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

  • STATUS
    Recruiting
  • End date
    Apr 24, 2024
  • participants needed
    301
  • sponsor
    NYU Langone Health
Updated on 24 March 2022

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.

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.

Details
Condition Opioid-use Disorder
Treatment XR-NTX, XR-B (SUBLOCADETM)
Clinical Study IdentifierNCT04219540
SponsorNYU Langone Health
Last Modified on24 March 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

XR-B vs. XR-NTX Inclusions
Adult volunteer aged 18-65yo able to provide written informed consent in English (or Spanish at some sites)
Current CJS incarceration (residing in a controlled environment) with pending release date (within 6 months of randomization)
Current or history of moderate-to-severe opioid use disorder in the past year prior to incarceration (OUD, DSM-5)
Not planning to move out of state or to new location within 6-months post-release
Willing to accept either XR-B or XR-NTX assignment
Non-randomized TAU Inclusions
Recruited prior to launch of RCT or not willing to randomize to XR-B or XR-NTX assignment, but are otherwise eligible based on inclusion (#2-4) and exclusion below (#6-10)
Adult volunteer aged 18-65yo able to provide written informed consent in English or Spanish
Current CJS incarceration with pending release date
Current or history of moderate-to-severe opioid use disorder in the past year prior to incarceration (OUD, DSM-5)
Not planning to move out of state or to new location within 6-months post-release

Exclusion Criteria

XR-B vs. XR-NTX Exclusions
Medical or psychiatric disorders making participation unsafe or regular follow-up unlikely, (such as suicidal ideation or pre-existing moderate to severe hepatic impairment)
Pregnancy, planning conception, or breast-feeding
Allergy, hypersensitivity or medical contraindication to either medication
Chronic pain requiring opioid pain management
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 one month prior to incarceration AND intending to remain on methadone or buprenorphine or XR-NTX maintenance upon return to the community
Severe medical or psychiatric disorders, such as suicidal ideation or 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
Non-randomized TAU Exclusions
every day for past 30 days prior to incarceration or monthly XR-NTX or XR-BUP one month
prior to incarceration AND intending to remain on methadone or buprenorphine or XR-NTX
maintenance upon return to the community
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