Not Yet RecruitingPhase 1

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

United States120 participantsStarted 2026-06

Plain-language 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.

Who can participate

Age range18 Years – 45 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

Change in Warwick Edinburgh Mental Wellbeing Scale (WEMWBS) score: Psilocybin Awake versus Asleep

Timeframe: Baseline 2 (Day 0) to post-dosing Day 29

Change in Warwick Edinburgh Mental Wellbeing Scale (WEMWBS) score: Psilocybin Asleep versus Placebo Asleep

Timeframe: Baseline 2 (Day 0) to post-dosing Day 29

Trial details

NCT IDNCT07360301

SponsorUniversity of Wisconsin, Madison

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2028-02

Contact for this trial

CoPEWell Study Contact

608-263-4852 copewell@psychiatry.wisc.edu

View on ClinicalTrials.gov More Well-Being, Psychological trials

Plain-language summary

Who can participate

Age range18 Years – 45 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Change in Warwick Edinburgh Mental Wellbeing Scale (WEMWBS) score: Psilocybin Awake versus Asleep

Timeframe: Baseline 2 (Day 0) to post-dosing Day 29

Change in Warwick Edinburgh Mental Wellbeing Scale (WEMWBS) score: Psilocybin Asleep versus Placebo Asleep

Timeframe: Baseline 2 (Day 0) to post-dosing Day 29