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The ENHANCE Study: taVNS and Psilocybin

University of Wisconsin, Madison · with Tiny Blue Dot Foundation, Advanced Research Projects Agency for Health (ARPA-H) · NCT05866471

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Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.

Key facts

Compensation
Not posted. Ask the study team before screening.
Who can join
Ages 18–70 · All sexes
Healthy volunteers
Accepted
Study type
Interventional · Phase 1
Target enrollment
115
US sites recruiting
1
Study start
January 27, 2025
Record last updated
October 20, 2026

Status re-checked against ClinicalTrials.gov within the last 12 hours.

What the study 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.

Being studied: Psilocybin; Transcutaneous auricular Vagus Nerve Stimulation (taVNS); Psychosocial Support Alone; Sham taVNS

Conditions: Healthy; Psychedelic Experiences; Vagus Nerve Stimulation

Eligibility criteria

Copied from the official record. The study team makes the final decision at screening.

Show full criteria

Inclusion 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)

Exclusion Criteria

  • 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

Recruiting US locations

  • University of Wisconsin - Madison

    Madison, WI 53715

    Site contact: Program Manager · enhance@psychiatry.wisc.edu

Study contacts (from the official record)

  • Program Manager · 608-265-4987 · enhance@psychiatry.wisc.edu
All healthy volunteers studies in Wisconsin →
The ENHANCE Study: taVNS and Psilocybin (NCT05866471) | Bored Studies