Double-blind, randomized, parallel Phase II/III RCT (n≈300 estimated) comparing a single 25 mg oral dose of psilocybin plus psychotherapy versus a single 100 mg niacin active placebo plus psychotherapy in outpatients with advanced cancer to treat anxiety, depression and existential distress.
Multi-centre, double-blind, randomized parallel design testing single-dose psilocybin (25 mg) against an active placebo (niacin 100 mg), both delivered with a manualised psychotherapy platform in patients with stage 3–4 or advanced cancer.
The psychotherapy platform includes approximately 6 hours of preparatory therapy prior to dosing and 8 hours of integration therapy after dosing; outcomes include measures of anxiety, depression, demoralisation, death anxiety and quality of life.
Single 25 mg oral psilocybin with manualised psychotherapy platform (preparation and integration).
One 25 mg capsule administered with water.
Manualised psychotherapy platform (6 hours preparatory prior to dosing; 8 hours integration following dosing).
Single 100 mg niacin active placebo with the same manualised psychotherapy platform.
Niacin 100 mg active placebo.
Manualised psychotherapy platform (6 hours preparatory prior to dosing; 8 hours integration following dosing).