A Second Psilocybin Group Therapy for the Treatment of Cancer-Related Anxiety in Partial Responders With Metastatic Cancer

NCT06644170 | Completed Phase 1 FDA Drug

• 3 other identifiers: RG1124860NCI-2024-0805820619
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief Summary

This phase I trial tests the safety and side effects of a second episode of psilocybin-assisted group therapy and how well it works in treating anxiety and distress in patients with cancer that has spread from where it first started (primary site) to other places in the body (metastatic) and had a partial response to their first retreat. Up to 50% of patients with metastatic cancer have clinically significant anxiety and unaddressed anxiety and distress may add to the suffering caused by cancer itself. Psilocybin, a psychedelic drug, is made using an extract from the psilocybe mushroom, also known as "magic mushrooms". Psilocybin binds to serotonin receptors (natural body chemicals that control moods) on brain cells producing intense changes in mood, including anxiety. This may change perceptions and patterns of thinking in ways that may decrease anxiety. Group therapy may reduce stress and improve the well-being and quality of life of patients with metastatic cancer. A second episode of psilocybin-assisted group therapy may be safe, tolerable and or effective in treating anxiety and distress in partial responders with metastatic cancer.

Conditions

Hematopoietic and Lymphatic System Neoplasm; Metastatic Malignant Solid Neoplasm

Outcome Measures

Primary Outcomes (1)

• Incidence of adverse events (AEs)

  AEs will be defined as any untoward medical occurrence in a clinical investigation subject administered a medicinal product. AEs will be graded in severity using mild, moderate and severe. Occurrence of any adverse event graded severe on the Common Terminology Criteria for Adverse Events patient-reported questionnaires. Descriptive statistics will be used to analyze all adverse events, and in particular severe adverse events.

  At time of first exposure up to the date of the last questionnaire at 24 weeks

Secondary Outcomes (1)

• Change in anxiety and depression

  At day -14 up to day 28

Study Arms (1)

Treatment (psilocybin, group therapy)

EXPERIMENTAL

Patients receive psilocybin PO with optional booster dose on day 0. Patients attend an individual prep visit on day -1 and an individual integration visit on day 1. Patients also attend group preparation visits on days -14, -7 and -1 and group integration visits on days 1, 8, 22 and 36.

Behavioral: Behavioral Intervention; Behavioral: Group Therapy; Drug: Psilocybin; Other: Questionnaire Administration

Interventions

Behavioral Intervention BEHAVIORAL

Attend individual visits

Also known as: Psychedelic therapy

Treatment (psilocybin, group therapy)

Group Therapy BEHAVIORAL

Attend group visits

Treatment (psilocybin, group therapy)

Psilocybin DRUG

Given PO

Treatment (psilocybin, group therapy)

Questionnaire Administration OTHER

Ancillary studies

Treatment (psilocybin, group 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:

• Participation in BACK002, with outcome measures that showed: a low Mystical Experience Questionnaire (MEQ) score, OR a small (or negative) Hospital Anxiety and Depression Scale (HADS) change score, OR a last HADS score that was 11 or greater, OR who have experienced a recurrence in their symptoms of anxiety or depression since completing the 6 month follow-up
• 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 intravenous (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 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

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)
• 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 MAOI (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
• Baseline prolongation of QT/corrected QT (QTc) interval (e.g., demonstration on an eligibility 12-lead 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
• Any history of cardiovascular disease such as history of myocardial infarction or congestive heart failure or cardiac arrhythmia
• Concomitant use of efavirenz (an antiviral) which cannot be tapered
• Concomitant use of serotonin-acting supplements due to their potential for interaction with psilocybin, including oxitriptan (5-HTP), St John's Wort, and 'brain food' supplements

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

MeSH Terms

Conditions

Neoplasm Metastasis

Interventions

Behavior Therapy; Psychotherapy, Group; Psilocybin

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Psychotherapy; Behavioral Disciplines and Activities; Socioenvironmental Therapy; Indole Alkaloids; Alkaloids; Heterocyclic Compounds; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Tryptamines; Indolizidines; Indolizines

Study Officials

• Anthony L. Back, MD

  Fred Hutch/University of Washington Cancer Consortium

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: October 11, 2024
• First Posted: October 16, 2024
• Study Start: November 19, 2024
• Primary Completion: September 30, 2025
• Study Completion: September 30, 2025
• Last Updated: October 14, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)