Start
•
Completion

Consciousness and Psilocybin Effects on Well-Being: Pilot Phase (CoPE Pilot)

Not yet recruitingRegisteredCTG

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.

Details

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.

Topics:Healthy Volunteers

Registry

Registry linkNCT05592379