HealthyPhase 1CoPE PilotNCT05592379
Consciousness, Psilocybin, and Well-Being
A Phase 1 study testing Psilocybin, Clonidine and Saline in people with Healthy and Psychedelic Experiences, run by University of Wisconsin, Madison at 1 site in United States.
Trial summary
This study is being done to identify a dosing strategy that will allow IV psilocybin to be administered to sleeping participants without awakening them. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy, Psychedelic Experiences, Sleep
- What is being tested?
- Psilocybin, Clonidine and Saline
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Nov 2023to 19 Feb 2025
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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
- Medically healthy
- English-speaking
- Live within 150 miles of Madison, WI for duration of study
Who cannot join
- Current use of medications that may interact with psilocybin
- Current sleep disorder, including (but not limited to) insomnia, sleep apnea, restless legs syndrome, and/or narcolepsy
- Females with positive urine pregnancy at any time point during screening or study participation
- Current cardiac valve disease
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Wisconsin Hospital and Clinics
Madison, Wisconsin, 53715
About this study
Official title: Consciousness and Psilocybin Effects on Well-Being (The CoPE Study): Pilot Phase
This study is being done to identify a dosing strategy that will allow IV psilocybin to be administered to sleeping participants without awakening them.
Read the detailed description
The study commenced with 1 subject receiving 2 mg IV infusion of psilocybin over 2 minutes and 2 subjects receiving 2 mg IV infusion of psilocybin over 10 minutes. Subsequently, the pre-treatment of 0.2 mg of clonidine was added.
This design involves testing up to two psilocybin+clonidine administration protocols in asleep and awake subjects and one of two "IV psilocybin only" administration protocols in awake subjects.
The updated protocol entails 2 mg of psilocybin administered via IV infusion combined with 0.2 mg oral clonidine in sleeping subjects. If either the 2-minute or 10-minute psilocybin infusion (plus oral clonidine) protocols allow sleep maintenance, up to 5 subjects will, while awake, receive the same psilocybin infusion protocol administered to sleeping subjects, including clonidine. Subsequently, this same infusion protocol may be administered without clonidine, to evaluate any potential effect of co-administered clonidine on the acute psychedelic experience in awake subjects (Group 1C for 2-minute psilocybin infusion; Group 2C for 10-minute psilocybin infusion), should a significant effect of clonidine on the awake psychedelic experience be suspected. For individual subjects that are dosed first while asleep and then up to twice while awake, each of their visits will be separated by a minimum of two weeks and will include psychosocial support through integration sessions following each dosing visit.
Adaptive Study Design Change per Protocol Amendment Approved 5/21/24
- Conditions
- Healthy, Psychedelic Experiences, Sleep
- Being tested
- Psilocybin, Clonidine, Saline
- Keywords
- Sleep, Psilocybin, Psychedelics, Healthy Volunteer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PsilocybinDrug
Also called Psilocybine, Psilocibin
The IV formulation of psilocybin will be prepared using bulk psilocybin that will satisfy Good Manufacturing Practice (GMP) criteria. The IV psilocybin solution will be prepared under sterile conditions by the University of Wisconsin Pharmaceutical Research Center (PRC).
ClonidineDrug
Clonidine will be administered orally in a 0.2mg dose
SalineOther
Also called Placebo
The IV placebo (saline) will be prepared under sterile conditions by the University of Wisconsin Pharmaceutical Research Center.
