RECRUITING Phase 1 ClinicalTrials.gov

The ENHANCE Study: taVNS and Psilocybin

Sponsor: University of Wisconsin, Madison • ClinicalTrials.gov ID: NCT05866471

Registry updated: 2026-10-20

Recruiting for Similar Conditions?

Sponsors are looking for patients like you. See if you qualify for compensated research studies.

Description

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.

Interventions

Psilocybin (Drug)
The psilocybin is produced under Good Manufacturing Practice and is in a capsule that contains 25 mg of botanically-derived psilocybin.
Transcutaneous auricular Vagus Nerve Stimulation (taVNS) (Device)
For both the active and sham taVNS procedure, participants will be provided with, and trained on, taVNS devices that apply gentle stimulation to the left ear via either electrodes or an earpiece that fits over the left ear.
Psychosocial Support Alone (Behavioral)
Participants assigned to Psychosocial Support Alone will not receive taVNS following psilocybin dosing.
Sham taVNS (Other)
For both the active and sham taVNS procedure, participants will be provided with, and trained on, taVNS devices that apply gentle stimulation to the left ear via either electrodes or an earpiece that fits over the left ear.

Eligibility 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

Conditions

Healthy Psychedelic Experiences Vagus Nerve Stimulation

Locations

University of Wisconsin - Madison — Madison, Wisconsin, United States

Partner with Nurenyx

Showcase your study to thousands of motivated patients matching your criteria.

Learn More

Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

View Official Record

Accelerate Your Clinical Trial Recruitment