PSilocybin for psYCHological and Existential Distress in PALliative Care (PSYCHED-PAL)

Summary

The goal of this multi-centre phase I/II open-label, single-arm study is to determine the safety, feasibility, therapeutic dose, and preliminary efficacy of psilocybin microdosing to treat psychological distress among patients with advanced illness. Forty patients will receive psilocybin drug product (1-3mg per day, Mon-Fri) for 4 weeks to be administered via oral capsules by the participant. Feasibility (recruitment rate, rate of intervention and follow-up completion), safety (rate of adverse events), dosing, and preliminary efficacy (depression, anxiety, overall well-being, and global impression of change) will be measured.

Conditions

• Depression, Anxiety
• Distress, Emotional

Interventions

DRUG

Psilocybin

Phase 1 (week 1): all enrolled participants will take a single 1mg oral dose of psilocybin once per day on Monday and Thursday. If no adverse events are reported at any point during the week (Mon-Fri), the participant will continue to Phase 2 for week 2. Phase 2: The participant will take a single 1mg oral dose of psilocybin once per day for 5 consecutive days (Monday to Friday). If no adverse events are reported at any point during the week (Mon-Fri), the participant will continue to Phase 3 for week 3. Phase 3: The participant will take two 1mg oral doses (2mg total) of psilocybin once per day for 5 consecutive days (Monday to Friday). If no adverse events are reported at any point during the week (Mon-Fri), the participant will continue to Phase 4 for week 4. Phase 4 (maximum allowable dose): The participant will take three 1mg oral doses (3mg total) of psilocybin once per day for 5 consecutive days (Monday to Friday).

Sponsors & Collaborators

• Bruyère Health Research Institute.

  collaborator OTHER

• The Ottawa Hospital

  collaborator OTHER

• St. Joseph's Healthcare Hamilton

  collaborator OTHER

• CHU de Quebec-Universite Laval

  collaborator OTHER

• Centre de recherche du Centre hospitalier universitaire de Sherbrooke

  collaborator OTHER

• Jewish General Hospital

  collaborator OTHER

• William Osler Health System

  collaborator OTHER

• Queen's University

  collaborator OTHER

• Ottawa Hospital Research Institute

  lead OTHER

Principal Investigators

• James Downar, MDCM, MSc · The Ottawa Hospital Research Institute

Study Design

Allocation

NA

Purpose

TREATMENT

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2024-01-08

Primary Completion

2025-01-31

Completion

2025-06-30

Countries

• Canada

Study Locations