Well-Being, PsychologicalPhase 1NCT07360301
Consciousness and Psilocybin Effects on Well-Being: The CoPEWell Study
A Phase 1 study testing Psilocybin and Clonidine in people with Well-Being, Psychological and Psychedelic Experiences, run by University of Wisconsin, Madison at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Well-Being, Psychological, Psychedelic Experiences
- What is being tested?
- Psilocybin and Clonidine
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 120 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2027to Jun 2028
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this 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.
Read the detailed description
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
- Conditions
- Well-Being, Psychological, Psychedelic Experiences
- Being tested
- Psilocybin, Saline Placebo, Clonidine
- Medical subject headings
- Psychological Well-Being
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PsilocybinDrug
Also called intravenous 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
Saline PlaceboOther
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.
ClonidineDrug
Also called Clonidine ER
0.2 mg of clonidine will be taken by mouth by all participants 60 minutes prior to the initial infusion on Dosing Night
| Study group | Role | What they receive |
|---|---|---|
| Psilocybin While Awake, Placebo While Asleep | Experimental | 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. Receives: Drug: Psilocybin; Other: Saline Placebo; Drug: Clonidine |
| Placebo While Awake, Psilocybin While Asleep | Experimental | 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. Receives: Drug: Psilocybin; Other: Saline Placebo; Drug: Clonidine |
| Placebo While Awake, Placebo While Asleep | Placebo comparator | 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. Receives: Other: Saline Placebo; Drug: Clonidine |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Baseline 2 (Day 0) to post-dosing Day 29
Secondary outcomes (6)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: post-dosing Day 29
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2026
- Study startFeb 2027 (estimated)
- Primary completionJun 2028 (estimated)
- Study completionJun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Well-Being, PsychologicalStudies of the same condition, open and under way.
- More trials run by University of Wisconsin, MadisonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Wisconsin, Madison
- Sponsor type
- University, hospital or other
- Collaborators
- Tiny Blue Dot Foundation, Advanced Research Projects Agency for Health (ARPA-H)
- Responsible party
- Sponsor
- Investigators
- Charles Raison, MD, Principal investigator, University of Wisconsin, Madison
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07360301
- Sponsor's protocol ID
- 2025-1861
- Other IDs
- SMPH | Psychiatry, Protocol Version 12/18/25
- Status last verified
- Jun 2026
- First submitted
- 13 Jan 2026
- Last updated
- 30 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- 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.
Study at a glance
From the registry record, last updated by the sponsor on 30 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Consciousness and Psilocybin Effects on Well-Being: The CoPEWell Study
- ClinicalTrials.gov ID
- NCT07360301
- Acronym / sponsor ID
- 2025-1861
- Conditions
- Well-Being, Psychological, Psychedelic Experiences
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- University of Wisconsin, MadisonUniversity, hospital or other
- Collaborators
- Tiny Blue Dot Foundation, Advanced Research Projects Agency for Health (ARPA-H)
- Study start
- Feb 2027 (estimated)
- Primary completion
- Jun 2028 (estimated)
- Study completion
- Jun 2028 (estimated)
- First posted
- 22 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Psilocybin While Awake, Placebo While Asleep | Experimental | Drug: Psilocybin, Other: Saline Placebo, Drug: ClonidineParticipants 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. |
| Placebo While Awake, Psilocybin While Asleep | Experimental | Drug: Psilocybin, Other: Saline Placebo, Drug: ClonidineParticipants 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. |
| Placebo While Awake, Placebo While Asleep | Placebo comparator | Other: Saline Placebo, Drug: ClonidineParticipants 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. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PsilocybinAlso: intravenous psilocybinIV administration, infusion of 3.2 mg psilocybin over 10 minutes, followed by an additional 0.8 mg infused over the following 20 minutes | Drug | Placebo While Awake, Psilocybin While Asleep, Psilocybin While Awake, Placebo While Asleep |
| Saline PlaceboIV 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. | Other | Placebo While Awake, Placebo While Asleep, Placebo While Awake, Psilocybin While Asleep, Psilocybin While Awake, Placebo While Asleep |
| ClonidineAlso: Clonidine ER0.2 mg of clonidine will be taken by mouth by all participants 60 minutes prior to the initial infusion on Dosing Night | Drug | Placebo While Awake, Placebo While Asleep, Placebo While Awake, Psilocybin While Asleep, Psilocybin While Awake, Placebo While Asleep |
Primary outcome
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.
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.
6 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Oct 2026.
- Individual participant dataSharing planned: 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Charles Raison, MD principal investigator
University of Wisconsin, Madison
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Psilocybin and Clonidine in people with Well-Being, Psychological and Psychedelic Experiences, run by University of Wisconsin, Madison at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 30 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact CoPEWell Study Contact (608-263-4852, copewell@psychiatry.wisc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Warwick Edinburgh Mental Wellbeing Scale (WEMWBS) score: Psilocybin Awake versus Asleep (time frame: Baseline 2 (Day 0) to post-dosing Day 29). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Oct 2026.