Long-acting Buprenorphine vs. Naltrexone for Opioid Use Disorder

Recruiting in Palo Alto (17 mi)

+5 other locations

Overseen byJoshua Lee, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 4

Recruiting

Sponsor: NYU Langone Health

No Placebo Group

Prior Safety Data

Trial Summary

What is the purpose of this trial?

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.

Research Team

Joshua Lee, MD

Principal Investigator

NYU Langone

Eligibility Criteria

This trial is for adults over 18 with opioid use disorder who are currently in the criminal justice system (CJS) and have a release date within 6 months, or were recently involved in CJS. Participants must be willing to take either of the study medications and not plan to move out of state soon. Pregnant individuals, those on certain opioid treatments, with chronic pain needing opioids, allergies to study meds, or severe medical/psychiatric issues cannot join.

Inclusion Criteria

I joined the study before its start or I'm not open to being randomly assigned a treatment but meet other criteria.

You are not planning to move out of state or to new location within 6-months post-release.

Current CJS incarceration with pending release date

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Exclusion Criteria

I do not have any severe mental or liver conditions that make participation unsafe.

I need opioids to manage my chronic pain.

I've been on a stable dose of methadone, buprenorphine, or naltrexone for over 30 days and plan to continue.

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Treatment Details

Interventions

XR-B (SUBLOCADETM) (Opioid Agonist)
XR-NTX (Opioid Antagonist)

Trial OverviewThe trial compares two long-acting medications for treating opioid addiction: extended-release buprenorphine (XR-B) versus extended-release naltrexone (XR-NTX). It aims to see if XR-B is just as effective as XR-NTX at keeping participants on medication after they leave jail or prison. The study will provide data useful for health authorities and policymakers.

Participant Groups

3Treatment groups

Experimental Treatment

Active Control

Group I: extended-release buprenorphine (XR-B)Experimental Treatment1 Intervention

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.

Group II: extended release naltrexone XR-NTXExperimental Treatment1 Intervention

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.

Group III: Treatment as Usual (TAU)Active Control1 Intervention

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.