Psilocybin-assisted Psychotherapy on Psychiatric and Existential Distress in Advanced Cancer ***Cancer Diagnosis Only***
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.
Why this Research Matters
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.
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
Total study participation will be approximately 43 hours across 7 months; the extended
open-label phase is approximately 27 hours across 6 months.
Diagnosis of advanced cancer
Ongoing depression/anxiety/demoralization.
General overall ability to function and no major organ failure
More information available at ClinicalTrials.gov:
NCT05398484