| Study group | Role | What they receive |
|---|---|---|
| Group 1A: 2-minute IV Psilocybin+Clonidine / Saline in Asleep Participants | Experimental | Participants will receive 10 mL of placebo (saline) over 2 minutes while asleep during their first overnight visit. Participants will receive 0.2 mg oral clonidine and either 2 mg of IV psilocybin or saline over 2 minutes while asleep during their second overnight visit. Receives: Drug: Psilocybin; Drug: Clonidine; Other: Saline |
| Group 1B: 2-minute IV Psilocybin+Clonidine Infusion in Awake Participants | Experimental | If Group 1A participants can sleep 1 hour post-dosing and/or have no memory of dosing, Group 1B moves forward and participants will receive 0.2 mg clonidine and 2 mg of IV psilocybin over 2 minutes while awake. Receives: Drug: Psilocybin; Drug: Clonidine |
| Group 2A: 2-minute IV Psilocybin+Clonidine / Saline in Asleep Participants | Experimental | If Group 1A participants fail to sleep 1 hour post-dose, Group 2A moves forward. Participants will receive 10 mL of placebo (saline) over 10 minutes while asleep during their first overnight visit. Participants will receive 0.2 mg oral clonidine and either 2 mg of IV psilocybin or saline over 10 minutes while asleep during their second overnight visit. Receives: Drug: Psilocybin; Drug: Clonidine; Other: Saline |
| Group 2B: 10-minute IV Psilocybin+Clonidine in Awake Participants | Experimental | If Group 2A participants can sleep 1 hour post-dosing and/or have no memory of dosing, Group 2B moves forward and participants will receive 0.2 mg clonidine and 2 mg of IV psilocybin over 10 minutes while awake. Receives: Drug: Psilocybin; Drug: Clonidine |
| Group 1C: 2-minute IV Psilocybin Alone in Awake Participants | Active comparator | If Group 1A allows for sleep 1 hour post dose, Group 1C will move forward and participants will receive 2mg of IV psilocybin over 2 minutes while awake for comparison. Receives: Drug: Psilocybin |
| Group 2C: 10-minute IV Psilocybin Alone in Awake Participants | Active comparator | If Group 2A allows for sleep 1 hour post dose, Group 2C will move forward and participants will receive 2mg of IV psilocybin over 10 minutes while awake for comparison. Receives: Drug: Psilocybin |
| Initial Groups 1A and 2A | Experimental | Participants will receive 2mg of IV psilocybin over 2 minutes or 10 minutes while asleep during an overnight visit and 10 mL of placebo (saline) over 2 minutes or 10 minutes while asleep during another overnight visit. The order of administration will be determined by the study protocol. Receives: Drug: Psilocybin; Other: Saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number and nature of adverse events associated with the administration of a single dose of IV psilocybin
Adverse events associated with the administration of a single dose of IV psilocybin administered either alone or in combination with oral clonidine in asleep and awake participants. Adverse event grading will be done using Common Terminology Criteria for Adverse Event (CTCAE)Adverse events will be graded from Grade 1-5 depending on severity. Grade 1 - mild, grade 2 - moderate, grade 3 - severe, grade 4 - Life threatening, grade 5 - Fatal. Adverse events will be collected on an Adverse Event Log throughout the study.
Measured: Up to 9 days
Secondary outcomes (10)
Number of participants administered psilocybin plus clonidine while asleep who remain asleep for at least 1 hour post dosing and/or report no memory of the dosing experience upon awakening
Measured: 1 day
Post-dosing scores on the 30-item Mystical Experiences Questionnaire (MEQ30) following administration of psilocybin and clonidine while asleep or awake
The MEQ30 is a 30-item self-report measure developed to assess the effects of classic psychedelics in laboratory studies. It covers the major dimensions of the classic mystical experience: unity, transcendence, noetic quality, sacredness, positive mood, and ineffability/paradoxicality. The MEQ has 4 sub scales: 1) transcendence, 2) positive mood, 3) ineffability, and 4) mystical. The total possible range for each sub scale and total score is 0-100% with higher percentages indicating a larger mystical experience. Typically, a complete mystical experience is defined as scoring 60% or more on all four MEQ30 subscales.
