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.
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
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
Parallel
Psilocybin 25 mg
DrugPsilocybin 25 mg (active treatment) administered during the psychotherapy treatment session.
Psychotherapy Treatment Session
BehavioralThe 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 mg
DrugNiacin 100 mg (placebo) administered during the psychotherapy treatment session.
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.
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.
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.
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.
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.
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