Not Yet RecruitingPhase 2psilocybin

Psilocybin FCR Early-Stage Breast Cancer

Sponsored by NYU Langone Health

NCT ID
NCT07909408
Target Enrollment
100 participants
Start Date
2027-01-02
Est. Completion
2031-08-31

About This Study

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.

Conditions Studied

Early-stage Breast CancerFear of Cancer RecurrenceAnxietyDepression

Interventions

  • •Psilocybin 25 mg
  • •Psilocybin 5 mg

Eligibility

Sex:FEMALE
Age:21 Years - N/A
Healthy Volunteers:No
View full eligibility criteria
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)

Study Locations (2)

University of Colorado Anschutz Medical Campus (CUAMC)
Aurora, Colorado, United States
NYU Langone Heath
New York, New York, United States

Interested in this trial?

Contact the study team to learn more about eligibility and enrollment.

View on ClinicalTrials.gov
Data Source
ClinicalTrials.gov

Last updated from source