Healthy Clinical Trial
— ENHANCEOfficial title:
Activating Neuroplasticity to ENHANCE the Perception Box Expanding Effects of Psilocybin
This study will examine whether combining a single dose of psilocybin with non-invasive transcutaneous auricular vagus nerve stimulation (taVNS), a known inducer of neuroplasticity and enhanced memory formation, will enhance the long-term beneficial behavioral effects of psilocybin when compared to sham taVNS 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.
Status | Not yet recruiting |
Enrollment | 108 |
Est. completion date | October 2027 |
Est. primary completion date | July 2027 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 70 Years |
Eligibility | Inclusion Criteria: - English speaking - Ability/willingness to complete all study activities - Modest decrement 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 screening - 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, deafness, or colorblindness |
Country | Name | City | State |
---|---|---|---|
United States | University of Wisconsin - Madison | Madison | Wisconsin |
Lead Sponsor | Collaborator |
---|---|
University of Wisconsin, Madison | Tiny Blue Dot Foundation |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Memory Experiences Questionnaire (MEM-Q): Comparison of taVNS Administration vs. Treatment as Usual | The MEM-Q is a 63-item self-report scale 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). | 8 weeks | |
Primary | Functional Magnetic Resonance Imaging (fMRI): Comparison of taVNS Administration vs. Treatment as Usual | 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. | Day 1 and Day 56 Post- Psilocybin Dose | |
Primary | Warwick-Edinburgh Mental Wellbeing Scale (WEMWBS): Comparison of taVNS Administration vs. Treatment as Usual | 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. | 8 weeks | |
Primary | Summary of Adverse Events | Adverse events (AEs) categorized by CTCAE v5.0 criteria at all assessments (6 study visits). | up to 8 weeks |
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