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

NCT06760533 | Not Yet Recruiting Early Phase 1 DMC FDA Drug

• 1 other identifier: 24-00001
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• Change in Abdominal Pain Severity Numeric Rating Scale (APS-NRS) Score

  A single-item assessment of abdominal pain severity in patients with IBS. Patients rate their pain severity on a scale from 0 (no pain) to 10 (worst possible pain). The total score ranges from 0-10; lower scores indicate less severe pain.

  Baseline, Week 6

Secondary Outcomes (5)

• Change in IBS Severity Scoring System (IBS-SSS) Score

  Baseline, Week 6

• Hospital Anxiety and Depression Scale: Anxiety Score

  Baseline, Week 6

• Hospital Anxiety and Depression Scale: Depression Score

  Baseline, Week 6

• Number of Participants with "Type 3" or "Type 4" Rating on Bristol Stool Form Scale

  Baseline

• Number of Participants with "Type 3" or "Type 4" Rating on Bristol Stool Form Scale

  Month 6

Study Arms (2)

Intervention: Psilocybin

EXPERIMENTAL

Participants assigned to the intervention arm will receive psilocybin.

Drug: Psilocybin 25 mg; Behavioral: Psychotherapy Treatment Session

Control: Niacin (Placebo)

PLACEBO COMPARATOR

Participants assigned to the control arm will receive a placebo (niacin).

Behavioral: Psychotherapy Treatment Session; Drug: Niacin 100 mg

Interventions

Psilocybin 25 mg DRUG

Psilocybin 25 mg (active treatment) administered during the psychotherapy treatment session.

Intervention: Psilocybin

Psychotherapy Treatment Session BEHAVIORAL

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.

Control: Niacin (Placebo); Intervention: Psilocybin

Niacin 100 mg DRUG

Niacin 100 mg (placebo) administered during the psychotherapy treatment session.

Control: Niacin (Placebo)

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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,

Sponsors & Collaborators

• NYU Langone Health: lead

Study Sites (1)

NYU Langone Health

New York, New York, 10016, United States

Location

MeSH Terms

Conditions

Irritable Bowel Syndrome

Interventions

Psilocybin; Niacin

Condition Hierarchy (Ancestors)

Colonic Diseases, Functional; Colonic Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Indole Alkaloids; Alkaloids; Heterocyclic Compounds; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Tryptamines; Indolizidines; Indolizines; Nicotinic Acids; Acids, Heterocyclic; Pyridines; Heterocyclic Compounds, 1-Ring

Study Officials

• Maysaa El Zoghbi

  NYU Langone Health

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Maysaa El Zoghbi

CONTACT

216-835-7626; Maysaa.ElZoghbi@nyulangone.org

Aasma Shaukat

CONTACT

646-501-2906; Aasma.shaukat@nyulangone.org

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 31, 2024
• First Posted: January 7, 2025
• Study Start (Estimated): August 1, 2026
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: March 5, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)