Combining psilocybin with vagus nerve stimulation for enhanced memory
Activating Neuroplasticity to ENHANCE the Perception Box Expanding Effects of Psilocybin
PHASE1 · University of Wisconsin, Madison · NCT05866471
This study is testing if combining a dose of psilocybin with a gentle nerve stimulation can help healthy adults with a slight drop in well-being improve their memory of insights gained during the experience.
Quick facts
| Phase | PHASE1 |
|---|---|
| Study type | Interventional |
| Enrollment | 108 (estimated) |
| Ages | 18 Years to 70 Years |
| Sex | All |
| Sponsor | University of Wisconsin, Madison (other) |
| Locations | 1 site (Madison, Wisconsin) |
| Trial ID | NCT05866471 on ClinicalTrials.gov |
What this trial studies
This study investigates the effects of combining a single dose of psilocybin with non-invasive transcutaneous auricular vagus nerve stimulation (taVNS) on healthy adult volunteers experiencing a modest decrease in well-being. Participants will receive a 25 mg dose of psilocybin along with various combinations of active or sham taVNS over a period of seven days. The study aims to determine if taVNS can enhance the long-term benefits of psilocybin by improving memory retention of insights gained during the psychedelic experience. Psychological support will be provided throughout the process to ensure a safe and supportive environment.
Who should consider this trial
Good fit: Ideal candidates are English-speaking, medically healthy adults with a modest reduction in emotional well-being.
Not a fit: Patients with significant medical or psychiatric conditions, or those currently using medications that may interact with psilocybin, may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to improved therapeutic outcomes for individuals seeking to enhance their emotional well-being through psychedelic experiences.
How similar studies have performed: While the combination of psilocybin and taVNS is a novel approach, previous studies have shown promising results with psilocybin in therapeutic settings.
Eligibility criteria
Show full inclusion / exclusion 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 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 * 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), or deafness * Family history of a psychotic disorder in a first degree relative
Where this trial is running
Madison, Wisconsin
- University of Wisconsin - Madison — Madison, Wisconsin, United States (RECRUITING)
Study contacts
- Principal investigator: Charles Raison, MD — University of Wisconsin, Madison
- Study coordinator: Program Manager
- Email: enhance@psychiatry.wisc.edu
- Phone: 608-265-4987
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Healthy, Psychedelic Experiences, Vagus Nerve Stimulation, Psilocybin, Psychedelics, Healthy Volunteer