Measured: 1 day
Post-dosing scores on the Emotional Breakthrough Inventory (EBI) following administration of IV psilocybin either alone or in combination with clonidine while awake
The EBI is a 6-item self-report scale that assesses the presence and severity of emotionally challenging/distressing experiences that occur during a psychedelic experience. The scale utilizes visual analog responses captured on a line anchored by "not at all" on one end and "very much so" on the other. Experiences queried include 1) facing emotionally difficult feelings that are usually pushed aside; 2) experiencing a resolution of a personal conflict/trauma; 3) being able to explore challenging emotions and memories; 4) having an emotional breakthrough; 5) getting a sense of closure on an emotional problem, and 6) achieving an emotional release followed by a sense of relief. The total possible range of scores for the EBI is 0-100 with higher scores indicating a greater emotional breakthrough.
Measured: 1 day
Post-dosing scores on the Psychological Insight Scale (PIS) following administration of IV psilocybin either alone or in combination with clonidine while awake
The PIS is a 6-item self-report scale that queries the acquisition of insight following a psychedelic therapy. The items are answered with visual analogue scales anchored by "no more than usually" on the left and "much more than usually" on the far right. A seventh item separately assesses self-reported behavioral change resulting from the psychedelic experience. The total possible range of scores for the PIS is 0-100 with higher scores indicating a greater psychological insight.
Measured: 1 day
Post-dosing scores on the Ego Dissolution Inventory (EDI) following administration of IV psilocybin either alone or in combination with clonidine while awake
The EDI is an 8-item self-report scale designed to measure ego-dissolution. Each item is scored on a visual analogue scale from 0 to 100 with the following statements at the lower and upper end, respectively: "No, not more than usually" and "Yes, I experienced this completely/entirely." The total possible range of scores for the EDI is 0-100 with higher scores indicating a greater ego dissolution.
Measured: 1 day
Post-dosing scores on the Awe Experiences Scale (AWE) following administration of IV psilocybin either alone or in combination with clonidine while awake
The AWE is a 30-item self-report scale that measures the state of awe. Each items is rated on a scale of 1 to 7, with 1 representing "Strongly Disagree" and 7 representing "Strongly Agree". The total possible range of scores for the AWE is 1-7 with higher scores indicating a greater awe.
Measured: 1 day
Post-dosing scores on the Altered States of Consciousness Questionnaire (ASC) following administration of IV psilocybin while either alone or in combination with clonidine while awake
The ASC is a 94-item self-report scale that assesses alterations from your normal waking consciousness. Each item is scored on a visual analogue scale from 0 to 100 with the following statements at the lower and upper end, respectively: "No, not more than usually" and "Yes, much more than usually." The total possible range of scores for the ASC is 0-100 with higher scores indicating a greater state of altered consciousness.
Measured: 1 day
Post-dosing scores on the Challenging Experiences Questionnaire (CEQ) following administration of IV psilocybin either alone or in combination with clonidine while awake
The CEQ is a 26-item questionnaire that consists of seven factors of challenging experience with psilocybin mushrooms: fear, grief, feeling of losing your sanity (insanity), feel as though you are dying (death), feelings of isolation, physiological distress, and paranoia. The CEQ uses a 6-point response scale [0: None/not at all, 1: So slight cannot decide, 2: Slight, 3: Moderate, 4: Strong; 5: Extreme (more than ever before in my life)] to indicate the degree to which a participant experiences each of a series of subjective effects during their psilocybin session. Total CEQ score is expressed as the percentage of the total possible ratings on the scale. The total possible range of scores for the CEQ is 0-5 with higher scores indicating a greater challenging experience.
Measured: 1 day
Warwick-Edinburgh Mental Well-Being Scale (WEMWBS) score 7 days post administration of IV psilocybin either alone or in combination with clonidine while awake
The WEMWBS is a 14-item self-report scale that was designed to measure the psychological well-being of a population. The questions use a five-point Likert scale. The items are all worded positively and cover both feeling and functioning aspects of mental wellbeing. Items on the questionnaire are rated on a 5-point scale, where 1= "None of the time", 2= "rarely", 3= "some of the time", 4= "often", 5= "all the time". A total scale score is calculated by summing the 14 individual item scores. The total possible range of scores for the WEMWBS is 14-70 with higher scores indicating a greater well-being.
