Pilot Proof of Concept Study Evaluating the Potential Psilocybin Assisted Psychotherapy (PAP) as a Therapeutic Tool for Patients Suffering From Severe Irritable Bowel Syndrome.
NYU Langone Health
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.
Eligibility
- Age range
- 18–75 years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * 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 sen…
Interventions
- DrugPsilocybin 25 mg
Psilocybin 25 mg (active treatment) administered during the psychotherapy treatment session.
- BehavioralPsychotherapy Treatment Session
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.
- DrugNiacin 100 mg
Niacin 100 mg (placebo) administered during the psychotherapy treatment session.
Location
- NYU Langone HealthNew York, New York