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 2026-10-30.
Sponsored by University of Wisconsin, Madison · Phase 1, Interventional, and Basic science
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Among 11 studies in Psychological Well-Being by University of Wisconsin, Madison — 1 open to participants now, 1 under way, none of them phase 3. Psychological Well-Being · University of Wisconsin, Madison.
Among the 11 studies in Psychological Well-Being by University of Wisconsin, Madison, this one is the 5th largest by planned enrollment of the 10 interventional ones that give a count, is the only one that started in 2027, is the only one in phase 1, and was the 11th registered.
2,197 studies on the registry are indexed under Psychological Well-Being; 729 are open to participants now.
Browse Psychological Well-Being studies →1 of the 11 studies in Psychological Well-Being by University of Wisconsin, Madison is open now, in 1 country.
By country, each count listing its studies:
Of the 400 Psychological Well-Being studies recruiting now, 218 (55%) set no upper age limit and 156 (39%) stop at 75 or younger; 119 take children under 18; 203 take healthy volunteers.
This study: 18 Years to 45 Years · all sexes · healthy volunteers too.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
11 studies; the count open now beside each. This study's row is marked.
First in 2009; this study’s year is marked. 1 started in 2027.
By drug class, each counting the studies that test any of its medicines:
This study's planned enrollment of 120 is close to the median of 110 across 1,799 interventional studies indexed under Psychological Well-Being.
Median enrollment 118 across the 10 interventional studies, 14 across the 1 observational. Of the 10 that completed or were terminated, 0 (0%) have results posted.
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University of Wisconsin, Madison is the lead sponsor of 1,189 studies on the registry; 182 are open to participants now.
Of its 157 completed or terminated interventional studies of FDA-regulated products, 118 (75%) have results posted.
None of the studies under way reaches primary completion within a year.
Among the 11 studies in Psychological Well-Being by University of Wisconsin, Madison, from their registry updates:
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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:
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
DSM diagnostic criteria
The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECG (electrocardiogram)
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Time frame: Data will be available beginning after publication of primary study results and following completion of data quality control and de-identification procedures.
Access criteria: Access will be granted to qualified investigators for scientifically valid research proposals, subject to review and approval by the study team and the University of Wisconsin-Madison, and execution of a data use agreement as required.
No publications or documents are linked to this record.
Start is estimated for Feb 2027; primary completion for Jun 2028, 16 months later.
Start moved twice since we started tracking on Sep 25, 2026: Sep 2026 → Feb 2027, last on Oct 30, 2026.
Primary completion moved once since we started tracking on Sep 25, 2026: Feb 2028 → Jun 2028, on Oct 30, 2026.
Completion moved once since we started tracking on Sep 25, 2026: Feb 2028 → Jun 2028, on Oct 30, 2026.
Earlier changes are on the record history on ClinicalTrials.gov ↗
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Jun 2026. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Psilocybin
University of Wisconsin, Madison →