drugset / Trial / NCT06760533

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

NCT06760533

Phase 0 Not yet recruiting 10 enrolled NYU Langone Health
RandomizedParallel-groupTriple-blindTreatment

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.

Timeline

Start
2026-08
Primary completion
2026-12
Completion
2026-12

Drugs

EvaluationDrugModalityDoseRoute
Subject Psilocybin Other / unclassified 25 mg Oral