Group Retreat Psilocybin Therapy for the Treatment of Anxiety and Depression in Patients With Metastatic Solid Tumors or Incurable Hematologic Malignancies

NCT07336238 | Recruiting Phase 2 DMC FDA Drug

• 3 other identifiers: RG1126153NCI-2025-09712FHIRB0021135
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

Brief Summary

This phase II trial tests the safety, side effects and how well group retreat psilocybin therapy works for the treatment of anxiety and depression in patients with solid tumors that have spread from where they first started (primary site) to other places in the body (metastatic) or with hematologic cancers for which no treatment is currently available (incurable). For patients with metastatic, incurable cancer, unrelieved anxiety and existential distress can cause profound suffering. Psilocybin therapy can relieve anxiety and existential distress by disrupting patterns of thinking that contribute to anxiety and depression. Psilocybin is a substance being studied in the treatment of anxiety or depression in patients with cancer. In this study, a pharmaceutical grade of psilocybin will be used that has been approved by the FDA for research, provided by Filament Health. Psilocybin acts on the brain by resetting the brain's activity and increasing connections between brain regions, particularly those involved in mood regulation and self-perception. In this study psilocybin is combined with structured discussions and reflections that enable patients to have new insights about their situation. In a prior study, group retreat psilocybin therapy was proven to be safe and this study tests a refined dosing regimen for symptoms of anxiety and depression in patients with metastatic solid tumors or incurable hematologic malignancies.

Conditions

Anxiety; Depression; Hematopoietic and Lymphatic System Neoplasm; Metastatic Malignant Solid Neoplasm

Outcome Measures

Primary Outcomes (1)

• Incidence of adverse events

  Occurrence of any adverse event graded Severe on the Common Terminology Criteria for Adverse Events (CTCAE).

  Up to 6 months

Secondary Outcomes (1)

• Symptoms of Anxiety and Depression assessed via the Hospital Anxiety and Depression Scale (HADS): Change in Mean Total score

  At day -14, 2 weeks, 1 month, 2 months, 3 months, 6 months

Study Arms (1)

Treatment (psilocybin therapy)

EXPERIMENTAL

Patients attend group preparation therapy sessions on days -14 (virtual), -7 (virtual) and -1 (in person), and also attend an individual preparation therapy session on day -1 (in person). Patients receive psilocybin orally (PO) on day 0. Patients may receive an additional "booster" dose 60-90 minutes after the initial dose based on the physician's clinical judgement. Patients attend group integration therapy sessions on days 1 (in person), 8 (virtual), 15 (virtual), and 22 (virtual), and attend individual integration therapy sessions on days 1 (in person) and 8 (virtual).

Behavioral: Psychotherapy; Drug: Psilocybin; Other: Survey Administration

Interventions

Psychotherapy BEHAVIORAL

Attend therapy sessions

Also known as: therapy, talk therapy

Treatment (psilocybin therapy)

Psilocybin DRUG

Given PO

Also known as: psilocybine

Treatment (psilocybin therapy)

Survey 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 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 Hospital and Anxiety Depression Scale-Anxiety (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 phase 2a 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-Suicide Severity Rating Scale (C-SSRS) measurement of 'low risk' or no risk
• 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 UDP-glucuronosyltransferase (UGT) enzyme modulators
• Baseline prolongation of QT/corrected QT (QTc) interval (e.g., demonstration on a 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 5-HTP, St John's Wort, and 'brain food' supplements

Sponsors & Collaborators

• Psilo Scientific Ltd: collaborator
• Healing Hearts, Changing Minds, Inc.: collaborator
• University of Washington: lead

Study Sites (1)

Fred Hutch/University of Washington Cancer Consortium

Seattle, Washington, 98109, United States

RECRUITING

MeSH Terms

Conditions

Anxiety Disorders; Depression; Neoplasm Metastasis

Interventions

Psychotherapy; Therapeutics; Psilocybin

Condition Hierarchy (Ancestors)

Mental Disorders; Behavioral Symptoms; Behavior; Neoplastic Processes; Neoplasms; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

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

Study Officials

• Anthony Back, MD

  Fred Hutch/University of Washington Cancer Consortium

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Anthony Back, MD

CONTACT

206-619-4367; tonyback@uw.edu

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 9, 2026
• First Posted: January 13, 2026
• Study Start: May 19, 2026
• Primary Completion (Estimated): July 1, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: May 29, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)