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Not yet recruitingPhase 2

Psilocybin FCR Early-Stage Breast Cancer

NCT07909408 · NYU Langone Health

Closed to entry
Status
Not accepting participants
Phase 2
Phase
100
Target enrolment
2
Study sites
2 US states

What it is testing

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.

Summary as written by the trial’s own sponsor and published on ClinicalTrials.gov API v2. It is the sponsor’s description, reproduced unedited, not an assessment by this site.

What counts as success

Primary outcome measures

  • Fear of Cancer Recurrence Inventory-Short Form (FCRI-SF)

    Measured over Baseline, Week 4 Post-Dose Session

A trial succeeds or fails on its primary outcome, declared in advance. Everything else it reports is secondary by definition.

Who can take part

Eligibility, as published

21 Years
Ages
FEMALE
Sex
Not accepted
Healthy volunteers
Inclusion Criteria: * Aged ≥ 21 * Females * Diagnosis of Stage 1 or 2 Estrogen/Progesterone Receptor-Positive (ER/PR +), Human Epidermal growth factor Receptor 2 negative (HER2-) breast cancer * Having completed initial treatment (e.g. surgery, chemotherapy, radiotherapy) for breast cancer (ongoing adjuvant endocrine, and/or HER2 therapy allowed) * At least 1 year after completing initial treatment * Clinically significant Fear of Cancer Recurrence (FCR) defined as Fear of Cancer Recurrence Inventory (FCRI) \> 20 at Screening * Have an identified support person * Agree to be accompanied home (or to an otherwise safe destination) by the support person, or another responsible party, following dosing * Participants of childbearing potential must agree to practice an effective means of birth control throughout the duration of the study. Exclusion Criteria: * Unstable medical conditions or serious abnormalities of complete blood count, chemistries, or ECG that in the opinion of the study physician would preclude safe participation in the trial. * Risk for hypertensive crisis defined as Screening, Baseline, and Medication Session (prior to dosing) BP \>160/100, HR \>110 bpm * Significant central nervous system (CNS) pathology. * Primary psychotic or affective psychotic disorders. * Family history of first-degree relative with psychotic or serious bipolar spectrum illnesses. * Clinically significant suicidality or high risk of completed suicide. * History of hallucinogen persisting perception disorder (HPPD) * Pregnancy/lactation * Concurrent Medications * Psychotherapy * Have any psychological or physical symptom, medication or other relevant finding prior to randomization, based on the clinical judgment of the PI or relevant clinical study staff that would make a participant unsuitable for the study. * Be enrolled in another clinical trial assessing intervention(s) for anxiety, depression, and/or existential distress (e.g., pharmacologic or psychotherapeutic interventions)

Where

2 study sites

FacilityCityRegionCountry
University of Colorado Anschutz Medical Campus (CUAMC)AuroraColoradoUnited States
NYU Langone HeathNew YorkNew YorkUnited States

On the registry

Contact the trial directly

This site does not enrol anyone and is not involved in this trial. To ask about taking part, use the sponsor’s own contact details on the official registry record. The registry also holds the most current version of everything above.

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NCT07909408 on ClinicalTrials.gov →

Last updated in the registry 2026-11-02. Registry records change; this page reflects the data build of 2026-11-03.

Related

Where this trial sits