OncoMatch/Clinical Trials/NCT07336238
Group Retreat Psilocybin Therapy for the Treatment of Anxiety and Depression in Patients With Metastatic Solid Tumors or Incurable Hematologic Malignancies
Is NCT07336238 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies Psilocybin for anxiety.
Treatment: Psilocybin — 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.
Check if I qualifyExtracted eligibility criteria
Cancer type
Tumor Agnostic
Disease stage
Metastatic disease required
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Lab requirements
Blood counts
Hematocrit > 20; Platelets (plt) > 20K
Kidney function
Creatinine 1.5 x normal
Liver function
Liver function tests 1.5 x normal
Cardiac function
Baseline prolongation of QT/corrected QT (QTc) interval (QTc > 450 ms); history of additional risk factors for Torsade de Points; any history of cardiovascular disease such as history of myocardial infarction or congestive heart failure or cardiac arrhythmia
Hematocrit > 20; Platelets (plt) > 20K; Liver function tests 1.5 x normal; Creatinine 1.5 x normal; Baseline prolongation of QT/corrected QT (QTc) interval (QTc > 450 ms); history of additional risk factors for Torsade de Points; any history of cardiovascular disease such as history of myocardial infarction or congestive heart failure or cardiac arrhythmia
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- Fred Hutch/University of Washington Cancer Consortium · Seattle, Washington
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