Long-acting Buprenorphine vs. Naltrexone Opioid Treatments in CJS-involved Adults

NCT04219540 | Completed Phase 4 DMC FDA Drug

• 1 other identifier: 19-01450
• Study Type: interventional
• Target: 675
• Locations: 1 country
• Sites: 6

Brief Summary

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.

Conditions

Opioid-use Disorder

Outcome Measures

Primary Outcomes (1)

• Number of Injections during 24-Week Post-Release Treatment Phase

  The primary outcome measure is retention-in-study-medication-treatment post-release during weeks 1-24; retention is defined as the proportion of scheduled study medication injections received. The total score ranges from 0-6 and is scored as following: less than 6 XR-B injections will contribute to lower retention (\<5 of 6), and 7+ XR-NTX will contribute only to maximum retention (6 of 6).

  Up to Week 24

Secondary Outcomes (7)

• Change in Opioid use

  Weeks 0, 4, 8, 12,16, 20, 24, 52

• Change in Opioid treatment outcomes - adverse events

  Weeks 0, 4, 8, 12,16, 20, 24, 52

• Change in Opioid treatment outcomes - lifestyle changes

  Weeks 0, 4, 8, 12,16, 20, 24, 52

• Change in Opioid treatment outcomes - HIV changes

  Weeks 0, 24

• Change in criminal justice system (CJS) involvement with XR-B versus XR-NTX

  Weeks 4, 8, 12,16, 20, 24, 52

Study Arms (3)

extended-release buprenorphine (XR-B)

EXPERIMENTAL

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.

Drug: XR-B (SUBLOCADETM)

extended release naltrexone XR-NTX

EXPERIMENTAL

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.

Drug: XR-NTX

Treatment as Usual (TAU)

NO 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.

Interventions

XR-B (SUBLOCADETM) DRUG

XR-B (SUBLOCADETM) contains buprenorphine, a partial opioid agonist, and is indicated for the treatment of moderate to severe opioid use disorder in patients who have initiated treatment with a transmucosal buprenorphine-containing product, followed by dose adjustment for a minimum of 7 days. Following induction and dose adjustment with sublingual buprenorphine, the recommended starting dose is 300 mg monthly for the first two months followed by a maintenance dose of 100 mg monthly thereafter. XR-B is administered monthly only by subcutaneous injection in the abdominal region. Study clinical staff will have flexibility to continue the 300mg dose for greater than 2 months, or use the 100mg dose for initial induction, if the participant's opioid use history or clinical status at the time of dosing support these decisions.

Also known as: SUBLOCADE TM

extended-release buprenorphine (XR-B)

XR-NTX DRUG

XR-NTX (Vivitrol®) produces a 30-day mu opioid receptor antagonist blockade Induction procedures require detoxification off opioids (5-7 days since last opioid use), a negative opioid urine toxicology, negative self-report of any recent opioid use, and a naloxone challenge. The naloxone challenge consists of 0.4-0.8mg of IV/SC/IM naloxone followed by the observation of no opioid withdrawal symptoms, or the use of oral naltrexone (12.5-25mg) followed by 1-2 hours of observation. XR-NTX is then delivered as a 380mg (4cc) intramuscular injection to the upper outer gluteus (buttock). Study interventions are FDA-approved, used in accordance with FDA-labeling and will be administered by a study clinician

Also known as: Vivitrol®

extended release naltrexone XR-NTX

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• (1) Adult volunteer aged 18 years or older able to provide written informed consent in English (or Spanish at some sites)
• (2) Current CJS incarceration (residing in a controlled environment) with pending release date (within 6 months of randomization) OR community CJS-involvement defined as: a) Current CJS incarceration (residing in a controlled environment) with pending release date (within 6 months of anticipated randomization), or; b) Community-dwelling volunteers with current CJS-involvement. \[Current CJS-involvement is defined as either 1) release from any CJS incarceration or detention, or 2) under community supervision (includes parole, probation, drug or other treatment court, or other alternative to incarceration supervision) within 6 months prior to study enrollment (the date of a signed ICF)\].
• (3) Current or history of moderate-to-severe opioid use disorder in the past year prior to incarceration (OUD, DSM-5)
• (4) Not planning to move out of state or to new location within 6-months post-release (reasonable chance they can complete 6 months of follow-up visits).
• (5) Willing to accept either XR-B or XR-NTX assignment.

You may not qualify if:

• (6) Medical or psychiatric disorders making participation unsafe or regular follow-up unlikely, (such as suicidal ideation or pre-existing 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 30 days or longer prior to incarceration AND intending to remain on same form of methadone or buprenorphine or XR-NTX maintenance now and upon return to the community (i.e., was in MOUD treatment pre-incarceration, on same MOUD treatment now, and plans to continue same MOUD treatment post-incarceration). (Note - If community-dwelling, already on non-study methadone, buprenorphine, or naltrexone for 30 days or longer at the time of enrollment, and planning on continuing same.)
• Currently treated with non-study MOUD while currently incarcerated and for 30+ days prior to incarceration, or, if community-dwelling, currently on MOUD for 30 days or longer at the time of enrollment.

Sponsors & Collaborators

• NYU Langone Health: lead
• National Institute on Drug Abuse (NIDA): collaborator

Study Sites (6)

Yale University School of Medicine

New Haven, Connecticut, 06510, United States

Location

Friends Research Institute

Baltimore, Maryland, 21201, United States

Location

Dartmouth College

Hanover, New Hampshire, 03755, United States

Location

Rutgers University

New Brunswick, New Jersey, 08901, United States

Location

NYU Langone Health

New York, New York, 10016, United States

Location

Oregon Health and Science University

Portland, Oregon, 97219, United States

Location

MeSH Terms

Conditions

Opioid-Related Disorders

Interventions

vivitrol

Condition Hierarchy (Ancestors)

Narcotic-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Study Officials

• Joshua Lee, MD

  NYU Langone

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 26, 2019
• First Posted: January 7, 2020
• Study Start: January 7, 2021
• Primary Completion: August 1, 2024
• Study Completion: February 28, 2025
• Last Updated: May 14, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Immediately following publication. No end date.
• Access Criteria: Researchers who provide a methodologically sound proposal. Upon reasonable request. Requests should be directed to mia.malone@nyulangone.org. To gain access, data requestors will need to sign a data access agreement.

Locations

US (6)