baltimore, Maryland 21201
    United States

    Active - Recruiting

  • Dartmouth College

    Hanover, New Hampshire 03755
    United States

    Active - Recruiting

  • Rutgers University

    New Brunswick, New Jersey 08901
    United States

    Active - Recruiting

  • NYU Langone Health

    New York, New York 10016
    United States

    Active - Recruiting

  • Oregon Health and Science University

    Portland, Oregon 97219
    United States

    Active - Recruiting

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