Study of Psilocybin Assisted Psychotherapy to Address Fear of Recurrence
Recruiting now · Phase 1
Conditions studied: Breast Cancer, Ovarian Cancer
In brief
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.
Key facts
- Study ID
- NCT06430541
- Run by
- University of Colorado, Denver
- People needed
- 20
- Starts
- 2024-11-21
- Expected to finish
- 2028-12-01
- Last updated by the study team
- 2026-04-21
Who can join
Age: 21 and older. Sex: female. Healthy volunteers: not accepted.
You may qualify if…
- 1, Aged ≥ 21 2. Diagnosis of:
- early-stage breast cancer at low risk of recurrence
- defined as clinical stage 1 or 2
- completed primary treatment (surgery, chemotherapy [adjuvant, patients may continue to be treated with neoadjuvant], and/or radiation) > 6 months ago
- oncologist reported risk of recurrence at 10 years < 20%
- late-stage ovarian cancer at high risk of recurrence
- defined as Clinical stage 3 or 4
- currently in remission
- oncologist reported risk of recurrence at 10 years > 80% 2. Functional Status defined as:
- Eastern Cooperative Oncology Group (ECOG) ≤1
- Palliative Performance Scale (PPS) ≥60%
- Ability to tolerate PO medication administration 4. Fear of recurrence at screening and baseline 5. 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 6. Participants of childbearing potential must agree to practice an effective means of birth control throughout the duration of the study.
You may not qualify if…
- 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
- Risk for hypertensive crisis defined as:
- Screening and Baseline blood pressure >140/90 mmHg
- Significant central nervous system (CNS) pathology
- Examples include:
- Primary or secondary cerebral neoplasm
- Epilepsy
- History of stroke
- Cerebral aneurysm
- Dementia
- Delirium
Where it is running
- Outpatient CTRC — Aurora, Colorado, United States (enrolling)
- University of Colorado Cancer Center — Aurora, Colorado, United States (enrolling)
Full record on ClinicalTrials.gov
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