Activating Neuroplasticity to ENHANCE the Perception Box Expanding Effects of Psilocybin
University of Wisconsin, Madison
Summary
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.
Description
One hundred and eight medically healthy adult volunteers with a modest decrement in wellbeing will receive a single open-label 25 mg dose of psilocybin administered within a "set and setting" (SaS) framework of psychological support provided by trained facilitators, such as has been successfully employed in prior psychedelic studies at UW-Madison. The SaS protocol will include 2-4 hours of preparation, a 6- to 8-hour psilocybin dosing session and an hour-long integration session 1 day and 9 days post dosing. All subjects will receive various combinations of active taVNS or sham taVNS prior to,…
Eligibility
- Age range
- 18–70 years
- Sex
- All
- Healthy volunteers
- Yes
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 psyc…
Interventions
- DrugPsilocybin
The psilocybin is produced under Good Manufacturing Practice and is in a capsule that contains 25 mg of botanically-derived psilocybin.
- DeviceTranscutaneous auricular Vagus Nerve Stimulation (taVNS)
For both the active and sham taVNS procedure, participants will be provided with, and trained on, taVNS devices that apply gentle stimulation to the left ear via either electrodes or an earpiece that fits over the left ear.
- BehavioralPsychosocial Support Alone
Participants assigned to Psychosocial Support Alone will not receive taVNS following psilocybin dosing.
- OtherSham taVNS
For both the active and sham taVNS procedure, participants will be provided with, and trained on, taVNS devices that apply gentle stimulation to the left ear via either electrodes or an earpiece that fits over the left ear.
Location
- University of Wisconsin - MadisonMadison, Wisconsin