Long-acting Buprenorphine vs. Naltrexone Opioid Treatments in CJS-involved Adults
Opioid-use Disorder
About this trial
This is an interventional treatment trial for Opioid-use Disorder
Eligibility Criteria
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.
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.
Sites / Locations
- Yale University School of MedicineRecruiting
- Friends Research InstituteRecruiting
- Dartmouth CollegeRecruiting
- Rutgers UniversityRecruiting
- NYU Langone HealthRecruiting
- Oregon Health and Science UniversityRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Experimental
Experimental
No Intervention
extended-release buprenorphine (XR-B)
extended release naltrexone XR-NTX
Treatment as Usual (TAU)
Subjects who agree to XR-B treatment will receive an XR-B injection to the abdomen. The injection is a liquid medication in the amount of either 100 or 300 mg buprenorphine in 1.5 cc volume and will last in the body for about 30 days. The medication is stored in a small nodule under the skin of the belly where it was injected. The buprenorphine is gradually released into the body over time for a 30-day period.
Subjects who agree to XR-NTX treatment will receive an injection of XR-NTX to the outer upper part of your buttock. The injection is a liquid medication in the amount of 380 mg naltrexone in 4 cc volume (about 1 teaspoon) and will last in your body for about 30 days. Following release, visits with study physicians at Bellevue Hospital will offer further counseling or medication treatment referrals, the option to receive additional XR-NTX injections once a month following the first injection and continued encouragement to avoid relapses and stay on treatment.
In this group you will not receive any study medication. You will be able to receive any treatments available to individuals in the jail or prison who are not in the study. Trained study staff at the first two visits will provide counseling focusing on relapse and overdose prevention, treatment engagement, and navigating re-entry challenges.