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.
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.
Open-label single-arm psilocybin microdosing with weekly dose escalation over up to 4 weeks (Mon–Fri dosing).
Start 1 mg/day with opportunity to increase weekly to a maximum of 3 mg/day; dosing schedule escalates across four phases.