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NOT YET RECRUITING
NCT07909408
PHASE2

Psilocybin FCR Early-Stage Breast Cancer

Sponsor: NYU Langone Health

View on ClinicalTrials.gov

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

DRUG

Psilocybin 25 mg

Experimental dose

DRUG

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