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RecruitingPhase 1

The ENHANCE Study: taVNS and Psilocybin

NCT05866471 · ENHANCE · University of Wisconsin, Madison

Recruiting
Status
Accepting participants
Phase 1
Phase
108
Target enrolment
1
Study sites
1 US states

What it is testing

Summary

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.

Summary as written by the trial’s own sponsor and published on ClinicalTrials.gov API v2. It is the sponsor’s description, reproduced unedited, not an assessment by this site.

What counts as success

Primary outcome measures

  • Memory Experiences Questionnaire (MEM-Q-PSIL): Comparison of taVNS Administration vs. Treatment as Usual

    Measured over 8 weeks

  • Functional Magnetic Resonance Imaging (fMRI): Comparison of taVNS Administration vs. Treatment as Usual

    Measured over Day 1 and Day 56 Post- Psilocybin Dose

  • Warwick-Edinburgh Mental Wellbeing Scale (WEMWBS): Comparison of taVNS Administration vs. Treatment as Usual

    Measured over 8 weeks

  • Summary of Adverse Events

    Measured over up to 8 weeks

A trial succeeds or fails on its primary outcome, declared in advance. Everything else it reports is secondary by definition.

Who can take part

Eligibility, as published

18 Years to 70 Years
Ages
All
Sex
Accepted
Healthy volunteers
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

Where

1 study site

FacilityCityRegionCountry
University of Wisconsin - MadisonMadisonWisconsinUnited States

On the registry

Contact the trial directly

This site does not enrol anyone and is not involved in this trial. To ask about taking part, use the sponsor’s own contact details on the official registry record, which is also where the most current version of everything above lives.

Before you do, the preparation checklist lists what a site will ask you on a first call and what is worth asking them. It is free and collects nothing.

NCT05866471 on ClinicalTrials.gov →

Last updated in the registry 2026-07-29. Registry records change; this page reflects the data build of 2026-08-25.

Related

Where this trial sits