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

The purpose of this research is to study the safety and effects of single-dose psilocybin 25mg versus an active placebo (single dose niacin 100mg) in the treatment of anxiety, depression, and existential distress (i.e., loss of meaning and hope; fear of death) in advanced cancer (i.e., stage 3 or 4). Study medications will be administered in conjunction with brief psychotherapy that is designed to treat anxiety, depression and existential distress in advanced cancer. Participant involvement will be ~6.5 months from consent, enrollment, and randomization to the final integrative session. There will be preparatory and post-drug integration sessions for both groups. The manualized structure of preparatory and integrative sessions is identical for both study arms.




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