NCT05866471 The ENHANCE Study: taVNS and Psilocybin
| NCT ID | NCT05866471 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | University of Wisconsin, Madison |
| Condition | Healthy |
| Study Type | INTERVENTIONAL |
| Enrollment | 108 participants |
| Start Date | 2025-01-27 |
| Primary Completion | 2027-11 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 108 participants in total. It began in 2025-01-27 with a primary completion date of 2027-11.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
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
Contact & Investigator
Charles Raison, MD
PRINCIPAL INVESTIGATOR
University of Wisconsin, Madison
Frequently Asked Questions
Who can join the NCT05866471 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 70 Years, studying Healthy. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05866471 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT05866471 currently recruiting?
Yes, NCT05866471 is actively recruiting participants. Contact the research team at enhance@psychiatry.wisc.edu for enrollment information.
Where is the NCT05866471 trial being conducted?
This trial is being conducted at Madison, United States.
Who is sponsoring the NCT05866471 clinical trial?
NCT05866471 is sponsored by University of Wisconsin, Madison. The principal investigator is Charles Raison, MD at University of Wisconsin, Madison. The trial plans to enroll 108 participants.