Psilocybin for Opioid Use Disorder (OUD)
This is a double-blind, adaptive, 2-stage, multi-site, phase 2 randomized controlled clinical trial designed to evaluate effects of moderate and high dose psilocybin, relative to low-dose psilocybin control, in OUD patients who continue to use illicit opioids in spite of adherence to standard-of-care treatment with methadone. (The sponsor's summary, shortened.)
Eligibility and contacts on ClinicalTrials.govThe registry record
- Status
- Recruiting
- Phase
- Phase 2
- Conditions
- Opioid Use Disorder
- Intervention
- Psilocybin
- Sponsor
- NYU Langone Health
- Ages
- 18 Years to 65 Years
- Sex
- All
- Healthy volunteers
- No
- Enrolment
- 480 people (planned)
- Start
- 17 December 2025
- Primary completion
- February 2029
- Registry last updated
- 23 January 2026
Sites (5)
- Duke City Recovery Toolbox, Albuquerque, New Mexico, United States (recruiting)
- University of New Mexico, Albuquerque, New Mexico, United States (recruiting)
- StartCare, Brooklyn, New York, United States (recruiting)
- NYU Langone Health, New York, New York, United States (recruiting)
- VIP Community Services, Inc, The Bronx, New York, United States (recruiting)
How joining a trial works
- Free to take part
- Trials generally cost participants nothing for the study drug and the study visits, and some pay for travel or time. Check what a study covers on its registry page.
- Screened first
- Every study screens volunteers with questionnaires, medical history and often a physical and psychiatric check. Many people who apply are not enrolled.
- Eligibility is strict
- Common exclusions include a personal or family history of psychosis or bipolar disorder, some heart conditions, pregnancy and certain medications, which you may be asked to stop under medical supervision. Never stop a medication on your own to qualify.
- You may get a placebo
- Many trials compare psilocybin with a placebo or a low dose, and you may not be told which you had until the study ends.
- Contact the study team through the registry
- Each registry record lists the study contacts and sites. We do not republish personal emails or phone numbers; use the link on each trial page.
- Not medical advice
- This is a list of registry records, not a recommendation. Talk to your doctor before applying. Disclaimer · Safety and medications
Source: ClinicalTrials.gov API v2, U.S. National Library of Medicine, read 28 October 2026. Filter: overall status RECRUITING or NOT_YET_RECRUITING; an intervention named psilocybin, psilocin, COMP360 or CYB003. Refreshed weekly; a study's own registry page is always the current record.
Record read from ClinicalTrials.gov API v2, U.S. National Library of Medicine on 28 October 2026. All psilocybin trials