Assessment of Psilocybin (TRP-8802) in Concert With Psychotherapy in Patients With Irritable Bowel Syndrome (IBS)
This open-label randomized waitlist-controlled pilot study (n=14) tests two 25 mg oral doses of TRP-8802 (psilocybin) with psychotherapy in adults with treatment-resistant IBS.
Details
Randomized waitlist-controlled interventional pilot in adults with IBS; immediate treatment or 8-week delayed (waitlist) group with the delayed group offered the same therapy after wait period.
Intervention comprises two oral 25 mg psilocybin sessions (Days 22 and 37) delivered alongside preparatory and integration psychotherapy; outcomes include weekly worst daily pain, stool frequency/consistency and measures of anxiety and depression with follow-up to 12 months.
Screening includes ECG and labs; strict medication and substance restrictions apply and participants must be medically stable and able to complete ePRO tracking and neuroimaging assessments.