RECRUITING

The RECAP2 Study: Midazolam and Psilocybin

Description

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

Study Overview

Study Details

Study overview

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

Role of Experience, Conscious Awareness, and Plasticity in Psilocybin's Behavioral Effects - Follow-Up Study (The RECAP 2 Study)

The RECAP2 Study: Midazolam and Psilocybin

Condition
Psilocybin
Intervention / Treatment

-

Contacts and Locations

Madison

UW School of Medicine and Public Health, Madison, Wisconsin, United States, 53792

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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)
  • * 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

Ages Eligible for Study

18 Years to 65 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

Yes

Collaborators and Investigators

University of Wisconsin, Madison,

Charles Raison, MD, PRINCIPAL_INVESTIGATOR, University of Wisconsin, Madison

Study Record Dates

2027-11