Overview

Efficacy of Buprenorphine and XR-Naltrexone Combination for Relapse Prevention in Opioid Use Disorder

Status:
Not yet recruiting
Trial end date:
2026-06-01
Target enrollment:
Participant gender:
Summary
This study will evaluate the effectiveness of a new pharmacological approach to increase efficacy of treatment with extended release naltrexone (XR-naltrexone) for individuals with opioid use disorder by combining it with buprenorphine-naloxone. This is a two arm, double-blind, placebo-controlled study to examine whether addition of buprenorphine-naloxone will improve treatment retention, reduce opioid craving, and improve mood over 24 weeks of treatment with extended release naltrexone (XR-naltrexone) administered every four weeks for a total of 6 injections.
Phase:
Phase 2/Phase 3
Details
Lead Sponsor:
New York State Psychiatric Institute
Collaborator:
National Institute on Drug Abuse (NIDA)
Treatments:
Buprenorphine
Buprenorphine, Naloxone Drug Combination
Naloxone