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

Trial statusNot yet recruiting
Trial phaseEarly Phase 1
Trial typeInterventional
Biological sexAll
Age18-75
SponsorNYU Langone Health

About this trial

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.

Eligibility criteria

Qualifiers

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

Disqualifiers

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

Trial design

Treatments tested in this trial

  • Psilocybin 25 mg
  • Psychotherapy Treatment Session
  • Niacin 100 mg

Treatment groups

10 Participants
are divided into 2 treatment groups

Sponsors and collaborators