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NCT07360301
Consciousness and Psilocybin Effects on Well-Being: The CoPEWell Study
Conditions: Well-Being, Psychological, Psychedelic Experiences
Sex: All
Ages: 18 Years – 45 Years
Healthy volunteers: Yes
Phase: PHASE1
Enrollment: 120
Sponsor: University of Wisconsin, Madison
Location: University of Wisconsin Madison Wisconsin
Summary
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
Inclusion Criteria:
* 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)
* Sub-optimal self-reported wellbeing
Exclusion Criteria:
* 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)
* Use of psychotropic or CNS-altering medications within 3 months of screening
* Hypertension or tachycardia
Source: ClinicalTrials.gov (NCT07360301). StuddyBuddy aggregates publicly available trial information.