## Protocol Section
### Identification Module
**NCT ID:** NCT06430541

**Brief Title:** A Phase 1b Study of Psilocybin Assisted Psychotherapy to Address Fear of Recurrence

**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

#### Organization Study ID Info
**ID:** 23-1455.cc
#### Organization
**Class:** OTHER
**Full Name:** University of Colorado, Denver
### Status Module
#### Completion Date
**Date:** 2028-12

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-28

**Type:** ACTUAL

**Last Update Submit Date:** 2024-05-21

**Overall Status:** NOT_YET_RECRUITING

#### Primary Completion Date
**Date:** 2026-12

**Type:** ESTIMATED

#### Start Date
**Date:** 2024-12

**Type:** ESTIMATED

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-28
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-21
**Study First Submit QC Date:** 2024-05-21
### Sponsor Collaborators Module

#### Collaborators

**Class:** OTHER

**Name:** Usona Institute

#### Lead Sponsor

**Class:** OTHER

**Name:** University of Colorado, Denver

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** True

**Oversight Has DMC:** True

### Description Module

**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 Module

**Conditions:**

- Breast Cancer

- Ovarian Cancer

### Design Module

#### Design Info

**Allocation:** NA

**Intervention Model:** SINGLE_GROUP

##### Masking Info

**Masking:** NONE

**Primary Purpose:** SUPPORTIVE_CARE

#### Enrollment Info

**Count:** 20

**Type:** ESTIMATED

**Phases:**

- PHASE1

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** 25mg cGMP Psilocybin in combination with manualized therapy

**Intervention Names:**

- Drug: Psilocybin

**Label:** Psilocybin Assisted Psychotherapy

**Type:** EXPERIMENTAL

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Psilocybin Assisted Psychotherapy

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

**Name:** Psilocybin

**Type:** DRUG

### Outcomes Module

#### Other Outcomes

**Description:** Symptoms of depression as measured by HADS-D

**Measure:** Depression

**Time Frame:** Baseline, 1-week, 4-weeks, 8-weeks, 12-weeks, and 24-weeks

**Description:** Symptoms of anxiety as measured by HADS-A

**Measure:** Anxiety

**Time Frame:** Baseline, 1-week, 4-weeks, 8-weeks, 12-weeks, and 24-weeks

**Description:** Demoralization Syndrome will be measured with the Demoralization Scale Version II (DS-II)

**Measure:** Cancer-related Existential Distress

**Time Frame:** Baseline, 1-week, 4-weeks, 8-weeks, 12-weeks, and 24-weeks

**Description:** Quality of life as measured by FACT-G

**Measure:** Quality of Life-FACT-G

**Time Frame:** Baseline, 1-week, 4-weeks, 8-weeks, 12-weeks, and 24-weeks

**Description:** Spirituality as measured by FACT-Sp

**Measure:** Spirituality

**Time Frame:** Baseline, 1-week, 4-weeks, 8-weeks, 12-weeks, and 24-weeks

#### Primary Outcomes

**Description:** Measured by change in core on the Fear of Recurrence Inventory completed at screening and baseline.

**Measure:** Change in Fear of Cancer Recurrence Inventory

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

#### Secondary Outcomes

**Description:** Assess Adverse Events, Treatment Emergent Adverse Events, Serious Adverse Events

**Measure:** Safety as measured by adverse events

**Time Frame:** for the duration of study participation -6 months

### Eligibility Module

**Eligibility Criteria:** 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)

**Gender Based:** True

**Minimum Age:** 21 Years

**Sex:** FEMALE

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** mary.mancuso@cusanschutz.edu

