Consciousness, Psilocybin, and Well-Being — CoPE Pilot  

Healthy Clinical Trial

Official title: Consciousness and Psilocybin Effects on Well-Being (The CoPE Study): Pilot Phase

Status Enrolling by invitation

Clinical Trial Summary

This study is being done to identify a dosing strategy that will allow IV psilocybin to be administered to sleeping participants without awakening them.

Clinical Trial Description

The study intervention will be psilocybin administered by the intravenous (IV) route combined with oral clonidine (hereafter "psilocybin+clonidine") in sleeping participants and psilocybin+clonidine and psilocybin alone administered to awake participants.

The study will use an adaptive design. This design will involve testing up to two psilocybin+clonidine administration protocols in asleep and awake subjects and one of two "IV psilocybin only" administration protocols in awake participants.

The first psilocybin+clonidine protocol to be tested will consist of 2 mg of psilocybin administered via IV infusion over a 2-minute period combined with 0.2 mg oral clonidine in 2 sleeping participants (Group 1A).

• Should this method allow at least 2 participants to remain asleep for at least 1-hour post-dosing and/or to have no memory of the dosing experience upon awakening, this 2-minute IV dosing strategy (co-administered with 0.2 mg of oral clonidine) will be selected for testing in 2 to 5 awake participants (Group 1B).

• Should participants fail to remain asleep during testing of the 2-minute infusion protocol, investigators will test a second protocol that will comprise a 10-minute minute IV infusion of 2 mg psilocybin combined with 0.2 mg oral clonidine in 2 to 5 asleep participants (Group 2A).

• Should at least 2 participants remain asleep for at least 1-hour post-dosing and/or have no memory of the dosing experience upon awakening, this 10-minute IV dosing strategy (co-administered with 0.2 mg of oral clonidine) will be selected for testing in 2 to 5 awake participants (Group 2B).

• If either the 2-minute or 10-minute psilocybin infusion (plus oral clonidine) protocols allow sleep maintenance, 2 to 5 participants will receive that psilocybin infusion protocol without clonidine to evaluate any potential effect of co-administered clonidine on the acute psychedelic experience in awake participants (Group 1C for 2-minute psilocybin infusion; Group 2C for 10-minute psilocybin infusion).

In addition, all participants enrolled to receive psilocybin+clonidine while asleep will also receive normal saline via IV prior to the night they receive IV psilocybin+clonidine to accommodate them to the IV procedure. For any given participant, the protocol for delivering the normal saline will be identical to the psilocybin protocol they receive (e.g., either IV saline (10 mL) over 2 minutes or IV saline (10 mL) over 10 minute IV infusion). Participants unable to remain asleep through the IV placebo administration may be discontinued from study participation at the discretion of the study team without progressing to receive a n IV dose of IV psilocybin and oral clonidine.

Adaptive Study Design Change per Protocol Amendment Approved 5/21/24 ;

Related Conditions & MeSH terms

• Healthy
• Psychedelic Experiences
• Sleep

• NCT number: NCT05592379
• Study type: Interventional
• Source: University of Wisconsin, Madison
• Status: Enrolling by invitation
• Phase: Phase 1
• Start date: November 7, 2023
• Completion date: June 2025