Actively Recruiting
Study of Psilocybin Assisted Psychotherapy to Address Fear of Recurrence
Led by University of Colorado, Denver · Updated on 2026-04-21
20
Participants Needed
2
Research Sites
210 weeks
Total Duration
On this page
Sponsors
U
University of Colorado, Denver
Lead Sponsor
U
Usona Institute
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Study of Psilocybin Assisted Psychotherapy to Address Fear of Recurrence
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 21 years or older
- Diagnosed with early-stage breast cancer (clinical stage 1 or 2) at low risk of recurrence with completed primary treatment over 6 months ago and oncologist-reported risk of recurrence under 20%
- Diagnosed with late-stage ovarian cancer (clinical stage 3 or 4), currently in remission, and oncologist-reported risk of recurrence over 80%
- Eastern Cooperative Oncology Group (ECOG) performance status 1 or less
- Palliative Performance Scale (PPS) score 60% or higher
- Able to take oral medication
- Fear of cancer recurrence present at screening and baseline
- Have an identified support person who agrees to accompany you home or to a safe place after dosing
- If of childbearing potential, agree to use effective birth control during the study
You will not qualify if you...
- Unstable medical conditions or serious abnormalities in blood count, chemistries, or EKG that could make participation unsafe (including heart failure, valvular heart disease, significant arrhythmias, recent heart attack, malignant hypertension, congenital long QT syndrome, acute kidney failure, severe liver impairment, respiratory failure, low kidney function, abnormal liver tests, low white blood cells, low hemoglobin, or low platelets)
- Blood pressure over 140/90 mmHg at screening or baseline
- Significant central nervous system problems such as brain tumors, epilepsy, stroke, cerebral aneurysm, dementia, or delirium
- Current or past psychotic disorders including schizophrenia spectrum, schizoaffective disorder, bipolar disorder, major depressive disorder with psychotic features, or psychosis due to medical or substance use
- Family history of serious psychotic or bipolar disorders in a first-degree relative
- High risk of emotional or behavioral reactions like agitation or violent behavior
- Active moderate or severe substance use disorders (excluding caffeine and nicotine) within the past year
- Extensive use of serotonergic hallucinogens including any use in the last 12 months or more than 25 lifetime uses
- Significant suicidal thoughts or behaviors within recent months
- History of hallucinogen persisting perception disorder
- Pregnancy or breastfeeding
- Cognitive impairment with Montreal Cognitive Assessment Test score under 23
- Use of certain medications including antidepressants, serotonergic agents, antipsychotics, mood stabilizers, aldehyde dehydrogenase inhibitors, certain enzyme inhibitors, or efavirenz
- Positive urine drug test for various substances unless prescribed
- Psychiatric conditions that prevent safe therapy or rapport with therapists
- Any psychological or physical condition judged unsuitable by study staff
- Allergy or intolerance to study drug components
- Non-English speaking
- Participation in another clinical trial for anxiety, depression, or existential distress interventions
AI-Screening
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Trial Site Locations
Total: 2 locations
1
Outpatient CTRC
Aurora, Colorado, United States, 80045
Actively Recruiting
2
University of Colorado Cancer Center
Aurora, Colorado, United States, 80045
Actively Recruiting
Research Team
M
Mary Mancuso
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
SUPPORTIVE_CARE
Number of Arms
1
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