Consciousness and Psilocybin Effects on Well-Being: The CoPEWell Study
Trial statusNot yet recruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-45
SponsorUniversity of Wisconsin, Madison
About this trial
This study is exploring how psilocybin (a psychedelic drug) may improve mood and wellbeing. Many people report feeling better after taking psilocybin, but it is not clear why. The CoPEWell study will test whether these improvements come from the psychedelic experience itself (the "trip") or from direct effects on the brain. To study this, up to 120 participants will be enrolled to receive psilocybin either while awake or asleep and can expect to be on study for up to 4 months.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Age 18 to 45 years (inclusive) at screening, of any identified gender and racial/ethnic group
Physically healthy; does not meet criteria for an exclusionary medical condition
No exclusionary sleep condition
English-speaking (able to provide consent and complete questionnaires)
Disqualifiers
Exclusionary DSM-5 psychiatric diagnosis and/or active suicidal ideation
Exclusionary medical conditions or sleep conditions
Clinically significant safety lab abnormalities (i.e., Complete Blood Count with Differential, Comprehensive Metabolic Panel, and urinalysis)
Clinically significant electrocardiogram (ECG)
Trial design
Design model
Parallel
Treatments tested in this trial
Psilocybin
DrugIV administration, infusion of 3.2 mg psilocybin over 10 minutes, followed by an additional 0.8 mg infused over the following 20 minutes
Saline Placebo
Other interventionIV administration, placebo will be 20 mL of saline drawn up aseptically into the same sized (30 mL) syringe as is used for the active drug.
Clonidine
Drug0.2 mg of clonidine will be taken by mouth by all participants 60 minutes prior to the initial infusion on Dosing Night
Treatment groups
120 Participants
are divided into 3 treatment groupsGroup A: Psilocybin While Awake, Placebo While AsleepExperimental treatment 3 interventions
Group B: Placebo While Awake, Psilocybin While AsleepExperimental treatment 3 interventions
Group C: Placebo While Awake, Placebo While AsleepPlacebo comparator 2 interventions
Trial outcomes
Primary outcomes
1
Change in Warwick Edinburgh Mental Wellbeing Scale (WEMWBS) score: Psilocybin Awake versus Asleep
WEMWBS is a 14-item survey scored on a 5 point likert scale. The total range in scores is from 14 to 70 where higher scores indicate better mental wellbeing. Reported here for psilocybin administered while awake to psilocybin administered while asleep.
Time frame
Baseline 2 (Day 0) to post-dosing Day 292
Change in Warwick Edinburgh Mental Wellbeing Scale (WEMWBS) score: Psilocybin Asleep versus Placebo Asleep
WEMWBS is a 14-item survey scored on a 5 point likert scale. The total range in scores is from 14 to 70 where higher scores indicate better mental wellbeing. Reported here for psilocybin administered while asleep to and placebo administered while asleep.
Time frame
Baseline 2 (Day 0) to post-dosing Day 29Secondary outcomes
1
Change in Brief Experiential Avoidance Questionnaire (BEAQ): Psilocybin Awake versus Asleep
BEAQ is 15-item survey scored on a 6 point likert scale. The total range is scores if from 15 to 90 where higher scores indicating greater avoidance. Reported here for psilocybin administered while awake to psilocybin administered while asleep.
Time frame
Baseline 2 (Day 0) to post-dosing Day 292
Change in Brief Experiential Avoidance Questionnaire (BEAQ): Psilocybin Asleep versus Placebo Asleep
BEAQ is 15-item survey scored on a 6 point likert scale. The total range is scores if from 15 to 90 where higher scores indicating greater avoidance. Reported here for psilocybin administered while asleep to placebo administered while asleep.
Time frame
Baseline 2 (Day 0) to post-dosing Day 293
Change in Watts Social Connectedness (WCS) Scale: Psilocybin Awake versus Asleep
WCS is a 19-item survey scored on a visual analog scale. Scores are reported from 0-100 where higher scores interpreted to be more connectedness to others. Reported here for psilocybin administered while awake to psilocybin administered while asleep.
Time frame
Baseline 2 (Day 0) to post-dosing Day 294
Change in Watts Social Connectedness (WCS) Scale: Psilocybin Asleep versus Placebo Asleep
WCS is a 19-item survey scored on a visual analog scale. Scores are reported from 0-100 where higher scores interpreted to be more connectedness to others. Reported here for psilocybin administered while asleep to placebo administered while asleep.
Time frame
Baseline 2 (Day 0) to post-dosing Day 29Sponsors and contacts
Click on the lead sponsor to view all of their trials.
University of Wisconsin, Madison
Lead sponsor
Tiny Blue Dot Foundation
Collaborator
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: