Actively Recruiting
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
Eligibility Criteria
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)
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
Trial Site Locations
Total: 1 location
1
University of Wisconsin - Madison
Madison, Wisconsin, United States, 53715
Actively Recruiting
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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