The ENHANCE Study: taVNS and Psilocybin

Recruiting now · Phase 1 · Has a placebo group

Conditions studied: Healthy, Psychedelic Experiences, Vagus Nerve Stimulation

In brief

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.

Key facts

Study ID

NCT05866471

Run by

University of Wisconsin, Madison

People needed

108

Starts

2025-01-27

Expected to finish

2028-01-01

Last updated by the study team

2026-07-29

Who can join

Age: 18 and older, up to 70. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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)

You may not qualify if…

• Clinically significant safety lab abnormalities (i.e., Complete Blood Count with Differential, Comprehensive Metabolic Panel, and urinalysis)
• Current or clinically significant psychiatric disorder that, in the investigator's judgment, would interfere with participation or increase risk
• 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 Dosing Day
• Clinically significant electrocardiogram (ECG)
• Vitals outside acceptable range
• 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 (if clinically significant), or deafness
• Family history of a psychotic disorder in a first degree relative

Where it is running

• University of Wisconsin - Madison — Madison, Wisconsin, United States (enrolling)

Full record on ClinicalTrials.gov

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