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

• Status: Recruiting
• Trial end date: 2024-04-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: NYU Langone Health
• Collaborator: National Institute on Drug Abuse (NIDA)
• Treatments: Analgesics, Opioid; Buprenorphine; Naltrexone

Criteria

Inclusion Criteria:

XR-B vs. XR-NTX Inclusions:

1. Adult volunteer aged 18-65yo 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)

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.

5. Willing to accept either XR-B or XR-NTX assignment.

Non-randomized TAU Inclusions:

1. 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)

2. Adult volunteer aged 18-65yo able to provide written informed consent in English or Spanish

3. Current CJS incarceration with pending release date

4. Current or history of moderate-to-severe opioid use disorder in the past year prior to incarceration (OUD, DSM-5)

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:

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 one month prior to incarceration AND intending to remain on methadone or buprenorphine or XR-NTX maintenance upon return to the community.

Non-randomized TAU Exclusions:

6. 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 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.