Clinical Trial

Psilocybin Therapy in Advanced Cancer

Recruiting Phase 2/3
View on ClinicalTrials.gov →
Summary
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.
Protocol Amendment History 10 amendments
This ClinicalTrials.gov record has been amended 10 times since 2022-05-26; most recent amendment 2025-12-02.
Status change: Not Yet Recruiting → Recruiting 2023-05-04
Trial Details
NCT Number NCT05398484
Lead Sponsor NYU Langone Health
Collaborators: National Cancer Institute (NCI)
Conditions Advanced Cancer
Enrollment 200 participants
Start Date 2023-05-24
Primary Completion 2027-01-01 (estimated)
Study Completion 2027-01-01 (estimated)
Updated on ClinicalTrials.gov 2025-12-04