Clinical Trial

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

Study acronym: COMBO
Recruiting Phase 2/3
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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.
Protocol Amendment History 11 amendments
This ClinicalTrials.gov record has been amended 11 times since 2021-08-16; most recent amendment 2026-05-15.
Status change: Not Yet Recruiting → Recruiting 2022-08-11
Trial Details
NCT Number NCT05011266
Lead Sponsor New York State Psychiatric Institute
Collaborators: National Institute on Drug Abuse (NIDA)
Conditions Opioid-use Disorder
Enrollment 180 participants
Start Date 2023-04-18
Primary Completion 2027-01-01 (estimated)
Study Completion 2027-01-01 (estimated)
Updated on ClinicalTrials.gov 2026-05-19