Actively Recruiting
Role of Experience, Conscious Awareness, and Plasticity in Psilocybin's Behavioral Effects - Follow-Up Study (The RECAP 2 Study)
Led by University of Wisconsin, Madison ยท Updated on 2026-04-03
60
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
Sponsors
U
University of Wisconsin, Madison
Lead Sponsor
V
Vail Health Foundation
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are investigating how inducing neuroplasticity, which is the brain's ability to adapt and change, affects the behavioral impact of psilocybin in adults who have experienced a mild decline in emotional wellbeing. This Phase 1 study compares different doses of psilocybin combined with either midazolam or a placebo to understand which dose may increase wellbeing. Participants will be randomly assigned to one of four groups receiving either 25 mg or 1 mg of psilocybin combined with intravenous midazolam or saline placebo. Midazolam is used to induce amnesia of the psychedelic experience without over-sedation. During the study, participants will receive these medication combinations under controlled conditions. Throughout the trial, participants will undergo MRI scans, transcranial magnetic stimulation (TMS), and EEG assessments. They will complete questionnaires measuring wellbeing and psychological responses at baseline and up to 28 days after dosing. The primary outcomes include changes in mental wellbeing, experiential avoidance, learning tasks, and brain activity from baseline to 7 days post-dose. Safety and behavioral effects will be monitored, with the total participation lasting several weeks.
CONDITIONS
Brief Title
The RECAP2 Study: Midazolam and Psilocybin
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 to 65 years at screening, of any gender and racial/ethnic group
- Physically healthy without exclusionary medical conditions
- Able to speak English and complete consent and questionnaires
- Experienced a modest decline in self-reported wellbeing without a DSM-5 Axis I mood or anxiety disorder
- Able to undergo magnetic resonance imaging (MRI) and transcranial magnetic stimulation (TMS)
You will not qualify if you...
- Presence of exclusionary DSM-5 psychiatric diagnosis or active suicidal ideation
- Exclusionary medical conditions
- Clinically significant abnormalities in safety laboratory tests (Complete Blood Count, Metabolic Panel, urinalysis)
- Clinically significant electrocardiogram (ECG) abnormalities
- Use of psychotropic or central nervous system-altering medications within 3 months before screening
- Hypertension or tachycardia
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 1 day
Participants receive psilocybin combined with either intravenous midazolam or saline as part of the study drug regimen.
1 dosing visit (in-person)
Duration - 28 days
Participants are monitored for changes in emotional wellbeing and other outcomes up to 28 days after dosing.
Weekly visits for up to 4 weeks
Trial Site Locations
Total: 1 location
1
UW School of Medicine and Public Health
Madison, Wisconsin, United States, 53792
Actively Recruiting
Research Team
R
RECAP Study Contact
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
BASIC_SCIENCE
Number of Arms
4
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