The ENHANCE Study: taVNS and Psilocybin

Launched by UNIVERSITY OF WISCONSIN, MADISON · May 10, 2023

Keywords

ClinConnect Summary

The ENHANCE Study is exploring a new approach to enhance the benefits of psilocybin, a psychedelic substance, by combining it with a technique called transcutaneous auricular vagus nerve stimulation (taVNS). This technique involves gentle stimulation of the vagus nerve in the ear, which may help improve memory and learning from the experiences during the psilocybin treatment. The goal is to see if this combination helps people retain the positive insights gained during the psychedelic experience better than those who do not receive the stimulation.

To participate in this study, you need to be between 18 and 65 years old, speak English, and be in good health, meaning you shouldn't have any serious medical conditions or current psychiatric diagnoses. You should also be willing to complete all study activities and have a mild reduction in emotional well-being. If you join, you will receive either the psilocybin treatment with taVNS or a placebo (a non-active treatment) and will be closely monitored throughout the process. It's important to note that certain health issues, recent use of specific drugs, or conditions like pregnancy may disqualify you from participating.

Gender

ALL

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 exclusionary medical illness or Diagnostic and Statistical Manual (DSM-5) psychiatric diagnosis
• • 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)
• • Hypertension or tachycardia
• • 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), deafness, or colorblindness
• • Family history of a psychotic disorder in a first degree relative