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RECRUITING
NCT05866471
PHASE1

The ENHANCE Study: taVNS and Psilocybin

Sponsor: University of Wisconsin, Madison

View on ClinicalTrials.gov

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.

Official title: Activating Neuroplasticity to ENHANCE the Perception Box Expanding Effects of Psilocybin

Key Details

Gender

All

Age Range

18 Years - 70 Years

Study Type

INTERVENTIONAL

Enrollment

108

Start Date

2025-01-27

Completion Date

2028-01

Last Updated

2026-04-03

Healthy Volunteers

Yes

Interventions

DRUG

Psilocybin

The psilocybin is produced under Good Manufacturing Practice and is in a capsule that contains 25 mg of botanically-derived psilocybin.

DEVICE

Transcutaneous 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.

BEHAVIORAL

Psychosocial Support Alone

Participants assigned to Psychosocial Support Alone will not receive taVNS following psilocybin dosing.

OTHER

Sham 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