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

This triple-blind, placebo-controlled trial (n=10) will assess the feasibility of Psilocybin-Assisted Psychotherapy (PAP) in treating severe irritable bowel syndrome (IBS). Participants will receive a single 25 mg oral dose of psilocybin or a 100 mg dose of niacin (a placebo) during a guided psychotherapy session.

The study, conducted by NYU Langone Health, involves three preparatory therapy sessions before dosing and four integration therapy sessions afterward. It aims to evaluate whether psilocybin, combined with psychotherapy, can reduce IBS symptoms, particularly abdominal pain severity.

The primary outcome will be measured using the Abdominal Pain Severity Numeric Rating Scale (APS-NRS), while secondary outcomes include changes in IBS severity, anxiety, depression, and bowel habits. The trial is expected to run from January to December 2025.

Trial Details

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.

Trial Number NCT06760533

Data attribution

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