Clinical TrialPalliative & End-of-Life DistressPsilocybinRecruiting

A Phase 1b Study of Psilocybin Assisted Psychotherapy to Address Fear of Recurrence

Phase 1b single-group interventional study (n=20) testing a single 25 mg dose of psilocybin with manualized psychotherapy to reduce fear of cancer recurrence in women with early breast cancer or ovarian cancer in remission.

Target Enrollment
20 participants
Study Type
Phase I interventional
Design
Non-randomized

Detailed Description

This single-group Phase 1b study will assess whether a single 25 mg oral dose of cGMP psilocybin combined with preparatory and integrative psychotherapy reduces fear of cancer recurrence in women previously treated for early breast cancer or ovarian cancer in remission.

Participants complete preparatory therapy, a monitored dosing session, and four integrative therapy sessions; outcomes include measures of fear of recurrence, anxiety, depression, and quality of life.

Safety screening excludes unstable medical conditions, significant CNS pathology, primary psychotic disorders, recent heavy hallucinogen use, active moderate/severe substance use disorder, significant suicidality, pregnancy, and interacting medications.

Study Protocol

Preparation

sessions

Dosing

1 sessions

Integration

4 sessions

Therapeutic Protocol

support

Study Arms & Interventions

Psilocybin + therapy

experimental

25 mg cGMP psilocybin administered with manualized preparatory and integrative psychotherapy

Interventions

  • Psilocybin25 mg
    via Oral• single dose• 1 doses total

    25 mg cGMP psilocybin with manualized therapy; integrative therapy x4 post-dose.

Participants

Ages
21 – 99
Sexes
female

Inclusion Criteria

  • Inclusion Criteria:
  • 1. Aged ≥ 21 years
  • 2. Diagnosis of:
  • Early-stage breast cancer at low risk of recurrence (clinical stage 1 or 2; completed primary treatment [surgery, chemotherapy, and/or radiation] > 6 months ago; oncologist-reported 10-year risk < 20%)
  • Late-stage ovarian cancer at high risk of recurrence (clinical stage 3 or 4; currently in remission; oncologist-reported 10-year risk > 80%)
  • 3. Functional status: ECOG ≤ 1; Palliative Performance Scale (PPS) ≥ 60%
  • 4. Ability to tolerate oral medication
  • 5. Fear of recurrence at screening and baseline
  • 6. Have an identified support person and agree to be accompanied home (or to a safe destination) after dosing
  • 7. Participants of childbearing potential must agree to use effective birth control throughout the study.

Exclusion Criteria

  • Exclusion Criteria:
  • 1. Unstable medical conditions or serious abnormalities of CBC, chemistries, or ECG that in the opinion of the study physician would preclude safe participation (examples: congestive heart failure; valvular heart disease; clinically significant arrhythmias or ECG abnormality such as QTc > 450; recent acute myocardial infarction; 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: screening and baseline blood pressure > 140/90 mmHg
  • 3. Significant CNS pathology (e.g., primary or secondary cerebral neoplasm, epilepsy, history of stroke, cerebral aneurysm, dementia, delirium)
  • 4. Primary psychotic or affective psychotic disorders (e.g., schizophrenia spectrum, schizoaffective disorder, bipolar I/II with psychotic features, MDD with psychotic features, prior psychosis due to medical condition or substance)
  • 5. Family history of psychotic or serious bipolar spectrum illnesses (examples include first-degree relative with schizophrenia spectrum disorders, schizoaffective disorder, bipolar I with psychotic features)
  • 6. High risk of adverse emotional or behavioral reaction based on investigator judgement (e.g., agitation, violent behaviour)
  • 7. Active substance use disorders: DSM-5 moderate/severe alcohol or drug use disorder within past year; DAST-10 score ≥ 3; two or more positive CAGE responses
  • 8. Extensive use of serotonergic hallucinogens: any use in last 12 months or >25 lifetime uses
  • 9. Clinically significant suicidality or high risk of completed suicide (see suicidalityDetails)
  • 10. History of hallucinogen persisting perception disorder (HPPD)
  • 11. Pregnancy or lactation
  • 12. Cognitive impairment (MoCA < 23)
  • 13. Concurrent medications: antidepressants; centrally-acting serotonergic agents (e.g., MAO inhibitors); serotonin-acting dietary supplements (e.g., 5-HTP, St John's wort); antipsychotics; mood stabilizers (e.g., lithium, valproic acid); aldehyde dehydrogenase inhibitors (e.g., disulfiram); significant inhibitors of UGT1A10/UGT1A0; efavirenz
  • 14. Positive urine drug test for amphetamines, barbiturates, buprenorphine, benzodiazepines, cocaine, cannabis, methamphetamine, MDMA, methadone, opiates (unless prescribed), PCP
  • 15. Psychiatric condition incompatible with rapport with therapists or safe exposure to psilocybin
  • 16. Any psychological or physical symptom, medication, or other clinical finding making participant unsuitable per PI judgement
  • 17. Allergy or intolerance to materials in the drug product
  • 18. Non-English speaking individuals
  • 19. Enrolment in another clinical trial assessing interventions for anxiety, depression, or existential distress

Study Details

Locations

Outpatient CTRC — Aurora, Colorado, United States
University of Colorado Cancer Center — Aurora, Colorado, United States

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