Clinical TrialPalliative & End-of-Life DistressPsilocybinRecruiting

Psilocybin for Psychological and Existential Distress in Palliative Care

Multi-centre Phase I/II open-label, single-arm feasibility study (n=20) of psilocybin microdosing (1–3 mg/day, Mon–Fri for up to 4 weeks) to treat psychological distress in patients with advanced illness under palliative care.

Target Enrollment
20 participants
Study Type
Phase I/II interventional
Design
Non-randomized

Detailed Description

This multi-centre open-label Phase I/II trial evaluates feasibility, safety, dosing, and preliminary efficacy of psilocybin microdosing for psychological and existential distress in patients with advanced illness. Participants receive oral psilocybin capsules daily Monday–Friday for up to 4 weeks with a stepwise weekly dose escalation from 1 mg/day to a maximum of 3 mg/day.

Primary outcomes are feasibility metrics (recruitment and retention) and safety (adverse events); secondary outcomes include measures of depression, anxiety, well-being, and global impression of change, with pre-specified subgroup analyses for SSRI use and care setting.

Study Protocol

Preparation

sessions

Dosing

20 sessions

Integration

sessions

Therapeutic Protocol

Manualized psychotherapy included

Study Arms & Interventions

Psilocybin microdosing

experimental

Open-label single-arm psilocybin microdosing with weekly dose escalation over up to 4 weeks (Mon–Fri dosing).

Interventions

  • Psilocybin1 - 3 mg
    via Oral• daily (Mon-Fri) for up to 4 weeks• 20 doses total

    Start 1 mg/day with opportunity to increase weekly to a maximum of 3 mg/day; dosing schedule escalates across four phases.

Participants

Ages
18 – 99
Sexes
Male & Female

Inclusion Criteria

  • Inclusion Criteria:
  • 1. Patients >=18 years of age
  • 2. Advanced illness under palliative care management, defined as having 1 to <12 months life expectancy (in the judgment of the palliative care provider)
  • 3. Experiencing psychological distress, defined as a score of 7 or greater on the Depression, Anxiety or Well-being item of the Edmonton Symptom Assessment System
  • 4. Ability to understand and communicate in English or French

Exclusion Criteria

  • Exclusion Criteria:
  • 1. Current or previously diagnosed, or first-degree relative, with psychotic or bipolar disorder
  • 2. Previously deemed eligible for MAiD with intention to proceed with MAiD regardless of study intervention effectiveness
  • 3. Documented or suspected delirium in the past 3 months without a clearly defined reversible cause and resolution
  • 4. Documented moderate or severe dementia diagnosis
  • 5. Inability to provide first-person informed consent
  • 6. Severe or unstable physical symptoms based on the judgment of the palliative care provider
  • 7. Palliative Performance Scale <30%
  • 8. Cancer with known central nervous system (CNS) involvement or other CNS disease
  • 9. Use of high-dose psychedelic substances in the past year
  • 10. Taking lithium at any dose
  • 11. Taking tramadol at any dose
  • 12. Taking any monoamine oxidase inhibitor at any dose [AFHS group examples included]
  • 13. Taking any atypical antipsychotic (patients can be included if their atypical antipsychotic is stopped or substituted with haloperidol 48 hours prior to start and for duration)
  • 14. Inability to ingest oral capsule
  • 15. Pregnancy or lactation
  • Additional conditions apply for participants on SSRIs or antipsychotics (PC provider approval, stable dose, not exceeding maximum allowable trial dose). All participants must not take other psychedelics during the trial and must follow restrictions on benzodiazepine/antipsychotic timing and driving.

Study Details

Locations

The Ottawa Hospital — Ottawa, Ontario, Canada
Bruyere Continuing Care — Ottawa, Ontario, Canada

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