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

PHASE4CompletedINTERVENTIONAL
Enrollment

675

Participants

Timeline

Start Date

January 7, 2021

Primary Completion Date

August 1, 2024

Study Completion Date

February 28, 2025

Conditions
Opioid-use Disorder
Interventions
DRUG

XR-B (SUBLOCADETM)

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.

DRUG

XR-NTX

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

Trial Locations (6)

10016

NYU Langone Health, New York

21201

Friends Research Institute, Baltimore

97219

Oregon Health and Science University, Portland

06510

Yale University School of Medicine, New Haven

03755

Dartmouth College, Hanover

08901

Rutgers University, New Brunswick

All Listed Sponsors
collaborator

National Institute on Drug Abuse (NIDA)

NIH

lead

NYU Langone Health

OTHER

NCT04219540 - Long-acting Buprenorphine vs. Naltrexone Opioid Treatments in CJS-involved Adults | Biotech Hunter | Biotech Hunter