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.

Trial Details

Participants with IBS (all subtypes) and with no exclusionary comorbid psychiatric or medical disorders will be enrolled in the study. This study will involve a randomized waitlist control design to investigate the rapid and sustained effects of TRP-8802 following two experimental sessions in which an oral dose of TRP-8802 is administered to participants with IBS. The study will include clinician and participant ratings of depression and anxiety pre- and post-drug-session, monitor and participant ratings of subjective drug effects during and after each drug session. This study comprises approximately a 28-day screening period (Days 28 to 1). After screening and enrollment, participants will be randomized to an immediate treatment group or a delayed treatment group ("waitlist control" condition). Participants in the immediate treatment group will proceed directly into three weeks of baseline and preparation (Days 1 to 18), a 2-dose administration period (Days 22 and 37), integration (Days 23, 30, 38, and 45), the End of Therapy (EOT) visit (Day 52). Participants in the delayed treatment group will wait 8 weeks after enrollment before beginning the study interventions and neuroimaging assessments. As a safety precaution, participants in the delayed treatment group will be assessed weekly via telephone calls or in-person visits during the wait period (i.e., telephone assessments during post-randomization weeks 1, 2, 3, 4, 5, 6, and 7; in-person assessment during post-randomization week 8) to assess suicide risk to determine if intervention is warranted. During week 8, IBS symptoms will also be assessed. At the end of the delay period, all participants in the delayed treatment group will complete the same intervention as the participants in the immediate treatment group. Validated and commonly used assessment tools will be used to evaluate symptoms at baseline and repeatedly after each session. The weekly average of worst daily pain score and weekly stool frequency and consistency for the 7 days immediately prior to EOT visit will be assessed for change from baseline and at the 3-, 6 , and 12- month follow-up visits (Days 120, 240, 365).

NCT Number NCT06206265

Data attribution

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