The RECAP2 Study: Midazolam and Psilocybin
Recruiting now · Phase 1 · Has a placebo group
Conditions studied: Psilocybin
In brief
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
Key facts
- Study ID
- NCT06692192
- Run by
- University of Wisconsin, Madison
- People needed
- 60
- Starts
- 2025-08-07
- Expected to finish
- 2027-12-01
- Last updated by the study team
- 2026-04-03
Who can join
Age: 18 and older, up to 65. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- 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)
You may not qualify if…
- 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
Where it is running
- UW School of Medicine and Public Health — Madison, Wisconsin, United States (enrolling)
Full record on ClinicalTrials.gov
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