Measured: Up to 19 days
World Health Organization Well-Being Index
World Health Organization Well-Being Index (WHO-5) is a 5-item survey with a total possible range of scores 0-25 where higher scores indicate increased well-being.
Measured: Up to 19 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Oct 2022
- Study start7 Nov 2023
- Primary completion19 Feb 2025
- Study completion19 Feb 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- 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
- Non-randomised
- Intervention model
- Sequential
- Model description
- placebo first followed by placebo+clonidine or psilocybin+clonidine in asleep healthy volunteers
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Wisconsin, Madison
- Sponsor type
- University, hospital or other
- Collaborators
- Usona Institute, Tiny Blue Dot Foundation
- Responsible party
- Sponsor
- Investigators
- Charles Raison, MD, Principal investigator, University of Wisconsin, Madison
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05592379
- Sponsor's protocol ID
- 2022-0746
- Other IDs
- A532017, Protocol Version 10/2/2024, 233897
- Acronym
- CoPE Pilot
- Status last verified
- May 2025
- First submitted
- 19 Oct 2022
- Last updated
- 16 May 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: IDP will not be made available to other researchers.
Study at a glance
From the registry record, last updated by the sponsor on 16 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Consciousness and Psilocybin Effects on Well-Being (The CoPE Study): Pilot Phase
- ClinicalTrials.gov ID
- NCT05592379
- Acronym / sponsor ID
- CoPE Pilot / 2022-0746
- Conditions
- Healthy, Psychedelic Experiences, Sleep
- Keywords
- Sleep, Psilocybin, Psychedelics, Healthy Volunteer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 6 participants (actual)
- Lead sponsor
- University of Wisconsin, MadisonUniversity, hospital or other
- Collaborators
- Usona Institute, Tiny Blue Dot Foundation
- Study start
- 7 Nov 2023 (actual)
- Primary completion
- 19 Feb 2025 (actual)
- Study completion
- 19 Feb 2025 (actual)
- First posted
- 24 Oct 2022 (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 being done to identify a dosing strategy that will allow IV psilocybin to be administered to sleeping participants without awakening them.
Detailed description
The study commenced with 1 subject receiving 2 mg IV infusion of psilocybin over 2 minutes and 2 subjects receiving 2 mg IV infusion of psilocybin over 10 minutes. Subsequently, the pre-treatment of 0.2 mg of clonidine was added.
This design involves testing up to two psilocybin+clonidine administration protocols in asleep and awake subjects and one of two "IV psilocybin only" administration protocols in awake subjects.
The updated protocol entails 2 mg of psilocybin administered via IV infusion combined with 0.2 mg oral clonidine in sleeping subjects. If either the 2-minute or 10-minute psilocybin infusion (plus oral clonidine) protocols allow sleep maintenance, up to 5 subjects will, while awake, receive the same psilocybin infusion protocol administered to sleeping subjects, including clonidine. Subsequently, this same infusion protocol may be administered without clonidine, to evaluate any potential effect of co-administered clonidine on the acute psychedelic experience in awake subjects (Group 1C for 2-minute psilocybin infusion; Group 2C for 10-minute psilocybin infusion), should a significant effect of clonidine on the awake psychedelic experience be suspected. For individual subjects that are dosed first while asleep and then up to twice while awake, each of their visits will be separated by a minimum of two weeks and will include psychosocial support through integration sessions following each dosing visit.
