The RECAP2 Study: Midazolam and Psilocybin
ConditionPsilocybin
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-65
SponsorUniversity of Wisconsin, Madison
About this trial
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
Eligibility criteria
Qualifiers
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
Disqualifiers
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)
Trial design
Treatments tested in this trial
- Psilocybin
- Psilocybin
- Midazolam
- Saline
Treatment groups
60 Participants
are divided into 4 treatment groupsSponsors and collaborators
University of Wisconsin, Madison
Lead sponsor
Vail Health Foundation
Collaborator
Source ClinicalTrials.gov