IBS - Irritable Bowel SyndromeEarly Phase 1NCT06760533
Psilocybin-Assisted Psychotherapy in Treating Irritable Bowel Syndrome (IBS)
A Early Phase 1 study testing Psilocybin 25 mg, Psychotherapy Treatment Session and Niacin 100 mg in people with IBS - Irritable Bowel Syndrome, run by NYU Langone Health at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- IBS - Irritable Bowel Syndrome
- What is being tested?
- Psilocybin 25 mg, Psychotherapy Treatment Session and Niacin 100 mg
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2026to Dec 2026
- Phase
- Early Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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)
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- 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
- Schizoaffective disorder
- Bipolar I or II disorder with psychotic features
- Major Depressive Disorder
- Substance induced psychotic disorders
- Paranoid personality disorder
- Delusional disorder
- Borderline personality disorder
- Any other psychotic illness
- Family history of psychotic or serious bipolar spectrum illnesses. Examples include first-degree relative with:
- Schizophrenia spectrum disorders
- Schizoaffective disorder
- Bipolar I disorder with psychotic features
- Any other psychotic illness
- High risk of adverse emotional or behavioral reaction based on investigator's clinical evaluation. Examples include:
- Agitation
- Violent behavior
- Active substance use disorders (SUDs) defined as Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) criteria for moderate or severe alcohol or drug use disorder (excluding caffeine and nicotine) within the past year
- Clinically significant suicidality or high risk of completed suicide defined as:
- 'Yes' to C-SSRS Suicidal Ideation items 4 or 5 within the last 2 months at Screening or 'since last visit' at Baseline
- Any C-SSRS Suicidal Behavior item within the past 12 months at Screening or 'since last visit' at Baseline, as defined by 'Yes' to any of the following on the C-SSRS: actual attempt, interrupted attempt, aborted attempt, or preparatory acts
- Have any suicidal ideation or thoughts, in the opinion of the study physician or PI, that presents a serious risk of suicidal or self-injurious behavior
- History of hallucinogen persisting perception disorder (HPPD)
- Pregnancy/lactation
- Cognitive impairment as defined by: Montreal Cognitive Assessment Test (MoCA) < 23
- Concurrent Medications
- Antidepressants
- Centrally-acting serotonergic agents (e.g., monoamine oxidase inhibitors (MAOIs))
- Antipsychotics (e.g., first and second generation)
- Mood stabilizers (e.g., lithium, valproic acid)
- Aldehyde dehydrogenase inhibitors (e.g., disulfiram)
- Significant inhibitors of UGT 1A0 or UGT 1A10
- Niacin
- Subjects should not also be taking serotonin-acting dietary supplements (such as 5-hydroxy-tryptophan or St. John's wort)
- Have a positive urine drug test including Amphetamines, Barbiturates, Buprenorphine, Benzodiazepines, Cocaine, Methamphetamine, 3,4-methylenedioxymethamphetamine (MDMA), Methadone, Opiates (Morphine, Oxycodone), Phencyclidine (PCP)
- Have a psychiatric condition judged to be incompatible with establishment of rapport with the study therapists or safe exposure to psilocybin
- Have any psychological or physical symptom, medication or other relevant finding prior to randomization, based on the clinical judgment of the PI or relevant clinical study staff that would make a participant unsuitable for the study.
- Have an allergy or intolerance to either psilocybin on Niacin
- Be enrolled in another clinical trial assessing intervention(s) for anxiety, depression, and/or existential distress (e.g., pharmacologic or psychotherapeutic interventions)
- Are unable to provide external medical records or refuse to provide external medical records.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Pilot Proof of Concept Study Evaluating the Potential Psilocybin Assisted Psychotherapy (PAP) as a Therapeutic Tool for Patients Suffering From Severe Irritable Bowel Syndrome.
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
- Being tested
- Psilocybin 25 mg, Psychotherapy Treatment Session, Niacin 100 mg
- Medical subject headings
- Irritable Bowel Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Psilocybin 25 mgDrug
Psilocybin 25 mg (active treatment) administered during the psychotherapy treatment session.
Psychotherapy Treatment SessionBehavioural
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.
Niacin 100 mgDrug
Niacin 100 mg (placebo) administered during the psychotherapy treatment session.
| Study group | Role | What they receive |
|---|---|---|
| Intervention: Psilocybin | Experimental | Participants assigned to the intervention arm will receive psilocybin. Receives: Drug: Psilocybin 25 mg; Behavioral: Psychotherapy Treatment Session |
| Control: Niacin (Placebo) | Placebo comparator | Participants assigned to the control arm will receive a placebo (niacin). Receives: Behavioral: Psychotherapy Treatment Session; Drug: Niacin 100 mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline, Week 6
Secondary outcomes (5)
Change in IBS Severity Scoring System (IBS-SSS) Score
The IBS-SSS asks five questions about the severity of IBS symptoms over the past 10 days: abdominal pain, abdominal distention, bowel habits, and quality of life. Each question is rated on a 100-point scale. The total score is the sum of responses and ranges from 0-500; lower scores indicate less severe symptoms, where 75-175 = mild; 175-300 = moderate; and greater than 300 = severe.
Measured: Baseline, Week 6
Hospital Anxiety and Depression Scale: Anxiety Score
The Hospital Anxiety and Depression Scale asks 14 questions related to anxiety and depression. The Anxiety subscale comprises 7 questions; each are rated on a scale from 0-3. The total Anxiety score ranges from 0-21; higher scores indicate more severe anxiety.
