Psilocybin-assisted Existential, Attachment and RelationaL (PEARL) Therapy for Caregivers of Patients With Advanced Cancer (PEARL-C1)

This Phase II open-label trial (n=15) will study the effects of psilocybin (25mg) administered in the context of Psilocybin-assisted Existential, Attachment and Relational (PEARL) therapy for caregivers of patients with advanced cancer.

Conducted by the University Health Network in Toronto, this trial seeks to assess the feasibility, acceptability, and safety of PEARL therapy—a novel therapeutic approach that combines high-dose psilocybin with psychotherapeutic techniques tailored to the complex emotional needs of caregivers. Participants will engage in a structured process that includes preparatory therapy sessions, a monitored psilocybin dosing session, and post-dose integration therapy. The aim is to address symptoms such as depression, anxiety, anticipatory grief, and spiritual suffering, which are often experienced by caregivers of individuals with advanced cancer but for which few effective, evidence-based treatments currently exist.

The study also intends to contribute to the development of clinical and policy guidelines for psychedelic-assisted therapies in palliative contexts. Eligible participants must be adult caregivers in Ontario with at least mild anxiety or depression, and affiliated with patients receiving psilocybin through a related study or the Special Access Program. By incorporating both psychological support and psychedelic intervention, this trial hopes to refine an integrated model of care that can alleviate caregiver distress and enhance quality of life.

Topic Palliative Care Healthy Subjects Depression Anxiety Relationships
Compound Psilocybin
Country Canada
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University Health Network Toronto
University Health Network is a public research and teaching hospital network in Toronto. The Nikean Psychedelic Psychotherapy Research Centre was established in 2021.

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