Investigation to Understand and Optimize Psilocybin

PHASE2RecruitingINTERVENTIONAL
Enrollment

141

Participants

Timeline

Start Date

May 13, 2025

Primary Completion Date

May 31, 2029

Study Completion Date

May 31, 2029

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.

Trial Locations (1)

81632

RECRUITING

Vail Health Behavioral Health, Edwards

All Listed Sponsors
collaborator

Usona Institute

OTHER

collaborator

Tiny Blue Dot Foundation

OTHER

collaborator

Steadman Philippon Research Institute

OTHER

collaborator

Emory University

OTHER

lead

Charles Raison

OTHER