Actively Recruiting
Group Retreat Psilocybin Therapy for the Treatment of Anxiety and Depression in Patients With Metastatic Solid Tumors or Incurable Hematologic Malignancies
Led by University of Washington · Updated on 2026-04-17
18
Participants Needed
1
Research Sites
85 weeks
Total Duration
On this page
Sponsors
U
University of Washington
Lead Sponsor
H
Healing Hearts, Changing Minds, Inc.
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
Group Retreat Psilocybin Therapy for the Treatment of Anxiety and Depression in Patients With Metastatic Solid Tumors or Incurable Hematologic Malignancies
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosis of metastatic solid tumor or incurable hematologic malignancy confirmed by a physician
- Age between 18 and 85 years
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2
- Hematocrit greater than 20
- Platelets greater than 20,000
- Liver function tests up to 1.5 times normal
- Creatinine up to 1.5 times normal
- Use of effective contraception from enrollment until at least 1 month after treatment for those of childbearing potential
- At least 4 weeks since surgery or radiotherapy before study entry
- Ability to adjust chemotherapy schedule around medication session if receiving chemotherapy
- Motivation and ability to participate effectively in small group therapy
- Clinically significant anxiety or depressive symptoms with a HADS-Anxiety score of 11 or greater
- English speaking and able to provide informed consent
- Willingness to sign medical release for communication with treating clinicians
- Availability of an adult contact who can monitor behavior daily and notify research staff of changes
- Review of antidepressant use
- No starting new psychiatric medications during the study; limited use of certain psychiatric medications permitted with review
- Contact available for emergency if participant becomes suicidal
- Negative pregnancy test at baseline and prior to medication dosing for those of childbearing potential
- Willingness to commit to all therapy sessions, medication dosing, evaluations, and follow-up contacts
You will not qualify if you...
- Untreated brain metastases
- Uncontrolled or concurrent illnesses that would limit study compliance, including active infections, symptomatic heart failure, unstable angina, arrhythmia, or psychiatric/social issues
- Pregnancy, breastfeeding, or plans to conceive or father children during study and 30 days after treatment
- Personal or immediate family history of schizophrenia, bipolar disorder, delusion disorder, paranoid disorder, or schizoaffective disorder
- Suicidal ideation assessed as low or no risk
- Current substance abuse disorder, excluding reasonable alcohol or marijuana use
- Unstable neurological or medical conditions, history of seizures or severe headaches
- Use of high doses of psychedelic drugs within prior 3 months; microdosing allowed with discontinuation 1 month before study
- Use of tramadol
- Use of monoamine oxidase inhibitors or sensitivity to the study drug or its metabolites
- Prolonged QTc interval (> 450 ms) on ECG
- Additional risk factors for Torsade de Pointes
- Use of medications that prolong QT/QTc interval
- History of cardiovascular disease such as myocardial infarction, heart failure, or arrhythmia
- Use of efavirenz that cannot be tapered
- Use of serotonin-acting supplements like 5-HTP, St John's Wort, or brain food supplements due to interaction potential
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Fred Hutch/University of Washington Cancer Consortium
Seattle, Washington, United States, 98109
Actively Recruiting
Research Team
A
Anthony Back, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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