Clinical Research Directory
Browse clinical research sites, groups, and studies.
Psilocybin FCR Early-Stage Breast Cancer
Sponsor: NYU Langone Health
Summary
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 study will assess the strength and durability of therapeutic effects in a double-blind, parallel-design, placebo-controlled, two-center randomized controlled trial (RCT) comparing a single 25mg oral 'high' dose of psilocybin to a single 5mg oral 'low dose psilocybin (active placebo), both delivered in conjunction with a psychotherapy platform.
Key Details
Gender
FEMALE
Age Range
21 Years - Any
Study Type
INTERVENTIONAL
Enrollment
100
Start Date
2027-01-02
Completion Date
2031-08-31
Last Updated
2026-11-02
Healthy Volunteers
No
Interventions
Psilocybin 25 mg
Experimental dose
Psilocybin 5 mg
Active comparator dose
Locations (2)
University of Colorado Anschutz Medical Campus (CUAMC)
Aurora, Colorado, United States
NYU Langone Heath
New York, New York, United States