Not yet recruitingPhase 2NCT07909408
Psilocybin FCR Early-Stage Breast Cancer
This trial is designed to evaluate efficacy and psychological mechanisms of single-dose psilocybin-assisted psychotherapy (PAP) to treat fear of cancer recurrence (FCR), psychiatric (anxiety, depression) distress and quality-of-life (QOL), in 100 outpatients with early-stage breast cancer. (The sponsor's summary, shortened.)
Eligibility and contacts on ClinicalTrials.govThe registry record
- Status
- Not yet recruiting
- Phase
- Phase 2
- Conditions
- Early-stage Breast Cancer; Fear of Cancer Recurrence; Anxiety; Depression
- Intervention
- Psilocybin 25 mg; Psilocybin 5 mg
- Sponsor
- NYU Langone Health
- Ages
- 21 Years and over
- Sex
- Female
- Healthy volunteers
- No
- Enrolment
- 100 people (planned)
- Start
- 2 January 2027
- Primary completion
- 2 January 2031
- Registry last updated
- 2 November 2026
Sites (2)
- University of Colorado Anschutz Medical Campus (CUAMC), Aurora, Colorado, United States
- NYU Langone Heath, New York, New York, United States
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 3 November 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 3 November 2026. All psilocybin trials