A Phase 1 interventional study of Psilocybin and Saline Placebo in Well-Being, Psychological and Psychedelic Experiences, sponsored by University of Wisconsin, Madison. Not yet recruiting at 1 site in United States. Open to participants aged 18 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-09-29.
Sponsored by University of Wisconsin, Madison · Phase 1, Interventional, and Basic science
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.
Primary Objectives:
To evaluate the effect of psilocybin on wellbeing administered while asleep vs. placebo administered while asleep
Secondary Objectives:
Exclusion Criteria:
Participants in this group will receive psilocybin by intravenous (IV) infusion while awake and placebo (saline) by IV infusion while asleep during an overnight dosing visit. All participants will also receive oral clonidine prior to dosing to support sleep during the overnight visit.
Drug: Psilocybin · Other: Saline Placebo · Drug: Clonidine
Participants in this group will receive placebo (saline) by intravenous (IV) infusion while awake and psilocybin by IV infusion while asleep during an overnight dosing visit. All participants will also receive oral clonidine prior to dosing to support sleep during the overnight visit.
Drug: Psilocybin · Other: Saline Placebo · Drug: Clonidine
Participants in this group will receive placebo (saline) by intravenous (IV) infusion while awake and placebo by IV infusion while asleep during an overnight dosing visit. All participants will also receive oral clonidine prior to dosing to support sleep during the overnight visit.
Other: Saline Placebo · Drug: Clonidine
IV administration, infusion of 3.2 mg psilocybin over 10 minutes, followed by an additional 0.8 mg infused over the following 20 minutes
Also known as: intravenous psilocybin
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.
0.2 mg of clonidine will be taken by mouth by all participants 60 minutes prior to the initial infusion on Dosing Night
Also known as: Clonidine ER
Change in Warwick Edinburgh Mental Wellbeing Scale (WEMWBS) score: Psilocybin Awake versus Asleep
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.
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
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.
Time frame: Baseline 2 (Day 0) to post-dosing Day 29
Change in Brief Experiential Avoidance Questionnaire (BEAQ): Psilocybin Awake versus Asleep
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.
Time frame: Baseline 2 (Day 0) to post-dosing Day 29
Change in Brief Experiential Avoidance Questionnaire (BEAQ): Psilocybin Asleep versus Placebo Asleep
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.
Time frame: Baseline 2 (Day 0) to post-dosing Day 29
Change in Watts Social Connectedness (WCS) Scale: Psilocybin Awake versus Asleep
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.
Time frame: Baseline 2 (Day 0) to post-dosing Day 29
Change in Watts Social Connectedness (WCS) Scale: Psilocybin Asleep versus Placebo Asleep
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.
Time frame: Baseline 2 (Day 0) to post-dosing Day 29
Persisting Effects Questionnaire (PEQ): Psilocybin Awake versus Asleep
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.
Time frame: post-dosing Day 29
Persisting Effects Questionnaire (PEQ): Psilocybin Asleep versus Placebo Asleep
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.
Time frame: post-dosing Day 29
Plan to share: Yes — De-identified individual participant data (IPD) will be made available to qualified researchers for research purposes. Data will be shared in accordance with applicable funder requirements, institutional policies, and regulatory obligations, including deposition in a designated data repository when required. Otherwise, data will be shared upon reasonable request following publication of primary study results, subject to institutional review and approval.
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University of Wisconsin, Madison