Not Yet RecruitingPhase 1psilocybin

Consciousness and Psilocybin Effects on Well-Being: The CoPEWell Study

NCT ID

NCT07360301

Target Enrollment

120 participants

Start Date

2026-04

Est. Completion

2028-02

About This Study

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.

Conditions Studied

Well-Being, PsychologicalPsychedelic Experiences

Interventions

•Psilocybin
•Saline Placebo
•Clonidine

Eligibility

Age:18 Years - 45 Years

Healthy Volunteers:Yes

View full 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

Study Locations (1)

University of Wisconsin

Madison, Wisconsin, United States