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

Starting soon · Early Phase 1 · Has a placebo group

Conditions studied: IBS - Irritable Bowel Syndrome

In brief

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.

Key facts

Study ID

NCT06760533

Run by

NYU Langone Health

People needed

10

Starts

2026-08-01

Expected to finish

2026-12-01

Last updated by the study team

2026-03-05

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Severe IBS patients meeting Rome IV criteria. Severe IBS is defined by IBS-SS >300, or one or more emergency room (ER) visit for abdominal pain in the last year.
• Experiencing persistent IBS symptoms despite pharmacologic therapy
• Have an identified support person
• Agree to be accompanied home (or to an otherwise safe destination) by the support person, or another responsible party, following dosing
• Participants of childbearing potential must agree to practice an effective means of birth control throughout the duration of the study.
• Participants must agree to send outside medical records in order for the study team to verify eligibility.

You may not qualify if…

• Unstable medical conditions or serious abnormalities on complete blood count, chemistries, or ECG that in the opinion of the study physician would preclude safe participation in the trial. Some examples include:
• Congestive heart failure
• Clinically significant arrhythmias (e.g.,
• Ventricular fibrillation, torsades) or clinically significant ECG abnormality (i.e., corrected QT interval > 450)
• Recent acute myocardial infarction or
• Evidence of ischemia (in the last year)
• Malignant hypertension
• Congenital long QT syndrome
• History of valvular heart disease
• Acute renal failure
• Moderate to Severe hepatic impairment (Child Pugh class B and C).
• Respiratory failure
• Recent stroke (< 1 year from signing of consent)
• Laboratory tests abnormalities (ALT ≥ 2X upper limit of normal (ULN), aspartate aminotransferase (AST) ≥ 2X ULN, Hemoglobin<11.5, platelets <150, White Blood Cells (WBC)>10, Sodium>150, Potassium K<3.5 or K>5.2)
• Abnormal and clinically significant results on the physical examination (BP>139/89 mmHG), heart rate (HR)>90bpm,
• History of Pulmonary hypertension
• Significant central nervous system (CNS) pathology. Examples include:
• Primary or secondary cerebral neoplasm
• Epilepsy
• History of stroke
• Cerebral aneurysm
• Dementia
• Delirium
• Primary psychotic or affective psychotic disorders. Examples include current or past DSM-5 criteria for:
• Schizophrenia spectrum disorders

Where it is running

• NYU Langone Health — New York, New York, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.