Participate in Research at CU Anschutz

The purpose of this trial is to study the effects of psilocybin-assisted psychotherapy to treat anxiety, depression, and existential distress (demoralization, death anxiety), and quality of life for individuals with late stage or advanced cancer, as compared to an active placebo plus psychotherapy.

This multi-center trial will enroll 200 participants across two sites. During the randomized, controlled phase of the study, participants will receive either a single 25mg oral ‘high’ dose of psilocybin or an active placebo (100mg niacin), alongside psychotherapy. During the open-label phase, participants will have the opportunity to receive a single 25mg oral ‘high’ dose of psilocybin, alongside psychotherapy.

Main Procedures Involved: A participant will be required to do the following: 1. Attend in-person visits for Screening, Baseline, medication administration, and final follow-up (two additional visits if participating in open-label). Visits will consist of: o Medical history and physical o Electrocardiogram (ECG) o Safety and laboratory assessments (including blood and urine testing) o Psychological assessments 2. Attend study visits, consisting of psychological assessments or preparatory and integration sessions with study therapists (option to be virtual) 3. Must have a support person to accompany them following the dosing session

Duration of Participation: Total study participation will be approximately 43 hours across 7 months; the extended open-label phase is approximately 27 hours across 6 months.