Psilocybin Microdose for Psychological and Existential Distress in Palliative Care (PSYCHED-PAL-RCT)

This Phase III, double-blind, placebo-controlled, parallel-arm trial (n=120) will study the effects of psilocybin microdosing (2–3mg, 4 days per week for 2 weeks) on psychological and existential distress in patients receiving palliative care for advanced illness.

Led by the Bruyère Health Research Institute and conducted across seven sites in Canada, this study aims to assess whether small, non-hallucinogenic doses of psilocybin can safely and effectively reduce depression, anxiety, and feelings of hopelessness in people with limited life expectancy.

Participants will be randomly assigned to receive either psilocybin or placebo, dosed according to body weight (<55 kg: 2mg; ≥55 kg: 3mg), taken on four non-consecutive days per week (Monday, Tuesday, Thursday, Friday) for two weeks. After the two-week intervention and follow-up, all participants will be offered open-label psilocybin treatment, with an optional extension phase allowing for continued microdosing in three-week cycles for up to one year.

This trial builds on earlier Phase II work by the same research group, which showed that psilocybin microdosing improved psychological distress in patients with advanced illness with minimal side effects. The current study seeks to provide more rigorous, placebo-controlled evidence. Researchers hope this low-dose, scalable, and non-hallucinogenic treatment model will offer a viable therapeutic option in palliative care settings, where time, tolerance, and access to psychotherapy can be limiting factors.

Topic Palliative Care Depression Adolescence and Psychedelics Microdosing
Compound Psilocybin Placebo
Country Canada
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Trial Details



Trial Number

Sponsors & Collaborators

Bruyere Research Institute
The Bruyere Research Institutewill serve as a test site in an upcoming trial with psilocybin.

Data attribution

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