NCT06760533View on ClinicalTrials.gov

Psilocybin-Assisted Psychotherapy in Treating Irritable Bowel Syndrome (IBS)

EARLY_PHASE1Not yet recruitingINTERVENTIONAL
Enrollment

10

Participants

Timeline

Start Date

August 31, 2025

Primary Completion Date

December 31, 2025

Study Completion Date

December 31, 2025

Conditions
IBS - Irritable Bowel Syndrome
Interventions
DRUG

Psilocybin 25 mg

Psilocybin 25 mg (active treatment) administered during the psychotherapy treatment session.

BEHAVIORAL

Psychotherapy Treatment Session

The psychotherapy treatment sessions will be conducted by two therapists, who will be both present for all the sessions during three phases of treatment: Preparation, Medication Administration, and Integration.

DRUG

Niacin 100 mg

Niacin 100 mg (placebo) administered during the psychotherapy treatment session.

Trial Locations (1)

10016

NYU Langone Health, New York

All Listed Sponsors
lead

NYU Langone Health

OTHER