NCT06760533

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

Pilot Proof of Concept Study Evaluating the Potential Psilocybin Assisted Psychotherapy (PAP) as a Therapeutic Tool for Patients Suffering From Severe Irritable Bowel Syndrome.

• Status: Not Yet Recruiting
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 10 (estimated)
• Sponsor: NYU Langone Health · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This study will serve as a pilot randomized controlled trial to assess the feasibility of Psilocybin-Assisted Psychotherapy (PAP) in Treating Irritable Bowel Syndrome (IBS). Patients with severe IBS will undergo 3 pre-psychotherapy sessions with two licensed and trained psychedelic therapists, then will be randomized to undergo a guided psychotherapy session with single 25 mg oral "high" dose of psilocybin or a single 100 mg dose of niacin (active placebo) and attend 4 post-therapy integration sessions.

Conditions

• IBS - Irritable Bowel Syndrome

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2026-08-01
• Primary completion: 2026-12-01
• Completion: 2026-12-01
• First posted: 2025-01-07
• Last updated: 2026-03-05

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study