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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:Select...
I do not have any severe mental or liver conditions that make participation unsafe.
Select...
I need opioids to manage my chronic pain.
Select...
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
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 moreAwards & 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
Find a Location
Who is running the clinical trial?
NYU Langone HealthLead Sponsor
1,415 Previous Clinical Trials
855,286 Total Patients Enrolled
National Institute on Drug Abuse (NIDA)NIH
2,599 Previous Clinical Trials
3,328,362 Total Patients Enrolled
Joshua Lee, MDPrincipal InvestigatorNYU Langone
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I do not have any severe mental or liver conditions that make participation unsafe.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.I am currently in jail but will be released within the next 6 months.I am eligible for the study but cannot be randomly assigned to a treatment group due to my current methadone treatment.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.I am 18 or older and can give consent in English or Spanish.You have a history of using a lot of opioids and were diagnosed with opioid use disorder in the past year before being put in jail.I am open to being assigned either XR-B or XR-NTX treatment.I am willing to be assigned to either XR-B or XR-NTX treatment.I am allergic or have a bad reaction to certain medications.
Research Study Groups:
This trial has the following groups:- Group 1: extended-release buprenorphine (XR-B)
- Group 2: extended release naltrexone XR-NTX
- Group 3: Treatment as Usual (TAU)
Awards:
This trial has 3 awards, including:- 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.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.