The RECAP2 Study: Midazolam and Psilocybin

Launched by UNIVERSITY OF WISCONSIN, MADISON · Nov 15, 2024

Keywords

ClinConnect Summary

The RECAP2 Study is a clinical trial designed to explore how a substance called psilocybin, when combined with a medication called midazolam, can improve emotional wellbeing in individuals who have experienced a slight decline in their mood. The researchers want to find out what dose of psilocybin works best for enhancing wellbeing by looking at how it affects the brain's ability to adapt and change.

To participate, individuals need to be between 18 and 70 years old, in good physical health, and able to speak English. They should have a modest decrease in their feeling of wellbeing but not have any major mood or anxiety disorders. Participants will receive one of four different combinations of medications and will undergo various assessments, including an MRI scan and questionnaires. It’s important to note that this trial is not yet recruiting, so interested individuals will need to wait for further announcements.

Gender

ALL

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