Psilocybin Therapy for Anxiety and Depression in Cancer
What You Need to Know Before You Apply
What is the purpose of this trial?
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.
Who Is on the Research Team?
Anthony Back, MD
Principal Investigator
Fred Hutch/University of Washington Cancer Consortium
Are You a Good Fit for This Trial?
This trial is for patients with metastatic solid tumors or incurable blood cancers who are experiencing anxiety and depression. Participants must be adults capable of giving consent and able to engage in therapy sessions. Those with certain psychiatric disorders, heart conditions, or on medications that interact poorly with psilocybin cannot join.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Preparation
Participants attend group and individual preparation therapy sessions
Treatment
Participants receive psilocybin therapy, with potential for a booster dose
Integration
Participants attend group and individual integration therapy sessions
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Psilocybin
Trial Overview
The study examines the safety and effectiveness of group retreat psilocybin therapy combined with psychotherapy for reducing anxiety and depression in cancer patients. It involves taking a pharmaceutical-grade psilocybin approved for research, followed by structured discussions.
How Is the Trial Designed?
1
Treatment groups
Experimental Treatment
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).
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of Washington
Lead Sponsor
Healing Hearts, Changing Minds, Inc.
Collaborator
Psilo Scientific Ltd
Collaborator
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