The ENHANCE Study: Psilocybin and Vagus Nerve Stimulation
This study, called the ENHANCE Study, is looking at whether combining a single dose of psilocybin (a psychedelic compound) with transcutaneous auricular Vagus Nerve Stimulation (taVNS), a gentle electrical stimulation applied to the ear, can improve well-being. Researchers want to see if this combination helps people remember positive insights from their psychedelic experience for longer. You might be eligible if you are a healthy adult between 18 and 70 years old, speak English, and have a modest reduction in your emotional well-being. The study will measure success by looking at your memory of the experience, brain activity using fMRI (functional Magnetic Resonance Imaging), and overall mental well-being after 8 weeks. The current status of this study is unclear.
- Study design
- This interventional study plans to enroll 108 healthy adult volunteers. Participants will be randomized into one of four groups, receiving different combinations of active or sham taVNS before and after a single open-label 25 mg dose of psilocybin.
- What's involved
- You would receive a single 25 mg dose of psilocybin with psychological support. You would also use a taVNS device at home twice daily for 20 minutes for 7 consecutive days, either before or after psilocybin dosing. There will be preparation and integration sessions, and assessments at Day 1, Day 56, and 8 weeks post-psilocybin dose.
- Compensation
- Not stated in the trial record.
- Follow-up
- Your memory experiences and mental well-being will be assessed at 8 weeks. Functional MRI will be conducted at Day 1 and Day 56 after the psilocybin dose.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
The ENHANCE Study: taVNS and Psilocybin
At a glance
Conditions
Where it's being run
1 sites across 1 statesStudy leadership
- Charles Raison, MD · PRINCIPAL_INVESTIGATOR · University of Wisconsin, Madison
Who to contact
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Do you actually qualify for this trial?
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Inclusion
Exclusion
What this trial measures
- Memory Experiences Questionnaire (MEM-Q-PSIL): Comparison of taVNS Administration vs. Treatment as Usual8 weeks
The MEM-Q is 31-item self-report scales designed to measure 10 phenomenological qualities of autobiographical memories: Vividness, Coherence, Accessibility, Time Perspective, Sensory Details, Visual Perspective, Emotional Intensity, Sharing, Distancing and Valence. Ratings are made on a 5-point Likert scale, ranging from 1 (strongly disagree) to 5 (strongly agree).
- Functional Magnetic Resonance Imaging (fMRI): Comparison of taVNS Administration vs. Treatment as UsualDay 1 and Day 56 Post- Psilocybin Dose
Activation in brain regions associated with cued autobiographical memory retrieval will be assessed with fMRI. Group comparisons will examine differences in whole brain blood oxygenated level dependent (BOLD) signal and connectivity based on previously established seed-based methods using a priori brain regions implicated in autobiographical memory retrieval corresponding dosing session stimuli. The study team will update with more specific information when the details are confirmed.
- Warwick-Edinburgh Mental Wellbeing Scale (WEMWBS): Comparison of taVNS Administration vs. Treatment as Usual8 weeks
The WEMWBS is a 14-item self-report scale that was designed to measure the psychological well-being of a population. The questions use a five-point Likert scale. The items are all worded positively and cover both feeling and functioning aspects of mental wellbeing. Items on the questionnaire are rated on a 5-point scale, where 1= "None of the time", 2= "rarely", 3= "some of the time", 4= "often", 5= "all the time". A total scale score is calculated by summing the 14 individual item scores. The total possible range of scores for the WEMWBS is 14-70 with higher scores indicating a greater well-being.
- Summary of Adverse Eventsup to 8 weeks
Adverse events (AEs) categorized by CTCAE v5.0 criteria at all assessments (6 study visits).