Adaptive Study Design Change per Protocol Amendment Approved 5/21/24
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- Single blind (participant)
- Number of arms
- 7
- Model description
- placebo first followed by placebo+clonidine or psilocybin+clonidine in asleep healthy volunteers
| Arm | Type | Receives |
|---|---|---|
| Group 1A: 2-minute IV Psilocybin+Clonidine / Saline in Asleep Participants | Experimental | Drug: Psilocybin, Drug: Clonidine, Other: SalineParticipants will receive 10 mL of placebo (saline) over 2 minutes while asleep during their first overnight visit. Participants will receive 0.2 mg oral clonidine and either 2 mg of IV psilocybin or saline over 2 minutes while asleep during their second overnight visit. |
| Group 1B: 2-minute IV Psilocybin+Clonidine Infusion in Awake Participants | Experimental | Drug: Psilocybin, Drug: ClonidineIf Group 1A participants can sleep 1 hour post-dosing and/or have no memory of dosing, Group 1B moves forward and participants will receive 0.2 mg clonidine and 2 mg of IV psilocybin over 2 minutes while awake. |
| Group 2A: 2-minute IV Psilocybin+Clonidine / Saline in Asleep Participants | Experimental | Drug: Psilocybin, Drug: Clonidine, Other: SalineIf Group 1A participants fail to sleep 1 hour post-dose, Group 2A moves forward. Participants will receive 10 mL of placebo (saline) over 10 minutes while asleep during their first overnight visit. Participants will receive 0.2 mg oral clonidine and either 2 mg of IV psilocybin or saline over 10 minutes while asleep during their second overnight visit. |
| Group 2B: 10-minute IV Psilocybin+Clonidine in Awake Participants | Experimental | Drug: Psilocybin, Drug: ClonidineIf Group 2A participants can sleep 1 hour post-dosing and/or have no memory of dosing, Group 2B moves forward and participants will receive 0.2 mg clonidine and 2 mg of IV psilocybin over 10 minutes while awake. |
| Group 1C: 2-minute IV Psilocybin Alone in Awake Participants | Active comparator | Drug: PsilocybinIf Group 1A allows for sleep 1 hour post dose, Group 1C will move forward and participants will receive 2mg of IV psilocybin over 2 minutes while awake for comparison. |
| Group 2C: 10-minute IV Psilocybin Alone in Awake Participants | Active comparator | Drug: PsilocybinIf Group 2A allows for sleep 1 hour post dose, Group 2C will move forward and participants will receive 2mg of IV psilocybin over 10 minutes while awake for comparison. |
| Initial Groups 1A and 2A | Experimental | Drug: Psilocybin, Other: SalineParticipants will receive 2mg of IV psilocybin over 2 minutes or 10 minutes while asleep during an overnight visit and 10 mL of placebo (saline) over 2 minutes or 10 minutes while asleep during another overnight visit. The order of administration will be determined by the study protocol. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Medically healthy
- English-speaking
- Live within 150 miles of Madison, WI for duration of study
Key exclusion criteria (4 listed)
- Current use of medications that may interact with psilocybin
- Current sleep disorder, including (but not limited to) insomnia, sleep apnea, restless legs syndrome, and/or narcolepsy
- Females with positive urine pregnancy at any time point during screening or study participation
- Current cardiac valve disease
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: Psilocybine, PsilocibinThe IV formulation of psilocybin will be prepared using bulk psilocybin that will satisfy Good Manufacturing Practice (GMP) criteria. The IV psilocybin solution will be prepared under sterile conditions by the University of Wisconsin Pharmaceutical Research Center (PRC). | Drug | Group 1A: 2-minute IV Psilocybin+Clonidine / Saline in Asleep Participants, Group 1B: 2-minute IV Psilocybin+Clonidine Infusion in Awake Participants, Group 1C: 2-minute IV Psilocybin Alone in Awake Participants, Group 2A: 2-minute IV Psilocybin+Clonidine / Saline in Asleep Participants, Group 2B: 10-minute IV Psilocybin+Clonidine in Awake Participants, Group 2C: 10-minute IV Psilocybin Alone in Awake Participants, Initial Groups 1A and 2A |
| ClonidineClonidine will be administered orally in a 0.2mg dose | Drug | Group 1A: 2-minute IV Psilocybin+Clonidine / Saline in Asleep Participants, Group 1B: 2-minute IV Psilocybin+Clonidine Infusion in Awake Participants, Group 2A: 2-minute IV Psilocybin+Clonidine / Saline in Asleep Participants, Group 2B: 10-minute IV Psilocybin+Clonidine in Awake Participants |
| SalineAlso: PlaceboThe IV placebo (saline) will be prepared under sterile conditions by the University of Wisconsin Pharmaceutical Research Center. | Other | Group 1A: 2-minute IV Psilocybin+Clonidine / Saline in Asleep Participants, Group 2A: 2-minute IV Psilocybin+Clonidine / Saline in Asleep Participants, Initial Groups 1A and 2A |
Primary outcome
Number and nature of adverse events associated with the administration of a single dose of IV psilocybin
Time frame: Up to 9 days
Adverse events associated with the administration of a single dose of IV psilocybin administered either alone or in combination with oral clonidine in asleep and awake participants. Adverse event grading will be done using Common Terminology Criteria for Adverse Event (CTCAE)Adverse events will be graded from Grade 1-5 depending on severity. Grade 1 - mild, grade 2 - moderate, grade 3 - severe, grade 4 - Life threatening, grade 5 - Fatal. Adverse events will be collected on an Adverse Event Log throughout the study.
10 secondary outcomes
Number of participants administered psilocybin plus clonidine while asleep who remain asleep for at least 1 hour post dosing and/or report no memory of the dosing experience upon awakening
Time frame: 1 day
Post-dosing scores on the 30-item Mystical Experiences Questionnaire (MEQ30) following administration of psilocybin and clonidine while asleep or awake
Time frame: 1 day
Post-dosing scores on the Emotional Breakthrough Inventory (EBI) following administration of IV psilocybin either alone or in combination with clonidine while awake
Time frame: 1 day
Post-dosing scores on the Psychological Insight Scale (PIS) following administration of IV psilocybin either alone or in combination with clonidine while awake
Time frame: 1 day
Post-dosing scores on the Ego Dissolution Inventory (EDI) following administration of IV psilocybin either alone or in combination with clonidine while awake
Time frame: 1 day
Post-dosing scores on the Awe Experiences Scale (AWE) following administration of IV psilocybin either alone or in combination with clonidine while awake
Time frame: 1 day
Post-dosing scores on the Altered States of Consciousness Questionnaire (ASC) following administration of IV psilocybin while either alone or in combination with clonidine while awake
Time frame: 1 day
Post-dosing scores on the Challenging Experiences Questionnaire (CEQ) following administration of IV psilocybin either alone or in combination with clonidine while awake
Time frame: 1 day
Warwick-Edinburgh Mental Well-Being Scale (WEMWBS) score 7 days post administration of IV psilocybin either alone or in combination with clonidine while awake
Time frame: Up to 19 days
World Health Organization Well-Being Index
Time frame: Up to 19 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 May 2025.
- Individual participant dataSharing planned: No. IDP will not be made available to other researchers.
Related trials for Healthy
Not yet recruitingObservational study
Collection and Distribution of Blood Components From Healthy Donors for In Vitro Research Use
Blood Donors, Apheresis
Not yet recruitingPhase 1
Dynamic Magnetic Resonance Imaging of Human Subarachnoid Space Using Intrathecal Gadolinium Contrast
Healthy Volunteers
Enrolling by invitationObservational study
Connors Protocol for the Management and Use of Stored Human Specimens (Stored Human Specimens)
Healthy Volunteer Samples
RecruitingObservational study
Viral Infections in Healthy and Immunocompromised Hosts
Anogenital Herpes, COVID-19
RecruitingPhase 1
A Study in Healthy People to Compare How 2 Different Formulations of Vicadrostat / Empagliflozin Tablets Are Taken up in the Body
Healthy
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. This study is not recruiting at the moment.
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, Clonidine and Saline in people with Healthy 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 3 inclusion and 4 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: finished, as of the sponsor's last update on 16 May 2025. 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. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number and nature of adverse events associated with the administration of a single dose of IV psilocybin (time frame: Up to 9 days). 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 16 May 2025.