Actively Recruiting

Phase 1
Age: 18Years - 70Years
All Genders
Healthy Volunteers
NCT05866471

The ENHANCE Study: taVNS and Psilocybin

Led by University of Wisconsin, Madison · Updated on 2026-04-03

108

Participants Needed

1

Research Sites

152 weeks

Total Duration

On this page

Sponsors

U

University of Wisconsin, Madison

Lead Sponsor

T

Tiny Blue Dot Foundation

Collaborating Sponsor

AI-Summary

What this Trial Is About

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

Official Title

The ENHANCE Study: taVNS and Psilocybin

Who Can Participate

Age: 18Years - 70Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • English speaking
  • Ability and willingness to complete all study activities
  • Modest reduction in emotional well-being
  • Medically healthy without exclusionary medical conditions
  • Blood pressure and heart rate within established ranges at screening
  • Use of acceptable contraceptive methods if sexually active (males and women of childbearing potential)
Not Eligible

You will not qualify if you...

  • Clinically significant safety laboratory abnormalities
  • Current or significant psychiatric disorder that may interfere with participation or increase risk
  • Current use of drugs or medications that may interact with psilocybin
  • Use of investigational drugs, biologics, or devices within 30 days before enrollment
  • Use of psychedelic or related agents within 3 months before dosing day
  • Clinically significant abnormal electrocardiogram (ECG)
  • Vital signs outside acceptable range
  • Pregnancy or currently breastfeeding
  • Unwillingness to abstain from tobacco products for 12 hours or more
  • Inability to undergo fMRI scanning
  • Recent ear trauma, clinically significant hearing loss, or deafness
  • Family history of psychotic disorder in a first-degree relative

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

University of Wisconsin - Madison

Madison, Wisconsin, United States, 53715

Actively Recruiting

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Research Team

P

Program Manager

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

TRIPLE

Allocation

RANDOMIZED

Model

FACTORIAL

Primary Purpose

BASIC_SCIENCE

Number of Arms

4

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