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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up weeks 4, 8, 12,16, 20, 24, 52
Awards & highlights

Study 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.Check my eligibility
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.See study design
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.

Timeline

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in effectiveness of XR-B versus XR-NTX
Secondary outcome measures
Change in Non-randomized Treatment-As-Usual rates of OUD
Therapeutic procedure
Change in Opioid treatment outcomes - HIV changes
+4 more

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
1,368 Previous Clinical Trials
838,930 Total Patients Enrolled
National Institute on Drug Abuse (NIDA)NIH
2,468 Previous Clinical Trials
2,618,552 Total Patients Enrolled
Joshua Lee, MDPrincipal InvestigatorNYU Langone

Media Library

XR-B (SUBLOCADETM) (Opioid Agonist) Clinical Trial Eligibility Overview. Trial Name: NCT04219540 — Phase 4
Opioid Use Disorder Research Study Groups: extended-release buprenorphine (XR-B), extended release naltrexone XR-NTX, Treatment as Usual (TAU)
Opioid Use Disorder Clinical Trial 2023: XR-B (SUBLOCADETM) Highlights & Side Effects. Trial Name: NCT04219540 — Phase 4
XR-B (SUBLOCADETM) (Opioid Agonist) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04219540 — Phase 4

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are adolescent participants permissible in this experiment?

"This clinical study seeks patients aged 18 to 65 years old."

Answered by AI

What is the participant cap for this experiment?

"Yes, the evidence from clinicaltrials.gov verifies that this medical trial is actively enrolling participants. First published on July 1st 2021 and last updated January 28th 2022, the research aims to enrol 301 patients across six different locations."

Answered by AI

How many clinical sites have been contracted to conduct this trial?

"Participants are being sourced from Dartmouth College in Hanover, New hampshire; Yale University School of Medicine in New Haven, Connecticut; and Rutgers University in New Brunswick, New jersey along with 6 other locations."

Answered by AI

Does the FDA recognize XR-B (SUBLOCADETM) for therapeutic applications?

"Our company has assessed the safety of XR-B (SUBLOCADETM) with a score of 3, signifying that this treatment is approved due to its Phase 4 trial status."

Answered by AI

Am I eligible to partake in this investigation?

"This trial is seeking 301 subjects aged 18 to 65, suffering from opioid abuse. In order for a patient to be eligible they need to meet the specified criteria such as: willing acceptance of either XR-B or XR-NTX assignment, prior recruitment before the RCT launch and no plans on relocating out of state within 6 months post-release along with current CJS incarceration and moderate/severe OUD in the past year."

Answered by AI

How has XR-B (SUBLOCADETM) been typically utilized in patient care?

"XR-B (SUBLOCADETM) is a well-known treatment for chronic weight management, yet it can also offer symptomatic relief from pain, an increase in physical activity levels, and help patients achieve caloric restriction goals."

Answered by AI

What other experiments have been undertaken utilizing XR-B (SUBLOCADETM)?

"XR-B (SUBLOCADETM) first underwent research at Columbia Addiction Services and Psychotherapy Intervention Research in 2007. Currently, 419 studies have been concluded while 80 clinical trials remain open; several of them taking place close to Hanover, New hampshire."

Answered by AI

Is the enrollment window still open for this research endeavor?

"Clinicaltrials.gov attests to the veracity of this trial and its current recruiting status, with an initial posting date of January 7th 2021 and most recent update on January 28th 2022."

Answered by AI

Who else is applying?

What state do they live in?
California
How old are they?
18 - 65
What site did they apply to?
Oregon Health and Science University
What portion of applicants met pre-screening criteria?
Met criteria
Recent research and studies
clinicaltrials.govStudy
Long-acting Buprenorphine vs. Naltrexone Opioid Treatments in CJS-involved Adults
2021. "Long-acting Buprenorphine vs. Naltrexone Opioid Treatments in CJS-involved Adults". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04219540.
All > Opioid Dependence > Probuphine
~19 spots leftby Jun 2024
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