PSilocybin for psYCHological and Existential Distress in PALliative care (PSYCHED-PAL): A multi-site, open-label, single arm phase I/II proof-of-concept, dose-finding, and feasibility clinical trial

Existential (psychological) distress causes suffering at the end of life and existing treatments don’t work well and are challenging to use. Studies have shown taking large doses of psilocybin (“magic mushrooms”) can reduce psychological distress in palliative care patients with cancer, but this is burdensome for patients and resource intensive. However, psilocybin microdosing (taking very small daily doses that don’t cause hallucinations) may be a more acceptable option and work similarly well.
This study will evaluate the safety, feasibility, and preliminary efficacy of psilocybin microdosing for treating existential distress in 20 palliative care patients. Participants will receive increasing microdoses of psilocybin over four weeks. We will determine the dose at which patients’ distress improves, monitor safety, and see if any benefits of psilocybin microdosing last long-term.
If effective, psilocybin microdosing could improve the lives of the 30% of patients who experience psychological suffering at the end of life.