This single-blind interventional trial (n=20) will investigate the safety of ascending doses of psilocybin for home administration.
Randomised, sequential laboratory study in healthy volunteers (n=20) testing ascending microdoses of psilocybin trihydrate (1.2, 2.0, 3.0, 4.2 mg) with a single interspersed randomized placebo session to identify the highest safe at-home dose.
Five double-blind laboratory dosing sessions will include baseline measures and safety assessments; each session assesses criteria for safe home dosing and questionnaires to monitor acute effects and adverse events.
If a safe at-home dose is identified for all participants after completing all sessions, that dose will be considered the highest safe dose for future studies.
Single microdose psilocybin trihydrate 1.2 mg oral capsule (laboratory session).
Psilocybin trihydrate 1.2 mg (microdose).
Single microdose psilocybin trihydrate 2.0 mg oral capsule (laboratory session).
Psilocybin trihydrate 2.0 mg (microdose).
Single microdose psilocybin trihydrate 3.0 mg oral capsule (laboratory session).
Psilocybin trihydrate 3.0 mg (microdose).
Single microdose psilocybin trihydrate 4.2 mg oral capsule (laboratory session).
Psilocybin trihydrate 4.2 mg (microdose).
Single placebo oral capsule identical in appearance to active capsules.
Randomised interspersed placebo session.