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

This Phase II open-label trial (n=15) will study Psilocybin-assisted Existential, Attachment and Relational (PEARL; 25mg) therapy for patients with advanced cancer.

Participants will receive a single high-dose (25 mg) of psilocybin within the context of PEARL therapy.

Conducted by the University Health Network in Toronto, this trial aims to evaluate the feasibility, acceptability, and safety of PEARL therapy. PEARL therapy integrates elements from psilocybin-assisted psychotherapy with individual psychotherapies designed for advanced cancer patients.

The study seeks to reduce psychological and existential distress among participants, contributing to research on the efficacy of psychedelic-assisted therapies.

The outcomes will guide future clinical practices and policy. The trial is expected to run from June 2024 to June 2026.

Topic Palliative Care
Compound Psilocybin
Country Canada
Visit trial
Status Not yet recruiting
Results Published No
Start date 01 June 2024
End date 15 June 2026
Phase Phase II
Design Open
Type Interventional
Generation First
Participants 14
Sex All
Age 18- 99
Therapy Yes

Trial Details

Individuals with advanced cancer often suffer from significant distress due to physical pain, difficult treatment choices, social isolation, and fear of death. While many treatments address physical symptoms, fewer standard approaches exist for psychological suffering. Recent research supports psychotherapies that incorporate existential, attachment, and relational methods, as well as psilocybin-assisted psychotherapy, which reduces end-of-life distress. Combining these approaches, PEARL therapy (Psilocybin-assisted Existential, Attachment, and Relational therapy) includes preparatory sessions, a high-dose drug session, and integration sessions. This study will assess the feasibility, acceptability, and safety of PEARL therapy for advanced cancer patients, potentially improving quality of life and guiding future clinical practices.

NCT Number NCT06416085

Sponsors & Collaborators

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.

Data attribution

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