Psilocybin Therapy in Advanced Cancer
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.
Details
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.