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 range

18 Years – 65 Years

Sex

ALL

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

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 range

18 Years – 65 Years

Sex

ALL

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