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Recruiting NCT06692192

The RECAP2 Study: Midazolam and Psilocybin

Phase I Interventional Psilocybin

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Psilocybin, Psilocybin, Midazolam, Saline.
Who it may be relevant to
Registry conditions: Psilocybin. Basic parameters: 18 years — 65 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Role of Experience, Conscious Awareness, and Plasticity in Psilocybin's Behavioral Effects - Follow-Up Study (The RECAP 2 Study)

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

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.

Interventions

  • Drug Psilocybin
    25mg of psilocybin
  • Drug Psilocybin
    1mg of psilocybin
  • Drug Midazolam
    The goal of the midazolam dosing regimen is to induce amnesia of the psychedelic experience without inducing over-sedation during the dosing session.
  • Drug Saline
    Saline will be administered as a placebo for midazolam

Primary outcome measures

  • Change in Warwick-Edinburgh Mental wellbeing Scale (WEMWBS) [Time frame: Baseline to 7 days post-dose]
  • Change in Brief Experiential Avoidance Questionnaire (BEAQ) [Time frame: Baseline to 7 days post-dose]
  • Change in Probabilistic Reversal Learning (PRL) [Time frame: Baseline to 7 days post-dose]
  • Change in transcranial magnetic stimulation evoked potential (TEP) amplitude [Time frame: Baseline to 7 days post-dose]
Secondary outcome measures (7)
  • Change in WEMWBS [Time frame: Baseline to 28 days post-dose]
  • Change in BEAQ [Time frame: Baseline to 28 days post-dose]
  • Change in PRL [Time frame: Baseline to 28 days post-dose]
  • Change in TEP amplitude [Time frame: Baseline to 28 days post-dose]
  • Altered States of Consciousness (ASC) questionnaire [Time frame: Dosing 1 day]
  • Emotional Breakthrough Inventory (EBI) [Time frame: Dosing 1 day]
  • Psychological Insight Questionnaire (PIQ) [Time frame: Dosing 1 day]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Triple blind
Primary purpose
Basic science

Study locations

United States · 1 center
  • UW School of Medicine and Public Health — Madison

Identifiers

NCT: NCT06692192 · 2024-0852 · A538900 · SMPH/PSYCHIATRY/PSYCHIATRY · Protocol Version 12/12/2025

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