Pilot Proof of Concept Study Evaluating the Potential Psilocybin Assisted Psychotherapy (PAP) as a Therapeutic Tool for Patients Suffering From Severe Irritable Bowel Syndrome.

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

Interventions

• Drug
  Psilocybin 25 mg

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

• Behavioral
  Psychotherapy 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.

• Drug
  Niacin 100 mg

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

Location