Clinical trial NCT05592379: Consciousness, Psilocybin, and Well-Being
Official title: Consciousness and Psilocybin Effects on Well-Being (The CoPE Study): Pilot Phase
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Psychedelic Experiences
Sleep
Keywords: Sleep
Psilocybin
Psychedelics
Healthy Volunteer
Lead sponsor: University of Wisconsin, Madison
Sponsor class: OTHER
Collaborators: name: Usona Institute
name: Tiny Blue Dot Foundation
First posted: 2022-10-24
Enrollment: 6
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Intervention model description: placebo first followed by placebo+clonidine or psilocybin+clonidine in asleep healthy volunteers
Primary purpose: BASIC_SCIENCE

Brief 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.

Detailed description: The study commenced with 1 subject receiving 2 mg IV infusion of psilocybin over 2 minutes and 2 subjects receiving 2 mg IV infusion of psilocybin over 10 minutes. Subsequently, the pre-treatment of 0.2 mg of clonidine was added.

This design involves testing up to two psilocybin+clonidine administration protocols in asleep and awake subjects and one of two "IV psilocybin only" administration protocols in awake subjects.

The updated protocol entails 2 mg of psilocybin administered via IV infusion combined with 0.2 mg oral clonidine in sleeping subjects. If either the 2-minute or 10-minute psilocybin infusion (plus oral clonidine) protocols allow sleep maintenance, up to 5 subjects will, while awake, receive the same psilocybin infusion protocol administered to sleeping subjects, including clonidine. Subsequently, this same infusion protocol may be administered without clonidine, to evaluate any potential effect of co-administered clonidine on the acute psychedelic experience in awake subjects (Group 1C for 2-minute psilocybin infusion; Group 2C for 10-minute psilocybin infusion), should a significant effect of clonidine on the awake psychedelic experience be suspected. For individual subjects that are dosed first while asleep and then up to twice while awake, each of their visits will be separated by a minimum of two weeks and will include psychosocial support through integration sessions following each dosing visit.

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

Eligibility criteria: Inclusion Criteria:

* Medically healthy
* English-speaking
* Live within 150 miles of Madison, WI for duration of study

Exclusion Criteria:

* Current use of medications that may interact with psilocybin
* Current sleep disorder, including (but not limited to) insomnia, sleep apnea, restless legs syndrome, and/or narcolepsy
* Females with positive urine pregnancy at any time point during screening or study participation
* Current cardiac valve disease

Primary outcomes:
measure: Number and nature of adverse events associated with the administration of a single dose of IV psilocybin
timeFrame: Up to 9 days
Secondary outcomes:
measure: Number of participants administered psilocybin plus clonidine while asleep who remain asleep for at least 1 hour post dosing and/or report no memory of the dosing experience upon awakening
timeFrame: 1 day
measure: Post-dosing scores on the 30-item Mystical Experiences Questionnaire (MEQ30) following administration of psilocybin and clonidine while asleep or awake
timeFrame: 1 day
measure: Post-dosing scores on the Emotional Breakthrough Inventory (EBI) following administration of IV psilocybin either alone or in combination with clonidine while awake
timeFrame: 1 day
measure: Post-dosing scores on the Psychological Insight Scale (PIS) following administration of IV psilocybin either alone or in combination with clonidine while awake
timeFrame: 1 day
measure: Post-dosing scores on the Ego Dissolution Inventory (EDI) following administration of IV psilocybin either alone or in combination with clonidine while awake
timeFrame: 1 day
measure: Post-dosing scores on the Awe Experiences Scale (AWE) following administration of IV psilocybin either alone or in combination with clonidine while awake
timeFrame: 1 day
measure: Post-dosing scores on the Altered States of Consciousness Questionnaire (ASC) following administration of IV psilocybin while either alone or in combination with clonidine while awake
timeFrame: 1 day
measure: Post-dosing scores on the Challenging Experiences Questionnaire (CEQ) following administration of IV psilocybin either alone or in combination with clonidine while awake
timeFrame: 1 day
measure: Warwick-Edinburgh Mental Well-Being Scale (WEMWBS) score 7 days post administration of IV psilocybin either alone or in combination with clonidine while awake
timeFrame: Up to 19 days
measure: World Health Organization Well-Being Index
timeFrame: Up to 19 days
Other outcomes:
Locations:
city: Madison
country: United States
facility: University of Wisconsin Hospital and Clinics
state: Wisconsin
Study officials:
affiliation: University of Wisconsin, Madison
name: Charles Raison, MD
role: PRINCIPAL_INVESTIGATOR
References: