Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE1
60 participants
INTERVENTIONAL
2025-08-07
2027-12-31
Brief Summary
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Researchers will compare different doses of psilocybin combined with midazolam or placebo to see what dose induces increased wellbeing.
Participants will:
* Receive one of four possible combinations of medications
* Undergo an MRI
* Complete questionnaires
* Undergo transcranial magnetic stimulation (TMS) and EEG
Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
BASIC_SCIENCE
TRIPLE
Study Groups
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Group 1: Psilocybin and intravenous (IV) midazolam
Psilocybin (25 mg) + IV midazolam
Psilocybin
25mg of psilocybin
Midazolam
The goal of the midazolam dosing regimen is to induce amnesia of the psychedelic experience without inducing over-sedation during the dosing session.
Group 2: Psilocybin and IV saline
Psilocybin (25 mg) + IV saline (placebo for midazolam)
Psilocybin
25mg of psilocybin
Saline
Saline will be administered as a placebo for midazolam
Group 3: Psilocybin and IV midazolam
Psilocybin (1 mg/control) + IV midazolam
Psilocybin
1mg of psilocybin
Midazolam
The goal of the midazolam dosing regimen is to induce amnesia of the psychedelic experience without inducing over-sedation during the dosing session.
Group 4: Psilocybin and IV saline
Psilocybin (1 mg/control) + IV saline
Psilocybin
1mg of psilocybin
Saline
Saline will be administered as a placebo for midazolam
Interventions
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Psilocybin
25mg of psilocybin
Psilocybin
1mg of psilocybin
Midazolam
The goal of the midazolam dosing regimen is to induce amnesia of the psychedelic experience without inducing over-sedation during the dosing session.
Saline
Saline will be administered as a placebo for midazolam
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Physically healthy; does not meet criteria for an exclusionary medical condition
* English-speaking (able to provide consent and complete questionnaires)
* Modest decrement in self-reported wellbeing without the presence of a DSM-5 Axis I mood or anxiety disorder
* Able to undergo magnetic resonance imaging (MRI) and transcranial magnetic stimulation (TMS)
Exclusion Criteria
* Exclusionary medical 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
18 Years
65 Years
ALL
Yes
Sponsors
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Vail Health Foundation
UNKNOWN
University of Wisconsin, Madison
OTHER
Responsible Party
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Principal Investigators
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Charles Raison, MD
Role: PRINCIPAL_INVESTIGATOR
University of Wisconsin, Madison
Locations
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UW School of Medicine and Public Health
Madison, Wisconsin, United States
Countries
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Central Contacts
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Other Identifiers
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A538900
Identifier Type: OTHER
Identifier Source: secondary_id
SMPH/PSYCHIATRY/PSYCHIATRY
Identifier Type: OTHER
Identifier Source: secondary_id
Protocol Version 10/23/2025
Identifier Type: OTHER
Identifier Source: secondary_id
2024-0852
Identifier Type: -
Identifier Source: org_study_id