**Name:** Mary Mancuso

**Phone:** 303-724-5729

**Role:** CONTACT

#### Locations

**Location 1:**

**City:** Aurora

**Contacts:**

***Contact 1:***

- **Name:** Stacy Fischer, MD

- **Role:** PRINCIPAL_INVESTIGATOR

**Country:** United States

**Facility:** Outpatient CTRC

**State:** Colorado

**Zip:** 80045

**Location 2:**

**City:** Aurora

**Contacts:**

***Contact 1:***

- **Email:** stacy.fischer@cuanschutz.edu

- **Name:** Stacy Fischer, MD

- **Phone:** 303-724-6353

- **Role:** CONTACT

***Contact 2:***

- **Name:** Stacy Fischer, MD

- **Role:** PRINCIPAL_INVESTIGATOR

**Country:** United States

**Facility:** University of Colorado Cancer Center

**State:** Colorado

**Zip:** 80045

#### Overall Officials

**Official 1:**

**Affiliation:** University of Colorado, Denver

**Name:** Stacy Fischer, MD

**Role:** PRINCIPAL_INVESTIGATOR

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000009371

- Term: Neoplasms by Site

- ID: D000009369

- Term: Neoplasms

- ID: D000001941

- Term: Breast Diseases

- ID: D000012871

- Term: Skin Diseases

- ID: D000004701

- Term: Endocrine Gland Neoplasms

- ID: D000010049

- Term: Ovarian Diseases

- ID: D000000291

- Term: Adnexal Diseases

- ID: D000005831

- Term: Genital Diseases, Female

- ID: D000052776

- Term: Female Urogenital Diseases

- ID: D000005261

- Term: Female Urogenital Diseases and Pregnancy Complications

- ID: D000091642

- Term: Urogenital Diseases

- ID: D000005833

- Term: Genital Neoplasms, Female

- ID: D000014565

- Term: Urogenital Neoplasms

- ID: D000091662

- Term: Genital Diseases

- ID: D000004700

- Term: Endocrine System Diseases

- ID: D000006058

- Term: Gonadal Disorders

- ID: D000002277

- Term: Carcinoma

- ID: D000009375

- Term: Neoplasms, Glandular and Epithelial

- ID: D000009370

- Term: Neoplasms by Histologic Type

- ID: D000020969

- Term: Disease Attributes

- ID: D000010335

- Term: Pathologic Processes

### Condition Browse Module - Browse Branches

- Abbrev: BC04

- Name: Neoplasms

- Abbrev: BC17

- Name: Skin and Connective Tissue Diseases

- Abbrev: All

- Name: All Conditions

- Abbrev: BXS

- Name: Urinary Tract, Sexual Organs, and Pregnancy Conditions

- Abbrev: BC19

- Name: Gland and Hormone Related Diseases

- Abbrev: BC23

- Name: Symptoms and General Pathology

- Abbrev: Rare

- Name: Rare Diseases

### Condition Browse Module - Browse Leaves

- ID: M5220

- Name: Breast Neoplasms

- Relevance: HIGH

- As Found: Breast Cancer

- ID: M12974

- Name: Ovarian Neoplasms

- Relevance: HIGH

- As Found: Ovarian Cancer

- ID: M1704

- Name: Carcinoma, Ovarian Epithelial

- Relevance: HIGH

- As Found: Ovarian Cancer

- ID: M14850

- Name: Recurrence

- Relevance: HIGH

- As Found: Recurrence

- ID: M5534

- Name: Carcinoma

- Relevance: LOW

- As Found: Unknown

- ID: M5218

- Name: Breast Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M15674

- Name: Skin Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M7863

- Name: Endocrine Gland Neoplasms

- Relevance: LOW

- As Found: Unknown

- ID: M12972

- Name: Ovarian Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M3643

- Name: Adnexal Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M8943

- Name: Genital Diseases, Female

- Relevance: LOW

- As Found: Unknown

- ID: M2876

- Name: Genital Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M2875

- Name: Urogenital Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M27093

- Name: Female Urogenital Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M14127

- Name: Pregnancy Complications

- Relevance: LOW

- As Found: Unknown

- ID: M8399

- Name: Female Urogenital Diseases and Pregnancy Complications

- Relevance: LOW

- As Found: Unknown

- ID: M8945

- Name: Genital Neoplasms, Female

- Relevance: LOW

- As Found: Unknown

- ID: M17315

- Name: Urogenital Neoplasms

- Relevance: LOW

- As Found: Unknown

- ID: M7862

- Name: Endocrine System Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M9163

- Name: Gonadal Disorders

- Relevance: LOW

- As Found: Unknown

- ID: M12320

- Name: Neoplasms, Glandular and Epithelial

- Relevance: LOW

- As Found: Unknown

- ID: M12315

- Name: Neoplasms by Histologic Type

- Relevance: LOW

- As Found: Unknown

- ID: M22700

- Name: Disease Attributes

- Relevance: LOW

- As Found: Unknown

- ID: T4352

- Name: Ovarian Cancer

- Relevance: HIGH

- As Found: Ovarian Cancer

- ID: T4354

- Name: Ovarian Epithelial Cancer

- Relevance: HIGH

- As Found: Ovarian Cancer

### Condition Browse Module - Meshes

- ID: D000001943

- Term: Breast Neoplasms

- ID: D000010051

- Term: Ovarian Neoplasms

- ID: D000077216

- Term: Carcinoma, Ovarian Epithelial

- ID: D000012008

- Term: Recurrence

### Intervention Browse Module - Ancestors

- ID: D000006213

- Term: Hallucinogens

- ID: D000045505

- Term: Physiological Effects of Drugs

- ID: D000011619

- Term: Psychotropic Drugs

### Intervention Browse Module - Browse Branches

- Abbrev: PsychDr

- Name: Psychotropic Drugs

- Abbrev: All

- Name: All Drugs and Chemicals

### Intervention Browse Module - Browse Leaves

- ID: M14419

- Name: Psilocybin

- Relevance: HIGH

- As Found: Cover

- ID: M15512

- Name: Serotonin

- Relevance: LOW

- As Found: Unknown

- ID: M9305

- Name: Hallucinogens

- Relevance: LOW

- As Found: Unknown

- ID: M14474

- Name: Psychotropic Drugs

- Relevance: LOW

- As Found: Unknown

### Intervention Browse Module - Meshes

- ID: D000011562

- Term: Psilocybin

### Misc Info Module

- Version Holder: 2024-05-31
