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Opioid Agonist

Long-acting Buprenorphine vs. Naltrexone for Opioid Use Disorder

Phase 4

Recruiting

Led By Joshua Lee, MD

Research Sponsored by NYU Langone Health

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Must not have

Medical or psychiatric disorders making participation unsafe or regular follow-up unlikely, (such as suicidal ideation or pre-existing moderate to severe hepatic impairment)

Chronic pain requiring opioid pain management

Timeline

Screening 3 weeks

Treatment Varies

Follow Up weeks 4, 8, 12,16, 20, 24, 52

Awards & highlights

Drug Has Already Been Approved

No Placebo-Only Group

Pivotal Trial

Summary

This trial will 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.

Who is the study for?

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.

What is being tested?

The 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.

What are the potential side effects?

Possible side effects from these medications include nausea, headache, dizziness, fatigue, injection site reactions for XR-B; and potential withdrawal symptoms when starting treatment with XR-NTX. Each person's experience may vary.

Eligibility Criteria

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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

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I need opioids to manage my chronic pain.

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I am allergic or have a bad reaction to certain medications.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ weeks 4, 8, 12,16, 20, 24, 52

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~weeks 4, 8, 12,16, 20, 24, 52

This trial's timeline: 3 weeks for screening, Varies for treatment, and weeks 4, 8, 12,16, 20, 24, 52 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change in effectiveness of XR-B versus XR-NTX

Secondary study objectives

Change in Non-randomized Treatment-As-Usual rates of OUD

Therapeutic procedure

Change in Opioid treatment outcomes - HIV changes

+4 more

Awards & Highlights

Drug Has Already Been Approved

The FDA has already approved this drug, and is just seeking more data.

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

XR-NTX

2015

Completed Phase 3

~460

0 / 3Eligibility criteria met