RecruitingPhase 1psilocybin

The ENHANCE Study: taVNS and Psilocybin

NCT ID

NCT05866471

Target Enrollment

108 participants

Start Date

2025-01-27

Est. Completion

2028-01

About This Study

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.

Conditions Studied

HealthyPsychedelic ExperiencesVagus Nerve Stimulation

Interventions

•Psilocybin
•Transcutaneous auricular Vagus Nerve Stimulation (taVNS)
•Psychosocial Support Alone
•Sham taVNS

Eligibility

Age:18 Years - 70 Years

Healthy Volunteers:Yes

View full 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

Study Locations (1)

University of Wisconsin - Madison