Psilocybin-Assisted Psychotherapy for Fear of Cancer Recurrence
This study is exploring whether psilocybin, a substance that affects brain chemicals, combined with psychotherapy can help women with early-stage breast cancer or late-stage ovarian cancer who are in remission and experiencing fear of their cancer returning. The study aims to see if this treatment improves fear of recurrence, anxiety, depression, and overall quality of life. You would participate in therapy sessions, receive a dose of psilocybin in a supervised setting, and complete surveys. The study plans to enroll 20 women and is currently unclear about its recruitment status.
- Study design
- This is an interventional study with a planned enrollment of 20 women.
- What's involved
- You would complete survey measures, participate in preparatory therapy, receive a single dose of psilocybin, and then complete 4 sessions of integrative therapy.
- Compensation
- Not stated in the trial record.
- Follow-up
- You would be followed for 24 weeks after treatment, with assessments at 1, 4, 8, 12, and 24 weeks.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
NCT06430541
Study of Psilocybin Assisted Psychotherapy to Address Fear of Recurrence
Recruiting
PHASE1Ages 21+InterventionalSupportive careUniversity of Colorado, DenverInvestigator-initiated
~20 participants
Updated 2026-04-21 on ClinicalTrials.gov
What's tested:Psilocybin
At a glance
Recruiting sites
2 of 2 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Change in Fear of Cancer Recurrence Inventory
Measured over 1-week, 4-weeks, 8-weeks* (primary outcome time point), 12-weeks, and 24-weeks.
Conditions
Where it's being run
2 sites across 1 statesColorado2
Study leadership
- Stacy Fischer, MD · PRINCIPAL_INVESTIGATOR · University of Colorado, Denver
Who to contact
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Do you actually qualify for this trial?
Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.
Eligibility criteria
Inclusion
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.
Exclusion
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 2. Risk for hypertensive crisis defined as:
Primary or secondary cerebral neoplasm
Epilepsy
History of stroke
Cerebral aneurysm
Dementia
Delirium 4. Primary psychotic or affective psychotic disorders Examples include current or past DSM-5 criteria for:
Schizophrenia spectrum disorders
Schizoaffective disorder
Bipolar I or bipolar II disorder
Major Depressive Disorder with psychotic features
Prior history of psychosis due to medical condition or substance use 5. Family history of psychotic or serious bipolar spectrum illnesses.
Schizophrenia spectrum disorders
Schizoaffective disorder
Bipolar I disorder with psychotic features 6. High risk of adverse emotional or behavioral reaction based on investigator's clinical evaluation and judgement. Examples include:
Agitation
Violent behavior 7. Active substance use disorders (SUDs) defined as:
DSM-5 criteria for moderate or severe alcohol or drug use disorder (excluding caffeine and nicotine) within the past year
DAST-10 score of 3 or higher
Two or more "yes" responses to CAGE screening questionnaire 8. Extensive use of serotonergic hallucinogens (e.g., LSD, psilocybin) defined as:
Any use in the last 12 months
\>25 lifetime uses 9. Clinically significant suicidality or high risk of completed suicide defined as:
'Yes' to C-SSRS Suicidal Ideation items 4 or 5 within the last 2 months at Screening or 'since last visit' at Baseline
Any C-SSRS Suicidal Behavior item within the past 12 months at Screening or 'since last visit' at Baseline, as defined by 'Yes' to any of the following on the C-SSRS: actual attempt, interrupted attempt, aborted attempt, or preparatory acts
Have any suicidal ideation or thoughts, in the opinion of the study physician or PI, that presents a serious risk of suicidal or self-injurious behavior 10. History of hallucinogen persisting perception disorder (HPPD) 11. Pregnancy/lactation 12. Cognitive impairment as defined by:
Antidepressants
Centrally-acting serotonergic agents (e.g., MAO inhibitors)
Serotonin-acting dietary supplements (such as 5-hydroxy-tryptophan or St. John's wort)
Antipsychotics (e.g., first and second generation)
Mood stabilizers (e.g., lithium, valproic acid)
Aldehyde dehydrogenase inhibitors (e.g., disulfiram)
Significant inhibitors of UGT 1A0 or UGT
Efavirenz 14. Have a positive urine drug test including Amphetamines, Barbiturates, Buprenorphine, Benzodiazepines, Cocaine, Cannabis, Methamphetamine, MDMA, Methadone, Opiates (Morphine, Oxycodone) unless prescribed, and Phencyclidine (PCP). 15. Have a psychiatric condition judged to be incompatible with establishment of rapport with the study therapists or safe exposure to psilocybin 16. Have any psychological or physical symptom, medication, or other relevant finding , based on the clinical judgment of the PI or relevant clinical study staff that would make a participant unsuitable for the study. 17. Have an allergy or intolerance to any of the materials contained in the drug product 18. Non-English speaking individual 19. Be enrolled in another clinical trial assessing intervention(s) for anxiety, depression, and/or existential distress (e.g., pharmacologic or psychotherapeutic interventions)
What this trial measures
- Change in Fear of Cancer Recurrence Inventory1-week, 4-weeks, 8-weeks* (primary outcome time point), 12-weeks, and 24-weeks.
Measured by change in core on the Fear of Recurrence Inventory completed at screening and baseline. The FCRI's total score ranges from 0 to 36, with higher scores indicating greater FCR severity.