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Not yet recruiting Phase 2 Interventional

Psilocybin FCR Early-Stage Breast Cancer

ClinicalTrials.gov ID: NCT07909408

Public ClinicalTrials.gov record NCT07909408. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Nov 3, 2026, 5:59 AM EST

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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.

Study identification

NCT ID
NCT07909408
Recruitment status
Not yet recruiting
Study type
Interventional
Phase
Phase 2
Lead sponsor
NYU Langone Health
Other
Enrollment
100 participants

Conditions and interventions

Eligibility (public fields only)

Age range
21 Years and older
Sex
Female
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Jan 2, 2027 (Estimated)
Primary completion
Jan 2, 2031 (Estimated)
Completion
Aug 31, 2031 (Estimated)
Last update posted
Nov 2, 2026

2027 – 2031

United States locations

U.S. sites
2
U.S. states
2
U.S. cities
2
Facility City State ZIP Site status
University of Colorado Anschutz Medical Campus (CUAMC) Aurora Colorado 80045 —
NYU Langone Heath New York New York 10016 —

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT07909408, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Nov 2, 2026 · Synced Nov 3, 2026

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Open the official record

The complete public registry record, listed eligibility criteria, and available contact information for NCT07909408 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →