RecruitingPhase 2 / Phase 3NCT05398484
Psilocybin Therapy in Advanced Cancer
The purpose of this research is to study the safety and effects of single-dose psilocybin 25mg versus an active placebo (single dose niacin 100mg) in the treatment of anxiety, depression, and existential distress (i.e., loss of meaning and hope; fear of death) in advanced cancer (i.e., stage 3 or 4). (The sponsor's summary, shortened.)
Eligibility and contacts on ClinicalTrials.govThe registry record
- Status
- Recruiting
- Phase
- Phase 2 / Phase 3
- Conditions
- Advanced Cancer
- Intervention
- Psilocybin 25 mgs; Niacin 100mg; Psychotherapy
- Sponsor
- NYU Langone Health
- Ages
- 21 Years to 100 Years
- Sex
- All
- Healthy volunteers
- No
- Enrolment
- 200 people (planned)
- Start
- 24 May 2023
- Primary completion
- 1 January 2027
- Registry last updated
- 14 October 2026
Sites (2)
- University of Colorado Anschutz Medical campus (CU AMC), Aurora, Colorado, United States (recruiting)
- NYU Langone Health, New York, 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