← Back to Search

Psychedelic Therapy

Psilocybin + Psychotherapy for Irritable Bowel Syndrome

Phase 2
Recruiting
Led By Franklin King, MD
Research Sponsored by TRYP Therapeutics
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
tried at least one pharmacologic agent for at least six weeks by history
symptoms for more than 12 months by history
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through study completion, an average of 4 months
Awards & highlights
No Placebo-Only Group

Summary

This trial is recruiting participants with irritable bowel syndrome (IBS) to study the effects of a drug called TRP-8802. The study will involve two experimental sessions where participants will take an

Who is the study for?
This trial is for adults aged 21-64 with IBS who've tried at least one diet change and one medication for over six weeks, and have had symptoms for more than a year. They must have a BMI of 18.5-29.9 and their condition can't be explained by another medical issue.
What is being tested?
The study tests TRP-8802 combined with psychotherapy on IBS patients. It compares immediate treatment to an 8-week delayed group using clinician/participant ratings of depression/anxiety, subjective drug effects, pain scores, stool frequency/consistency.
What are the potential side effects?
While specific side effects are not listed here, psilocybin (like TRP-8802) may cause psychological distress or exacerbate mental health conditions during the trial's psychotherapy sessions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I have taken medication for my condition for at least six weeks.
Select...
I have had my symptoms for over a year.
Select...
I am between 21 and 64 years old.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through study completion, an average of 4 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and through study completion, an average of 4 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Incidence of Treatment-Emergent Adverse Events - Abuse-Related Psychological Events
Incidence of Treatment-Emergent Adverse Events - EKG QT Prolongation
Incidence of Treatment-Emergent Adverse Events - Hypertension
Secondary study objectives
Abdominal pain
Anxiety and depression
GI symptom-specific anxiety
+4 more
Other study objectives
Functional magnetic resonance imaging (fMRI) functional connectivity
Heart rate variability (HRV)
Inflammatory biomarkers: Erythrocyte sedimentation rate (ESR)
+4 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Group I: Waitlist ControlExperimental Treatment2 Interventions
Group II: Open Label Oral PsilocybinExperimental Treatment2 Interventions
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Psychotherapy
2014
Completed Phase 3
~3440

Find a Location

Who is running the clinical trial?

TRYP TherapeuticsLead Sponsor
3 Previous Clinical Trials
20 Total Patients Enrolled
Franklin King, MDPrincipal InvestigatorMassachusetts General Hospital
~2 spots leftby Feb 2025
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top