RECRUITING

The ENHANCE Study: TaVNS 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

This study will examine whether combining a single dose of psilocybin with non-invasive transcutaneous auricular vagus nerve stimulation (taVNS), a potential inducer of neuroplasticity and enhanced memory formation, will enhance the long-term beneficial behavioral effects of psilocybin when compared to sham taVNS or no VNS by allowing memory for insights gained during the psychedelic experience to remain vivid after they will have faded in subjects who receive psilocybin followed by sham taVNS or no VNS.

Official Title

Activating Neuroplasticity to ENHANCE the Perception Box Expanding Effects of Psilocybin

Quick Facts

Study Start:2025-01
Study Completion:2028-01
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05866471

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 70 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Yes
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * English speaking
  2. * Ability/willingness to complete all study activities
  3. * Modest reduction in emotional well-being
  4. * Medically healthy (does not meet criteria for an exclusionary medical condition)
  5. * Blood pressure and heart rate within established ranges at screening
  6. * Use of acceptable contraceptive methods (sexually active males and women of childbearing potential)
  1. * Clinically significant safety lab abnormalities (i.e., Complete Blood Count with Differential, Comprehensive Metabolic Panel, and urinalysis)
  2. * Current exclusionary medical illness or Diagnostic and Statistical Manual (DSM-5) psychiatric diagnosis
  3. * Current use of drugs or medications, prescribed or otherwise, that may interact with psilocybin
  4. * Use of investigational drugs, biologics, or devices within 30 days of enrollment
  5. * Use of psychedelic or related agents within three months of screening
  6. * Clinically significant electrocardiogram (ECG)
  7. * Hypertension or tachycardia
  8. * Pregnancy and currently breastfeeding
  9. * Unwillingness to go without tobacco products for 12 hours or more
  10. * Inability to undergo fMRI scanning
  11. * Recent ear trauma, hearing loss, deafness, or colorblindness

Contacts and Locations

Study Contact

Program Manager
CONTACT
608-265-4987
enhance@psychiatry.wisc.edu

Principal Investigator

Charles Raison, MD
PRINCIPAL_INVESTIGATOR
University of Wisconsin, Madison

Study Locations (Sites)

University of Wisconsin - Madison
Madison, Wisconsin, 53715
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 Date2025-01
Study Completion Date2028-01

Study Record Updates

Study Start Date2025-01
Study Completion Date2028-01

Terms related to this study

Keywords Provided by Researchers

  • Psilocybin
  • Psychedelics
  • Vagus Nerve Stimulation
  • Healthy Volunteer

Additional Relevant MeSH Terms

  • Healthy
  • Psychedelic Experiences
  • Vagus Nerve Stimulation