Psilocybin-Assisted Psychotherapy in Treating Irritable Bowel Syndrome (IBS)
Triple-blind, placebo-controlled pilot RCT (n=10) assessing feasibility of psilocybin-assisted psychotherapy for severe IBS: single 25 mg oral psilocybin vs 100 mg niacin (active placebo) during guided psychotherapy with preparatory and integration sessions.
Details
Pilot randomized, parallel-group, triple-blind trial enrolling adults with severe IBS to assess feasibility and safety of psilocybin-assisted psychotherapy compared with an active placebo (niacin). Participants receive three preparatory therapy sessions, a medication-assisted psychotherapy session (psilocybin 25 mg or niacin 100 mg), and four integration sessions.
Outcomes include feasibility metrics, safety (labs, ECG, AEs), IBS symptom severity (IBS-SS), and other patient-reported measures; therapy is delivered by two licensed, trained psychedelic therapists who are present during sessions.