RecruitingPhase 1NCT05866471

The ENHANCE Study: taVNS and Psilocybin

Activating Neuroplasticity to ENHANCE the Perception Box Expanding Effects of Psilocybin


Sponsor

University of Wisconsin, Madison

Enrollment

108 participants

Start Date

Jan 27, 2025

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 YearsMax Age: 70 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called Psilocybin, a behavioral approach called Psychosocial Support Alone, and others for people with healthy, psychedelic experiences, and other related conditions. The study is currently recruiting participants at 1 location. People eligible for this study include aged 18 Years to 70 Years.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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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.


Locations(1)

University of Wisconsin - Madison

Madison, Wisconsin, United States

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NCT05866471


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