Psilocybin-Assisted Therapy for the Treatment of Cancer-Related Anxiety in Patients With Metastatic Cancer

NCT05847686 | Completed Phase 1 Results DMC FDA Drug

• 3 other identifiers: RG1123316NCI-2023-02948FHIRB0020001
• Study Type: interventional
• Target: 55
• Locations: 1 country
• Sites: 1

Brief Summary

This phase I/II trial tests the safety and side effects of psilocybin in combination with therapy for the treatment of patients with metastatic cancer and symptoms of anxiety and/or depression. Psilocybin is a substance being studied in conjunction with therapy for the treatment of anxiety and depression in patients with cancer. In this study, the psilocybin being used is derived from the mushroom psilocybe cubensis using a patented process that results in a pharmaceutical grade version of psilocybin. Psilocybin acts by activating serotonin receptors on brain cells which can change perceptions and patterns of thinking in ways that may decrease anxiety.

Conditions

Hematopoietic and Lymphatic System Neoplasm; Metastatic Malignant Solid Neoplasm

Outcome Measures

Primary Outcomes (1)

• Number of Instances of Potentially Unattended Psilocybin-related Distress During Psilocybin Sessions.

  Defined as the occurrence of participant distress among study participants in the small group during the psilocybin administration session on Day 0 that requires 1:1 facilitator attention that cannot be met by the 4-person facilitation team. The size of small groups of different sizes will vary over the course of the study. Descriptive statistics will be used to analyze and will be tabulated on Day 0 after each group intervention. Backup facilitators will be available when this occurs.

  At psilocybin administration session on day 0

Secondary Outcomes (1)

• Change in Measured Anxiety and Depression: Hospital Anxiety and Depression Scale (HADS)

  From 14 days before the psilocybin session to 28 days (4 weeks) after the psilocybin session

Study Arms (1)

Treatment (psilocybin, therapy)

EXPERIMENTAL

Patients receive psilocybin PO and participate in group and individual therapy sessions on trial.

Other: Counseling; Drug: Psilocybin; Other: Questionnaire Administration

Interventions

Counseling OTHER

Participate in therapy visits

Also known as: Counseling Intervention

Treatment (psilocybin, therapy)

Psilocybin DRUG

Given PO

Also known as: CY-39, Indocybin, psilocybine

Treatment (psilocybin, therapy)

Questionnaire Administration OTHER

Ancillary studies

Treatment (psilocybin, therapy)

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• A diagnosis of metastatic solid tumor, or incurable hematologic malignancy that has been accepted by a physician in a medical record
• Measurable disease is not required
• Previous treatment with chemotherapy: There are no minimum or maximum prior lines of chemotherapy
• years of age
• Required performance status, including the appropriate scale. Eastern Cooperative Oncology Group (ECOG) 0-2
• Hematocrit \> 20
• Platelets (Plt) \> 20K
• Liver function tests 1.5 x normal
• Creatinine 1.5 x normal
• Subjects of childbearing potential must be willing to use an effective contraceptive method from study enrollment until at least 1 month after receiving the investigational agent(s)
• Must be at least 4 weeks after surgery or radiotherapy at study entry, but can be receiving oral or iv chemotherapy if those schedules can be adjusted around the medication session date
• Motivated to participate in a group study and able in the research team's judgment to participate in the small group effectively
• On pre-enrollment screening tests, they will have clinically significant anxiety or depressive symptoms as defined by a score of 11 or greater on the Hospital Anxiety and Depression Scale (HADS)-Total
• English speaking- able to understand the process of consent and the risk and benefits associated with the study, and able to give written informed consent. This is a pilot study, and if future larger studies are designed, consideration will be given for non-English-speaking subjects
• Must be willing to sign a medical release for the investigators to communicate directly with their treating clinicians (mental health professional or oncologist) and doctors to confirm a medication and/or medical history

You may not qualify if:

• Brain metastases that have not been treated
• Uncontrolled or concurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
• Pregnancy, breastfeeding, or expecting to conceive or father children for the duration of the trial through 30 days after receipt of investigational agent(s)
• Personal or immediate family history of schizophrenia, bipolar affective disorder, delusion disorder, paranoid disorder, or schizoaffective disorder
• Suicidal ideation with a Columbia-Suicidality Severity Rating Scale (C-SSRS) \>= 3
• Current substance abuse disorder (although prospective subjects will not be excluded for reasonable alcohol use that does not meet criteria for alcohol use disorder or marijuana use that does not meet criteria for substance use disorder)
• Neuroleptic (including olanzapine, prochlorperazine, promethazine), and selective serotonin reuptake inhibitor (SSRI) medications that cannot be tapered and discontinued in conjunction with the participant's prescribing physician (although ondansetron can be used for nausea)
• Unstable neurological or medical condition; history of seizure, chronic/severe headaches
• Use of tramadol, due to the potential for serotonin syndrome with concomitant use of psilocybin
• Individuals who are on MOAI (monoamine oxidase inhibitors) or who have a known sensitivity to the drug or its metabolites. Psilocybin is contraindicated in medications that are known UGT (UDP-glucuronosyltransferase) enzyme modulators. The concurrent use of SSRI/serotonin-norepinephrine reuptake inhibitor (SNRI) meds is assumed to be contraindicated due to the potential to increase the risk of serotonin syndrome and/or to attenuate the binding of psilocin to the HT2A receptor
• A marked baseline prolongation of QT/corrected QT (QTc) interval (e.g., demonstration on \> 1 electrocardiogram (ECG) of a QTc interval \> 450 milliseconds (ms)
• A history of additional risk factors for Torsade de Points (including but not limited to: heart failure, hypokalemia, family history of long QT syndrome)
• The use of concomitant medications that prolong the QT/QTc interval

Sponsors & Collaborators

• University of Washington: lead
• Steven & Alexandra Cohen Foundation: collaborator

Study Sites (1)

Fred Hutch/University of Washington Cancer Consortium

Seattle, Washington, 98109, United States

Location

Related Publications (1)

• Back A, Myers S, Guy J, Perez J, Lazar Thorn L, McGregor B. Evolving Guidelines for the Use of Touch During a Clinical Trial of Group Psilocybin-Assisted Therapy. Psychedelic Med (New Rochelle). 2024 Dec 2;2(4):187-191. doi: 10.1089/psymed.2023.0069. eCollection 2024 Dec.

  PMID: 40051480 DERIVED

MeSH Terms

Conditions

Neoplasm Metastasis

Interventions

Counseling; Psilocybin

Condition Hierarchy (Ancestors)

Neoplastic Processes; Neoplasms; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Mental Health Services; Behavioral Disciplines and Activities; Community Health Services; Health Services; Health Care Facilities Workforce and Services; Indole Alkaloids; Alkaloids; Heterocyclic Compounds; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Tryptamines; Indolizidines; Indolizines

Limitations and Caveats

This is a single arm open label Phase 1-2 study.

Results Point of Contact

• Title: Anthony Back MD
• Organization: University of Washington

tonyback@uw.edu

2066194367

Study Officials

• Anthony Back

  Fred Hutch/University of Washington Cancer Consortium

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: April 26, 2023
• First Posted: May 8, 2023
• Study Start: June 27, 2023
• Primary Completion: April 8, 2024
• Study Completion: October 17, 2024
• Last Updated: November 5, 2025
• Results First Posted: April 30, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)