A Phase 2b Randomized Double-blind Placebo-controlled Multi-center Study of the Effects of Psilocybin-assisted Psychotherapy on Psychiatric and Existential Distress in Advanced Cancer

Brief description of study

This trial is designed to evaluate efficacy and psychological mechanisms of single-dose psilocybin-assisted psychotherapy (PAP) to treat psychiatric (anxiety, depression) and existential distress (demoralization, death anxiety), and quality-of-life (QOL), in 200 outpatients with late-stage or advanced cancer. The study will assess the strength and durability of therapeutic effects in a double-blind, parallel-design, placebo-controlled, two-center RCT comparing a single 25mg oral ‘high’ dose of psilocybin to a single 100mg dose of niacin (active placebo), both delivered in conjunction with a psychotherapy platform.


Clinical Study Identifier: s22-00498
ClinicalTrials.gov Identifier: NCT05398484
Principal Investigator: Stephen Ross.
Other Investigators: Joshua Siegel, Petros Dimitrios Petridis, Daniel Edward Roberts, Arum Kim, Kelley O'Donnell, Michael P. Bogenschutz, Richard J Zeifman, Kathleen M Madden.


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