Psilocybin-Assisted Psychotherapy in Treating Irritable Bowel Syndrome (IBS) (NCT06760533)
Pilot Proof of Concept Study Evaluating the Potential Psilocybin Assisted Psychotherapy (PAP) as a Therapeutic Tool for Patients Suffering From Severe Irritable Bowel Syndrome.
🩺 Plain-English Summary (8th-Grade Level)
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.
Who can join: To join this study, participants generally need to meet the listed inclusion criteria (6 items) and avoid the listed exclusions (65 items).
Location: NYU Langone Health — New York, New York
Age range: 18 Years to 75 Years
🧪 Interventions in This Study
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistCheck every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).
Usually NOT eligible if any of the following apply:
- Exclusion Criteria:
- 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).
🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.
📍 All Participating Trial Locations (1 Sites)
- NYU Langone Health — New York, New York
📞 Contact the Study Coordinator
Phone: (216) 835-7626
Email: Maysaa.ElZoghbi@nyulangone.org
Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
More studies in IBS - Irritable Bowel Syndrome
- Lifestyle Eating and Performance (LEAP) Program for the Treatment of Irritable Bowel Syndrome (IBS) — Riviera Beach, Florida
- Novel Pilot Study to Treat Symptoms of IBS With Diarrhea Using Combination Therapy of a Low-FODMAP Diet and a Neuromodulator — Jacksonville, Florida
- Capsule Microbiota Sampling in IBS/Functional Gastrointestinal Disease — Redwood City, California
- Evaluating the Impact of Including Virtual Dietary Education Within an Electronic Irritable Bowel Syndrome Pathway — Halifax, N.S.
Explore by condition: All IBS - Irritable Bowel Syndrome clinical trials
💡 How to Participate
- Check the checklist above to see if you may qualify.
- Contact the study coordinator using the phone/email above.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.