This Phase I, single-group trial (n=40) will assess the safety and tolerability of oral psilocybin in healthy older adults aged 65 to 85 years. It will evaluate two dose cohorts, with the main aim of determining whether psilocybin can be administered safely in this population and how it is tolerated over time. Participants will receive two escalating oral doses of psilocybin 30 days apart: Cohort 1a will receive 10 mg followed by 25 mg, and Cohort 1b will receive 15 mg followed by 30 mg. The study will also examine pharmacokinetics, patient-reported outcomes such as psychedelic experience and wellbeing, and relationships between drug exposure, safety findings, and reported effects. Safety outcomes include adverse events assessed for up to 14 weeks.
This study plans to learn more about the safety and tolerability of psychedelic administration (psilocybin) in healthy older adults ages 65-85.
Two escalating doses of psilocybin 30 days apart