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Not yet recruiting NCT07360301

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

Phase I Interventional Well-Being, Psychological Psychedelic Experiences

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Psilocybin, Saline Placebo, Clonidine.
Who it may be relevant to
Registry conditions: Well-Being, Psychological, Psychedelic Experiences. Basic parameters: 18 years — 45 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Overview

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.

Detailed description

Primary Objectives:

1. To evaluate the effect of psilocybin on wellbeing when administered while awake vs. while asleep 2. To evaluate the effect of psilocybin on wellbeing administered while asleep vs. placebo administered while asleep

Secondary Objectives: 3. To evaluate the effect of psilocybin on psychological flexibility when administered while awake vs. while asleep 4. To evaluate the effect of psilocybin on psychological flexibility administered while asleep vs. placebo administered while asleep 5. To evaluate the effect of psilocybin on social connectedness when administered while awake vs. while asleep 6. To evaluate the effect of psilocybin on social connectedness administered while asleep vs. placebo administered while asleep 7. To evaluate the effect on wellbeing/life satisfaction/purpose/meaning explicitly ascribed to psilocybin administered while awake vs. while asleep 8. To evaluate the effect on wellbeing/life satisfaction/purpose/meaning explicitly ascribed to psilocybin administered while asleep vs. saline placebo administered while asleep

Interventions

  • Drug Psilocybin
    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 Saline Placebo
    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.
  • Drug Clonidine
    0.2 mg of clonidine will be taken by mouth by all participants 60 minutes prior to the initial infusion on Dosing Night

Primary outcome measures

  • Change in Warwick Edinburgh Mental Wellbeing Scale (WEMWBS) score: Psilocybin Awake versus Asleep [Time frame: Baseline 2 (Day 0) to post-dosing Day 29]
  • 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]
Secondary outcome measures (6)
  • Change in Brief Experiential Avoidance Questionnaire (BEAQ): Psilocybin Awake versus Asleep [Time frame: Baseline 2 (Day 0) to post-dosing Day 29]
  • Change in Brief Experiential Avoidance Questionnaire (BEAQ): Psilocybin Asleep versus Placebo Asleep [Time frame: Baseline 2 (Day 0) to post-dosing Day 29]
  • Change in Watts Social Connectedness (WCS) Scale: Psilocybin Awake versus Asleep [Time frame: Baseline 2 (Day 0) to post-dosing Day 29]
  • Change in Watts Social Connectedness (WCS) Scale: Psilocybin Asleep versus Placebo Asleep [Time frame: Baseline 2 (Day 0) to post-dosing Day 29]
  • Persisting Effects Questionnaire (PEQ): Psilocybin Awake versus Asleep [Time frame: post-dosing Day 29]
  • Persisting Effects Questionnaire (PEQ): Psilocybin Asleep versus Placebo Asleep [Time frame: post-dosing Day 29]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Double blind
Primary purpose
Basic science

Study locations

United States · 1 center
  • University of Wisconsin — Madison

Identifiers

NCT: NCT07360301 · 2025-1861 · SMPH | Psychiatry · Protocol Version 12/18/25

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