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

Breast Cancer Clinical Trial

Official title:

A Phase 1b Study of Psilocybin Assisted Psychotherapy to Address Fear of Recurrence in Patients Diagnosed With Early-stage Breast Cancer and Ovarian Cancer in Remission

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06430541
• Other study ID #: 23-1455.cc
• Status: Not yet recruiting
• Phase: Phase 1
• Start date: December 2024
• Est. completion date: December 2028

Study information

• Verified date: May 2024
• Source: University of Colorado, Denver
• Contact: Mary Mancuso
• Phone: 303-724-5729
• Email: mary.mancuso[@]cusanschutz.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 20
• Est. completion date: December 2028
• Est. primary completion date: December 2026
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 21 Years and older

Eligibility

Inclusion Criteria:

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.

Exclusion Criteria:

1. 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

2. Risk for hypertensive crisis defined as:

Screening, Baseline, Medication session (predose) blood pressure >140/90 mmHg

3. Significant central nervous system (CNS) pathology

Examples include:

• 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.

Examples include first-degree relative with:

• 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:

• Montreal Cognitive Assessment Test (MoCA) < 23

13. Concurrent Medications

• 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 1A10
• Efavirenz

14. Have a positive urine drug test including Amphetamines, Barbiturates, Buprenorphine, Benzodiazepines, Cocaine, Cannabis, Methamphetamine, MDMA, Methadone, Opiates (Morphine, Oxycodone), 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)

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms
• Carcinoma, Ovarian Epithelial
• Ovarian Cancer
• Ovarian Neoplasms
• Recurrence

Intervention

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

Locations

Country	Name	City	State
United States	Outpatient CTRC	Aurora	Colorado
United States	University of Colorado Cancer Center	Aurora	Colorado

Sponsors (2)

Lead Sponsor	Collaborator
University of Colorado, Denver	Usona Institute

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Depression	Symptoms of depression as measured by HADS-D	Baseline, 1-week, 4-weeks, 8-weeks, 12-weeks, and 24-weeks
Other	Anxiety	Symptoms of anxiety as measured by HADS-A	Baseline, 1-week, 4-weeks, 8-weeks, 12-weeks, and 24-weeks
Other	Cancer-related Existential Distress	Demoralization Syndrome will be measured with the Demoralization Scale Version II (DS-II)	Baseline, 1-week, 4-weeks, 8-weeks, 12-weeks, and 24-weeks
Other	Quality of Life-FACT-G	Quality of life as measured by FACT-G	Baseline, 1-week, 4-weeks, 8-weeks, 12-weeks, and 24-weeks
Other	Spirituality	Spirituality as measured by FACT-Sp	Baseline, 1-week, 4-weeks, 8-weeks, 12-weeks, and 24-weeks
Primary	Change in Fear of Cancer Recurrence Inventory	Measured by change in core on the Fear of Recurrence Inventory completed at screening and baseline.	1-week, 4-weeks, 8-weeks* (primary outcome time point), 12-weeks, and 24-weeks.
Secondary	Safety as measured by adverse events	Assess Adverse Events, Treatment Emergent Adverse Events, Serious Adverse Events	for the duration of study participation -6 months