The ENHANCE Study: TaVNS and Psilocybin

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.

Conditions

Healthy, Psychedelic Experiences, Vagus Nerve Stimulation

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Study Overview

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Study Details

Study overview

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.

Activating Neuroplasticity to ENHANCE the Perception Box Expanding Effects of Psilocybin

The ENHANCE Study: TaVNS and Psilocybin

Condition
Healthy
Intervention / Treatment

-

Contacts and Locations

Madison

University of Wisconsin - Madison, Madison, Wisconsin, United States, 53715

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

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

Ages Eligible for Study

18 Years to 70 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

2028-01