OncoMatch/Clinical Trials/NCT06430541
Study of Psilocybin Assisted Psychotherapy to Address Fear of Recurrence
Is NCT06430541 recruiting? Yes, currently enrolling (May 2026). This Phase 1 trial studies Psilocybin for breast cancer.
Treatment: Psilocybin — The goal of this clinical trial is to test whether psilocybin along with therapy in women with early breast cancer and ovarian cancer in remission can improve their fear of recurrence. The main question\[s\] it aims to answer \[is/are\]: Does psilocybin assisted therapy improve fear of cancer recurrence? Does psilocybin assisted therapy improve anxiety, depression, and quality of life? Participants will complete a series of survey measures, participate in preparatory therapy. After prep therapy is complete, they will receive a moderately high dose of psilocybin in a monitored and supportive environment. After the dosing day, they will complete 4 sessions of integrative therapy and complete survey measures.
Check if I qualifyExtracted eligibility criteria
Cancer type
Breast Carcinoma
Ovarian Cancer
Disease stage
Required: Stage I, II, III, IV (clinical)
clinical stage 1 or 2 (breast); Clinical stage 3 or 4 (ovarian)
Performance status
ECOG 0–1(Restricted strenuous activity)
Eastern Cooperative Oncology Group (ECOG) ≤1
Prior therapy
Must have received: surgery — primary
completed primary treatment (surgery, chemotherapy [adjuvant, patients may continue to be treated with neoadjuvant], and/or radiation) > 6 months ago
Must have received: chemotherapy — adjuvant or neoadjuvant
completed primary treatment (surgery, chemotherapy [adjuvant, patients may continue to be treated with neoadjuvant], and/or radiation) > 6 months ago
Must have received: radiation therapy — primary
completed primary treatment (surgery, chemotherapy [adjuvant, patients may continue to be treated with neoadjuvant], and/or radiation) > 6 months ago
Lab requirements
Blood counts
WBC < 5 x 10^9/L, Hemoglobin < 8.0 g/dL, Platelets < 150 x 10^9/L excluded
Kidney function
Acute renal failure excluded; eGFR < 50 mL/min/1.73m2 excluded
Liver function
Severe hepatic impairment excluded; LFTs > 1.5 x ULN excluded
Cardiac function
Congestive heart failure, valvular heart disease, clinically significant arrhythmias, QTC interval > 450, recent acute myocardial infarction, evidence of ischemia, malignant hypertension, congenital long QT syndrome excluded
Unstable medical conditions or serious abnormalities of complete blood count, chemistries, or EKG that in the opinion of the study physician would preclude safe participation in the trial. Some examples include: Congestive heart failure, Valvular heart disease, Clinically significant arrhythmias (e.g., ventricular fibrillation, torsades) or clinically significant EKG abnormality (i.e., QTC interval > 450), Recent acute myocardial infarction or evidence of ischemia, Malignant hypertension, Congenital long QT syndrome, Acute renal failure, Severe hepatic impairment, Respiratory failure, eGFR < 50 mL/min/1.73m2, LFTs > 1.5 x ULN, WBC < 5 x 10^9/L, Hemoglobin < 8.0 g/dL, Platelets < 150 x 10^9/L
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- Outpatient CTRC · Aurora, Colorado
- University of Colorado Cancer Center · Aurora, Colorado
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