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

PHASE1/PHASE2RecruitingINTERVENTIONAL
Enrollment

20

Participants

Timeline

Start Date

January 8, 2024

Primary Completion Date

January 31, 2025

Study Completion Date

June 30, 2025

Conditions
Depression, AnxietyDistress, 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)."

Trial Locations (2)

K1H 8L6

RECRUITING

The Ottawa Hospital, Ottawa

K1R 6K9

RECRUITING

Bruyere Continuing Care, Ottawa

All Listed Sponsors
collaborator

Bruyère Health Research Institute.

OTHER

collaborator

The Ottawa Hospital

OTHER

collaborator

St. Joseph's Healthcare Hamilton

OTHER

collaborator

CHU de Quebec-Universite Laval

OTHER

collaborator

Centre de recherche du Centre hospitalier universitaire de Sherbrooke

OTHER

collaborator

Jewish General Hospital

OTHER

collaborator

William Osler Health System

OTHER

collaborator

Queen's University

OTHER

lead

Ottawa Hospital Research Institute

OTHER