Phase 1: testing Psilocybin for Healthy
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.
Official registry: https://clinicaltrials.gov/study/NCT05866471 · University of Wisconsin, Madison · enrollment listed as 115
What this phase means
Phase 1: the first tests in people. The main question is safety and dose, not whether it cures the condition. Groups are small. Side effects are watched closely.
Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.
What the registry says happens
If you join, the listed intervention(s) are Psilocybin, Transcutaneous auricular Vagus Nerve Stimulation (taVNS), or Psychosocial Support Alone. The registry lists allocation as randomized. 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.
They plan to enroll about 115 people at Madison. Taking part typically means taking a study drug (or dummy pill), using or being fitted with a device, following a program (exercise, therapy, diet, or an app) plus check-ins.
Official title (unrewritten)
Activating Neuroplasticity to ENHANCE the Perception Box Expanding Effects of Psilocybin
Interventions: Psilocybin, Transcutaneous auricular Vagus Nerve Stimulation (taVNS), Psychosocial Support Alone, Sham taVNS
Primary outcome (registry wording): Memory Experiences Questionnaire (MEM-Q-PSIL): Comparison of taVNS Administration vs. Treatment as Usual
Who it is for (from inclusion criteria)
- Ages 18 Years to 70 Years
- 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)
Who the registry excludes
- 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
- Use of psychedelic or related agents within three months of Dosing Day
- Clinically significant electrocardiogram (ECG)
- Vitals outside acceptable range
Public study contact (from the registry)
Program Manager
Published on ClinicalTrials.gov. Contact them as a possible participant. They decide eligibility.
Sites listed on ClinicalTrials.gov
1 listed- University of Wisconsin - Madison — Madison, Wisconsin (recruiting)
FAQ about this NCT record
Is NCT05866471 still recruiting?
The sponsor posted status “Recruiting” on ClinicalTrials.gov at last ingest. Sites can pause independently. Confirm with the official record and the listed contact.
What phase is NCT05866471?
Phase 1. Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.
Can PlainTrials tell me if I qualify for NCT05866471?
No. The inclusion and exclusion lists on this page are readable extracts of the public eligibility block. Only the study team can screen you.
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