RecruitingPhase 1

The RECAP2 Study: Midazolam and Psilocybin

United States60 participantsStarted 2025-08-07

Plain-language 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

Who can participate

Age range18 Years – 65 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

Change in Warwick-Edinburgh Mental wellbeing Scale (WEMWBS)

Timeframe: Baseline to 7 days post-dose

Change in Brief Experiential Avoidance Questionnaire (BEAQ)

Timeframe: Baseline to 7 days post-dose

Change in Probabilistic Reversal Learning (PRL)

Timeframe: Baseline to 7 days post-dose

Change in transcranial magnetic stimulation evoked potential (TEP) amplitude

Timeframe: Baseline to 7 days post-dose

Trial details

NCT IDNCT06692192

SponsorUniversity of Wisconsin, Madison

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2027-12

Contact for this trial

RECAP Study Contact

608-263-4852 recap2@psychiatry.wisc.edu

View on ClinicalTrials.gov More Psilocybin trials

Plain-language summary

Who can participate

Age range18 Years – 65 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Change in Warwick-Edinburgh Mental wellbeing Scale (WEMWBS)

Timeframe: Baseline to 7 days post-dose

Change in Brief Experiential Avoidance Questionnaire (BEAQ)

Timeframe: Baseline to 7 days post-dose

Change in Probabilistic Reversal Learning (PRL)

Timeframe: Baseline to 7 days post-dose

Change in transcranial magnetic stimulation evoked potential (TEP) amplitude

Timeframe: Baseline to 7 days post-dose