Skip to main content
OpenTrials
Not Yet Recruiting

NCT Number: NCT07360301

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

Not Yet Recruiting

Trial opening soon.

Get Notified

Key information

Conditions

Well-Being, Psychological Behavior Personal Satisfaction Psychedelic Experiences Psychological Well-Being

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

University of Wisconsin

Madison, Wisconsin, 53792, United States

About this study

Primary Objectives:

  • To evaluate the effect of psilocybin on wellbeing when administered while awake vs. while asleep
  • To evaluate the effect of psilocybin on wellbeing administered while asleep vs. placebo administered while asleep

Secondary Objectives:

  • To evaluate the effect of psilocybin on psychological flexibility when administered while awake vs. while asleep
  • To evaluate the effect of psilocybin on psychological flexibility administered while asleep vs. placebo administered while asleep
  • To evaluate the effect of psilocybin on social connectedness when administered while awake vs. while asleep
  • To evaluate the effect of psilocybin on social connectedness administered while asleep vs. placebo administered while asleep
  • To evaluate the effect on wellbeing/life satisfaction/purpose/meaning explicitly ascribed to psilocybin administered while awake vs. while asleep
  • To evaluate the effect on wellbeing/life satisfaction/purpose/meaning explicitly ascribed to psilocybin administered while asleep vs. saline placebo administered while asleep

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Psilocybin

Drug

IV administration, infusion of 3.2 mg psilocybin over 10 minutes, followed by an additional 0.8 mg infused over the following 20 minutes

Other names: intravenous psilocybin

Saline Placebo

Other

IV 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

Drug

0.2 mg of clonidine will be taken by mouth by all participants 60 minutes prior to the initial infusion on Dosing Night

Other names: Clonidine ER

Primary outcomes

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

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

    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.

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

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

    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.

Secondary outcomes

  1. Change in Brief Experiential Avoidance Questionnaire (BEAQ): Psilocybin Awake versus Asleep

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

    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.

  2. Change in Brief Experiential Avoidance Questionnaire (BEAQ): Psilocybin Asleep versus Placebo Asleep

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

    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.

  3. Change in Watts Social Connectedness (WCS) Scale: Psilocybin Awake versus Asleep

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

    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.

  4. Change in Watts Social Connectedness (WCS) Scale: Psilocybin Asleep versus Placebo Asleep

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

    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.

  5. Persisting Effects Questionnaire (PEQ): Psilocybin Awake versus Asleep

    Time frame: post-dosing Day 29

    PEQ-15 is a 15-item survey in which initial items are rated on an 8-point scale ranging from "no more than routine, everyday experiences" to "the single most meaningful experience of my life." Remaining items are rated on a 7-point scale ranging from strong negative change to strong positive change. Higher scores indicate more positive persisting effects.

    Reported here for psilocybin administered while asleep to psilocybin administered while asleep.

  6. Persisting Effects Questionnaire (PEQ): Psilocybin Asleep versus Placebo Asleep

    Time frame: post-dosing Day 29

    PEQ-15 is a 15-item survey in which initial items are rated on an 8-point scale ranging from "no more than routine, everyday experiences" to "the single most meaningful experience of my life." Remaining items are rated on a 7-point scale ranging from strong negative change to strong positive change. Higher scores indicate more positive persisting effects.

    Reported here for psilocybin administered while asleep to psilocybin administered while asleep.

Study contacts

Contact information is provided by the study sponsor or research team.

CoPEWell Study Contact

CONTACT

[email protected]

608-263-4852

Sponsors and collaborators

Lead sponsor

University of Wisconsin, Madison

Other

Collaborators

  • Tiny Blue Dot Foundation

Registry information

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Jan 22, 2026
Registry last updated
Jul 2, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.