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The RECAP2 Study: Midazolam and Psilocybin

The RECAP2 Study: Midazolam and Psilocybin

Recruiting
18-65 years
All
Phase 1

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Overview

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

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

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

Study details
    Psilocybin

NCT06692192

University of Wisconsin, Madison

15 October 2025

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FAQs

Learn more about clinical trials

What is a clinical trial?

A clinical trial is a study designed to test specific interventions or treatments' effectiveness and safety, paving the way for new, innovative healthcare solutions.

Why should I take part in a clinical trial?

Participating in a clinical trial provides early access to potentially effective treatments and directly contributes to the healthcare advancements that benefit us all.

How long does a clinical trial take place?

The duration of clinical trials varies. Some trials last weeks, some years, depending on the phase and intention of the trial.

Do I get compensated for taking part in clinical trials?

Compensation varies per trial. Some offer payment or reimbursement for time and travel, while others may not.

How safe are clinical trials?

Clinical trials follow strict ethical guidelines and protocols to safeguard participants' health. They are closely monitored and safety reviewed regularly.
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