Adaptive, non-randomised Phase I healthy volunteer study (target n=15) testing IV psilocybin 2 mg (2‑ or 10‑minute infusions) with or without 0.2 mg oral clonidine to identify regimens that permit dosing during sleep.
This adaptive sequential study evaluates IV psilocybin 2 mg administered over 2 or 10 minutes, with and without 0.2 mg oral clonidine, to determine whether dosing can be delivered to sleeping participants without awakening them.
Initial asleep cohorts receive placebo and active conditions; progression criteria determine move to awake comparator cohorts. Wake dosing may include comparisons with and without clonidine; psychosocial integration sessions follow each dosing visit.
2 mg IV psilocybin over 2 minutes with 0.2 mg oral clonidine or saline while asleep (overnight visits).
IV infusion over 2 minutes
Clonidine 0.2 mg oral given as pre-treatment
Saline placebo IV 10 mL over matched infusion time
2 mg IV psilocybin over 2 minutes with 0.2 mg oral clonidine in awake participants (if progression criteria met).
IV infusion over 2 minutes
Clonidine 0.2 mg oral
2 mg IV psilocybin over 10 minutes with 0.2 mg oral clonidine or saline while asleep (alternate initial group).
IV infusion over 10 minutes
Clonidine 0.2 mg oral
Saline placebo IV 10 mL over matched infusion time
2 mg IV psilocybin over 10 minutes with 0.2 mg oral clonidine in awake participants (if progression criteria met).
IV infusion over 10 minutes
Clonidine 0.2 mg oral
2 mg IV psilocybin over 2 minutes in awake participants (comparison without clonidine).
IV infusion over 2 minutes
2 mg IV psilocybin over 10 minutes in awake participants (comparison without clonidine).
IV infusion over 10 minutes