Actively Recruiting

Phase 1
Age: 18Years - 65Years
All Genders
Healthy Volunteers
NCT06692192

The RECAP2 Study: Midazolam and Psilocybin

Led by University of Wisconsin, Madison · Updated on 2026-04-03

60

Participants Needed

1

Research Sites

120 weeks

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

The goal of this clinical trial is to learn about the role that inducing neuroplasticity (the brain's ability to adapt and change) plays in the behavioral effects of psilocybin in people who have experienced a mild decline in emotional wellbeing. 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

CONDITIONS

Official Title

The RECAP2 Study: Midazolam and Psilocybin

Who Can Participate

Age: 18Years - 65Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 18 to 65 years at screening, of any identified gender and racial/ethnic group
  • 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)
Not Eligible

You will not qualify if you...

  • Exclusionary DSM-5 psychiatric diagnosis and/or active suicidal ideation
  • 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

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

UW School of Medicine and Public Health

Madison, Wisconsin, United States, 53792

Actively Recruiting

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Research Team

R

RECAP Study Contact

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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The RECAP2 Study: Midazolam and Psilocybin | DecenTrialz