NCT06692192PHASE1RecruitingAccepts Healthy Volunteers

The RECAP2 Study: Midazolam and Psilocybin

University of Wisconsin, Madison

Start Date

8/7/2025

Completion Date

12/1/2027

Summary

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

Detailed Description

The purpose of this study is to investigate the role that inducing neuroplasticity plays in the behavioral effects of psilocybin in people with modest decrements in emotional wellbeing.

Eligibility Criteria

Age Range: 18 years to 65 years

Inclusion Criteria: * 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) Exclusion Criteria: * 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

Interventions

DRUG

Psilocybin

DRUG

Psilocybin

DRUG

Midazolam

DRUG

Saline

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Conditions

Psilocybin

Locations

UW School of Medicine and Public Health

Madison, Wisconsin 53792

United States