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| ID | Type | Description | Link |
|---|---|---|---|
| SMPH | Psychiatry | Other Identifier | UW Madison | |
| Protocol Version 12/18/25 | Other Identifier | UW Madison |
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| Name | Class |
|---|---|
| Tiny Blue Dot Foundation | OTHER |
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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 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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 |
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| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | Baseline 2 (Day 0) to post-dosing Day 29 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline 2 (Day 0) to post-dosing Day 29 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| CoPEWell Study Contact | Contact | 608-263-4852 | copewell@psychiatry.wisc.edu |
| Name | Affiliation | Role |
|---|---|---|
| Charles Raison, MD | University of Wisconsin, Madison | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Wisconsin | Madison | Wisconsin | 53792 | United States |
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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Data will be available beginning after publication of primary study results and following completion of data quality control and de-identification procedures.
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.
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| ID | Term |
|---|---|
| D000092862 | Psychological Well-Being |
| ID | Term |
|---|---|
| D010549 | Personal Satisfaction |
| D001519 | Behavior |
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| ID | Term |
|---|---|
| D011562 | Psilocybin |
| D003000 | Clonidine |
| ID | Term |
|---|---|
| D026121 | Indole Alkaloids |
| D000470 | Alkaloids |
| D006571 | Heterocyclic Compounds |
| D007211 | Indoles |
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| 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. |
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| 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 |
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| 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. | 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. | 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. | 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. | 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. | post-dosing Day 29 |
| D006574 |
| Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D014363 | Tryptamines |
| D054836 | Indolizidines |
| D007212 | Indolizines |
| D048288 | Imidazolines |
| D007093 | Imidazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |