Study of Psilocybin Assisted Psychotherapy to Address Fear of Recurrence

NCT06430541 | Recruiting Phase 1 DMC FDA Drug

• 2 other identifiers: 23-1455.ccNCI-2024-04762
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 2

Brief Summary

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

Breast Cancer; Ovarian Cancer

Outcome Measures

Primary Outcomes (1)

• Change in Fear of Cancer Recurrence Inventory

  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.

  1-week, 4-weeks, 8-weeks* (primary outcome time point), 12-weeks, and 24-weeks.

Secondary Outcomes (1)

• Safety as measured by adverse events

  for the duration of study participation -6 months

Other Outcomes (5)

• Depression

  Baseline, 1-week, 4-weeks, 8-weeks, 12-weeks, and 24-weeks

• Anxiety

  Baseline, 1-week, 4-weeks, 8-weeks, 12-weeks, and 24-weeks

• Cancer-related Existential Distress

  Baseline, 1-week, 4-weeks, 8-weeks, 12-weeks, and 24-weeks

Study Arms (1)

Psilocybin Assisted Psychotherapy

EXPERIMENTAL

25mg cGMP Psilocybin in combination with manualized therapy

Drug: Psilocybin

Interventions

Psilocybin DRUG

A tryptamine that produces its behavioral effects primarily by acting as post-synaptic agonists at serotonin 5-HT2A and 5-HT2c receptors.

Psilocybin Assisted Psychotherapy

Eligibility Criteria

• Age: 21 Years+
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• , 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

Sponsors & Collaborators

• University of Colorado, Denver: lead
• Usona Institute: collaborator

Study Sites (2)

Outpatient CTRC

Aurora, Colorado, 80045, United States

RECRUITING

University of Colorado Cancer Center

Aurora, Colorado, 80045, United States

RECRUITING

MeSH Terms

Conditions

Breast Neoplasms; Ovarian Neoplasms

Interventions

Psilocybin

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Endocrine Gland Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Neoplasms, Female; Urogenital Neoplasms; Genital Diseases; Endocrine System Diseases; Gonadal Disorders

Intervention Hierarchy (Ancestors)

Indole Alkaloids; Alkaloids; Heterocyclic Compounds; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Tryptamines; Indolizidines; Indolizines

Study Officials

• Stacy Fischer, MD

  University of Colorado, Denver

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mary Mancuso

CONTACT

303-724-5729; mary.mancuso@cuanschutz.edu

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 21, 2024
• First Posted: May 28, 2024
• Study Start: November 21, 2024
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2028
• Last Updated: April 21, 2026

Record last verified: 2025-07

Locations

US (2)