RecruitingPhase 1psilocybin

The RECAP2 Study: Midazolam and Psilocybin

NCT ID

NCT06692192

Target Enrollment

60 participants

Start Date

2025-08-07

Est. Completion

2027-12

About This Study

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

Conditions Studied

Psilocybin

Interventions

•Psilocybin
•Psilocybin
•Midazolam
•Saline

Eligibility

Age:18 Years - 65 Years

Healthy Volunteers:Yes

View full 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

Study Locations (1)

UW School of Medicine and Public Health