The ENHANCE Study: taVNS and Psilocybin

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.

Conditions

• Healthy
• Psychedelic Experiences
• Vagus Nerve Stimulation

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.

Sponsors & Collaborators

• Tiny Blue Dot Foundation

  collaborator OTHER

• University of Wisconsin, Madison

  lead OTHER

Principal Investigators

• Charles Raison, MD · University of Wisconsin, Madison

Study Design

Allocation

RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

TRIPLE

Model

FACTORIAL

Eligibility

Min Age

18 Years

Max Age

70 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2025-01-27

Primary Completion

2027-11-30

Completion

2028-01-31

FDA Drug

Yes

Countries

• United States

Study Locations