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Not yet recruitingPhase 1

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

NCT07360301 · University of Wisconsin, Madison

Closed to entry
Status
Not accepting participants
Phase 1
Phase
120
Target enrolment
1
Study sites
1 US states

What it is testing

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.

Summary as written by the trial’s own sponsor and published on ClinicalTrials.gov API v2. It is the sponsor’s description, reproduced unedited, not an assessment by this site.

What counts as success

Primary outcome measures

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

    Measured over Baseline 2 (Day 0) to post-dosing Day 29

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

    Measured over Baseline 2 (Day 0) to post-dosing Day 29

A trial succeeds or fails on its primary outcome, declared in advance. Everything else it reports is secondary by definition.

Who can take part

Eligibility, as published

18 Years to 45 Years
Ages
All
Sex
Accepted
Healthy volunteers
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

Where

1 study site

FacilityCityRegionCountry
University of WisconsinMadisonWisconsinUnited States

On the registry

Contact the trial directly

This site does not enrol anyone and is not involved in this trial. To ask about taking part, use the sponsor’s own contact details on the official registry record, which is also where the most current version of everything above lives.

Before you do, the preparation checklist lists what a site will ask you on a first call and what is worth asking them. It is free and collects nothing.

NCT07360301 on ClinicalTrials.gov →

Last updated in the registry 2026-07-02. Registry records change; this page reflects the data build of 2026-08-25.

Related

Where this trial sits

Substance

Recruiting in

All 10 trials from University of Wisconsin, Madison →