Measured: Baseline, Week 6
Hospital Anxiety and Depression Scale: Depression Score
The Hospital Anxiety and Depression Scale asks 14 questions related to anxiety and depression. The Depression subscale comprises 7 questions; each are rated on a scale from 0-3. The total Depression score ranges from 0-21; higher scores indicate more severe depression.
Measured: Baseline, Week 6
Number of Participants with "Type 3" or "Type 4" Rating on Bristol Stool Form Scale
The Bristol Stool Form Scale rates the consistency of stool on the following scale:
Type 1 and 2: May be difficult to pass, may indicate constipation. Type 3 and 4: Ideal stools. Type 5: Trending toward diarrhea. Type 6 and 7: Diarrhea.
This measure assesses the number of participants with Type 3 and 4 (ideal) stools.
Measured: Baseline
Number of Participants with "Type 3" or "Type 4" Rating on Bristol Stool Form Scale
The Bristol Stool Form Scale rates the consistency of stool on the following scale:
Type 1 and 2: May be difficult to pass, may indicate constipation. Type 3 and 4: Ideal stools. Type 5: Trending toward diarrhea. Type 6 and 7: Diarrhea.
This measure assesses the number of participants with Type 3 and 4 (ideal) stools.
Measured: Month 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jan 2025
- Study startAug 2026 (estimated)
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for IBS - Irritable Bowel SyndromeStudies of the same condition, open and under way.
- More trials run by NYU Langone HealthThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- NYU Langone Health
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Maysaa El Zoghbi, Principal investigator, NYU Langone Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06760533
- Sponsor's protocol ID
- 24-00001
- Status last verified
- Mar 2026
- First submitted
- 31 Dec 2024
- Last updated
- 5 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data (IPD) will not be made available to other researchers.
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Proof of Concept Study Evaluating the Potential Psilocybin Assisted Psychotherapy (PAP) as a Therapeutic Tool for Patients Suffering From Severe Irritable Bowel Syndrome.
- ClinicalTrials.gov ID
- NCT06760533
- Acronym / sponsor ID
- 24-00001
- Conditions
- IBS - Irritable Bowel Syndrome
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- NYU Langone HealthUniversity, hospital or other
- Study start
- Aug 2026 (estimated)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 7 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention: Psilocybin | Experimental | Drug: Psilocybin 25 mg, Behavioral: Psychotherapy Treatment SessionParticipants assigned to the intervention arm will receive psilocybin. |
| Control: Niacin (Placebo) | Placebo comparator | Behavioral: Psychotherapy Treatment Session, Drug: Niacin 100 mgParticipants assigned to the control arm will receive a placebo (niacin). |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (64 listed)
- 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:
- Significant central nervous system (CNS) pathology. Examples include:
- Primary psychotic or affective psychotic disorders. Examples include current or past DSM-5 criteria for:
- Family history of psychotic or serious bipolar spectrum illnesses. Examples include first-degree relative with:
- High risk of adverse emotional or behavioral reaction based on investigator's clinical evaluation. Examples include:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Psilocybin 25 mgPsilocybin 25 mg (active treatment) administered during the psychotherapy treatment session. | Drug | Intervention: Psilocybin |
| Psychotherapy Treatment SessionThe 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. | Behavioural | Control: Niacin (Placebo), Intervention: Psilocybin |
| Niacin 100 mgNiacin 100 mg (placebo) administered during the psychotherapy treatment session. | Drug | Control: Niacin (Placebo) |
Primary outcome
Change in Abdominal Pain Severity Numeric Rating Scale (APS-NRS) Score
Time frame: Baseline, Week 6
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.
5 secondary outcomes
Change in IBS Severity Scoring System (IBS-SSS) Score
Time frame: Baseline, Week 6
Hospital Anxiety and Depression Scale: Anxiety Score
Time frame: Baseline, Week 6
Hospital Anxiety and Depression Scale: Depression Score
Time frame: Baseline, Week 6
Number of Participants with "Type 3" or "Type 4" Rating on Bristol Stool Form Scale
Time frame: Baseline
Number of Participants with "Type 3" or "Type 4" Rating on Bristol Stool Form Scale
Time frame: Month 6
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Mar 2026.
- Individual participant dataSharing planned: No. Individual participant data (IPD) will not be made available to other researchers.
Related trials for IBS - Irritable Bowel Syndrome
RecruitingObservational study
Abdominal Symptoms and Rosacea: An Observational Study on the Association Between Irritable Bowel Syndrome (IBS) and the Gut-Skin Axis
IBS (Irritable Bowel Syndrome), Rosacea
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Stress Reduction and Lifestyle Modification in Irritable Bowel Syndrome Patients
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Exercise Interventions and Dietary Advice in Fibromyalgia and IBS
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A Study of Brenipatide (LY3537031) in Participants With Irritable Bowel Syndrome-Constipation (IBS-C)
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A Study of Brenipatide (LY3537031) in Participants With Irritable Bowel Syndrome-Diarrhea (IBS-D)
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Maysaa El Zoghbi principal investigator
NYU Langone Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Psilocybin 25 mg, Psychotherapy Treatment Session and Niacin 100 mg in people with IBS - Irritable Bowel Syndrome, run by NYU Langone Health at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 64 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 5 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Maysaa El Zoghbi (216-835-7626, Maysaa.ElZoghbi@nyulangone.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Abdominal Pain Severity Numeric Rating Scale (APS-NRS) Score (time frame: Baseline, Week 6). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Mar 2026.