The ENHANCE Study: taVNS and Psilocybin
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-70
SponsorUniversity of Wisconsin, Madison
About this trial
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
Qualifiers
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)
Disqualifiers
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
Trial design
Treatments tested in this trial
- Psilocybin
- Transcutaneous auricular Vagus Nerve Stimulation (taVNS)
- Psychosocial Support Alone
- Sham taVNS
Treatment groups
108 Participants
are divided into 4 treatment groupsSponsors and collaborators
University of Wisconsin, Madison
Lead sponsor
Tiny Blue Dot Foundation
Collaborator
Source ClinicalTrials.gov