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.
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NYU Langone HealthThis company doesn't have a full profile yet, it is linked to a clinical trial.