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Study identifier: NCT05011266 Synced from ClinicalTrials.gov · July 29, 2026
● Recruiting

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

Condition: Opioid-use Disorder  ·  Sponsor: New York State Psychiatric Institute

PhasePhase 2/Phase 3
Planned participants180
Who can joinAll sexes, 18 Years to 65 Years
Healthy volunteersNo

About this study

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.

This description comes directly from the study's public registry record.

Talk to the study team

Adam Bisaga, MD  ·  646-774-6155  ·  amb107@columbia.edu

Onumara Opara, MPH  ·  onumara.opara@nyspi.columbia.edu

Always discuss trial participation with your own doctor first.

Locations (2)

Avery Road Treatment Center (ARTC)Rockville, Maryland, United StatesRecruiting
Stars/NyspiNew York, New York, United StatesTerminated

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Source record: clinicaltrials.gov/study/NCT05011266