RECRUITING

The RECAP2 Study: Midazolam and Psilocybin

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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

Official Title

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

Quick Facts

Study Start:2025-07
Study Completion:2027-11
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06692192

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.

Ages Eligible for Study:18 Years to 65 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Yes
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Age 18 to 65 years at screening, of any identified gender and racial/ethnic group
  2. * Physically healthy; does not meet criteria for an exclusionary medical condition
  3. * English-speaking (able to provide consent and complete questionnaires)
  4. * Modest decrement in self-reported wellbeing without the presence of a DSM-5 Axis I mood or anxiety disorder
  5. * Able to undergo magnetic resonance imaging (MRI) and transcranial magnetic stimulation (TMS)
  1. * Exclusionary DSM-5 psychiatric diagnosis and/or active suicidal ideation
  2. * Exclusionary medical conditions
  3. * Clinically significant safety lab abnormalities (i.e., Complete Blood Count with Differential, Comprehensive Metabolic Panel, and urinalysis)
  4. * Clinically significant electrocardiogram (ECG)
  5. * Use of psychotropic or CNS-altering medications within 3 months of screening
  6. * Hypertension or tachycardia

Contacts and Locations

Study Contact

Laura McCormick
CONTACT
608-265-4987
raisonlab@psychiatry.wisc.edu

Principal Investigator

Charles Raison, MD
PRINCIPAL_INVESTIGATOR
University of Wisconsin, Madison

Study Locations (Sites)

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

Collaborators and Investigators

Sponsor: University of Wisconsin, Madison

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

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-07
Study Completion Date2027-11

Study Record Updates

Study Start Date2025-07
Study Completion Date2027-11

Terms related to this study

Keywords Provided by Researchers

  • sub-optimal wellbeing

Additional Relevant MeSH Terms

  • Psilocybin