Actively Recruiting
Activating Neuroplasticity to ENHANCE the Perception Box Expanding Effects of Psilocybin A Study of taVNS and Psilocybin in Healthy Adults
Led by University of Wisconsin, Madison · Updated on 2026-04-03
108
Participants Needed
1
Research Sites
8 weeks
Total Duration
On this page
Sponsors
U
University of Wisconsin, Madison
Lead Sponsor
T
Tiny Blue Dot Foundation
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating whether combining a single dose of psilocybin with non-invasive transcutaneous auricular vagus nerve stimulation (taVNS) can improve long-term behavioral benefits by helping memory for insights gained during the psychedelic experience stay vivid. This study involves medically healthy adults with a modest decrease in wellbeing and aims to compare active taVNS with sham taVNS or no stimulation following psilocybin dosing. Participants will receive a single 25 mg dose of psilocybin with psychological support lasting 2 to 4 hours before dosing and integration sessions 1 and 9 days after. They will be randomized into four groups to receive different combinations of active or sham taVNS before and after psilocybin dosing, or psychosocial support alone. The taVNS sessions last 20 minutes twice daily for seven days and are done at home. During the study, participants will undergo assessments including memory questionnaires, brain imaging with fMRI on dosing day and 56 days later, and mental wellbeing scales over 8 weeks. Researchers will monitor adverse events and compare the effects of taVNS administration versus usual treatment. The total participation involves preparation, dosing, multiple follow-up sessions, and safety monitoring lasting up to 8 weeks.
CONDITIONS
Brief Title
The ENHANCE Study: taVNS and Psilocybin
Who Can Participate
Eligibility Criteria
You may qualify if you...
- English speaking
- Ability and willingness to complete all study activities
- Modest reduction in emotional well-being
- Medically healthy without exclusionary medical conditions
- Blood pressure and heart rate within established ranges at screening
- Use of acceptable contraceptive methods for sexually active males and women of childbearing potential
You will not qualify if you...
- Clinically significant safety lab abnormalities
- Current or significant psychiatric disorder interfering with participation or increasing risk
- Use of drugs or medications that may interact with psilocybin
- Use of investigational drugs, biologics, or devices within 30 days prior to enrollment
- Use of psychedelic or related agents within three months before dosing
- Clinically significant electrocardiogram abnormalities
- Vital signs outside acceptable range
- Pregnancy or currently breastfeeding
- Unwillingness to abstain from tobacco for 12 or more hours
- Inability to undergo fMRI scanning
- Recent ear trauma, clinically significant hearing loss, or deafness
- Family history of psychotic disorder in a first degree relative
AI-Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 7 days
Participants receive twice daily active or sham taVNS sessions at home for 7 consecutive days prior to psilocybin dosing.
Twice daily sessions at home for 7 days
Duration - 3 days
Participants receive a single open-label 25 mg dose of psilocybin with psychological support including a 6- to 8-hour dosing session and preparation and integration sessions.
1 preparation session, 1 dosing session (6 to 8 hours), and 2 integration sessions (1 day and 9 days post dosing)
Duration - 7 days
Following psilocybin dosing, participants receive twice daily active or sham taVNS sessions at home for 7 consecutive days or psychosocial support alone depending on group assignment.
Twice daily sessions at home for 7 days or 2 integration sessions if receiving psychosocial support alone
Duration - Up to 8 weeks
Participants are monitored for outcomes including memory, mental wellbeing, and safety for up to 8 weeks after dosing.
Assessments including fMRI on Day 1 and Day 56 post dosing
Trial Site Locations
Total: 1 location
1
University of Wisconsin - Madison
Madison, Wisconsin, United States, 53715
Actively Recruiting
Research Team
P
Program Manager
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
FACTORIAL
Primary Purpose
BASIC_SCIENCE
Number of Arms
4
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