Investigation to Understand and Optimize Psilocybin

Summary

This study will examine the effects of a single dose of psilocybin, administered with psychological support, on symptoms of depression. It will also assess whether different post-dosing interventions, including a non-invasive technique called transcutaneous auricular Vagus Nerve Stimulation (taVNS), influence various psychological and behavioral outcomes. In addition, the study will explore objective measures of real-world social behavior and identify early behavioral responses that may be associated with long-term treatment outcomes.

Conditions

• Depression

Interventions

DRUG

Psilocybin

The psilocybin used in this study is synthesized under Good Manufacturing Practice (GMP) guidelines and is provided in a capsule containing 25 mg of synthetic psilocybin.

DEVICE

Transcutaneous Auricular Vagus Nerve Stimulation (taVNS)

Participants will be provided with a taVNS device and trained on its use. The device delivers gentle stimulation to the left ear.

DEVICE

Sham taVNS

Participants will be provided with a taVNS device and trained on its use. The device delivers gentle stimulation to the left ear. In the sham condition, the device will simulate the sensations of active taVNS without delivering therapeutic stimulation.

Sponsors & Collaborators

• Usona Institute

  collaborator OTHER

• Tiny Blue Dot Foundation

  collaborator OTHER

• Steadman Philippon Research Institute

  collaborator OTHER

• Emory University

  collaborator OTHER

• Charles Raison

  lead OTHER

Principal Investigators

• Charles Raison, MD · Vail Health Behavioral Health

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

70 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2025-05-13

Primary Completion

2029-05-31

Completion

2029-05-31

FDA Drug

Yes

FDA Device

Yes

Countries

• United States

Study Locations