Assessment of Psilocybin (TRP-8802) in Concert With Psychotherapy in Patients With Irritable Bowel Syndrome (IBS)

This open-label pilot study (n=14) aims to assess the safety and efficacy of oral psilocybin (TRP-8802) administration in concert with psychotherapy among adult patients with irritable bowel syndrome (IBS).

Sponsored by TRYP Therapeutics and conducted at Massachusetts General Hospital, USA, the study started on January 17, 2024, with an estimated primary completion date of February 1, 2025. Participants aged 21 to 64 with IBS (any subtype) and no exclusionary comorbid psychiatric or medical disorders will be enrolled.

The study involves a randomized waitlist control design, with participants randomized to immediate treatment or delayed treatment (“waitlist control” condition). The treatment consists of two doses of oral psilocybin (25 mg each) administered under the guidance of therapists, alongside psychotherapy sessions.

The primary outcome measures include the incidence of treatment-emergent adverse events, while secondary outcome measures include changes in stool consistency, frequency, abdominal pain, anxiety, depression, severity of IBS, GI symptom-specific anxiety, and patient global impression of change. Additionally, the study will evaluate functional magnetic resonance imaging (fMRI) functional connectivity, heart rate variability (HRV), and inflammatory biomarkers. Eligible participants must meet specific inclusion criteria related to IBS diagnosis, medical stability, and other factors, while certain medical conditions and prior/concurrent therapies are exclusion criteria.

The study design is interventional, with a randomized, open-label, sequential assignment, and no masking. The study will be conducted over an average of four months, with data collected at multiple time points.

Compound Psilocybin
Country United States of America
Visit trial

Trial Details



Trial Number

Sponsors & Collaborators

Tryp Therapeutics
Tryp Therapeutics is a clinical stage drug development company developing psilocybin products for various diseases/disorders including fibromyalgia.

Massachusetts General Hospital
Massachusettes General Hospital has launched the MGH Center for the Neuroscience of Psychedelics. The announcement has now been done via YouTube, and the formal launch will be in fall 2020.

Data attribution

A large set of the trials in our database are sourced from ClinicalTrials.gov (CTG). We have modified these post to display the information in a more clear format or to correct spelling mistakes. Our database in actively updated and may show a different status (e.g. completed) if we have knowledge of this update (e.g. a published paper on the study) which isn't reflected yet on CTG. If a trial is not sourced from CTG, this is indicated on this page and you can follow the link to the alternative source of information.