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Psychedelic Therapy

Waitlist Control 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

Study 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.Check my eligibility

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.See study design

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

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I have taken medication for my condition for at least six weeks.

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I have had my symptoms for over a year.

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I am between 21 and 64 years old.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ through study completion, an average of 4 months

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

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 outcome measures

Abdominal pain

Anxiety and depression

GI symptom-specific anxiety

+4 more

Other outcome measures

Functional magnetic resonance imaging (fMRI) functional connectivity

Heart rate variability (HRV)

Inflammatory biomarkers: Erythrocyte sedimentation rate (ESR)

+4 more

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

2020

Completed Phase 3

~3120

0 / 3Eligibility criteria met

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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are individuals who are above the age of 50 eligible to participate in this medical study?

"To meet the eligibility requirements of this clinical trial, individuals must be between 21 and 64 years old."

Answered by AI

How many individuals are currently enrolled as participants in this clinical trial?

"Indeed, according to the information provided on clinicaltrials.gov, this trial is actively seeking eligible participants. It was initially posted on January 17th, 2024 and last updated on the same day as well. The study aims to enroll a total of 14 patients from one designated site."

Answered by AI

Has the Waitlist Control method received official approval from the FDA?

"As a Phase 2 trial, the safety of the Waitlist Control intervention is estimated to be at a level of 2. While there exists some data supporting its safety, no evidence has been found regarding its efficacy."

Answered by AI

Are participants currently being recruited for this ongoing medical study?

"Indeed, as reported on clinicaltrials.gov, this study is currently seeking eligible participants. The trial was first posted on January 17th, 2024 and was last updated on the same date."

Answered by AI

What are the eligibility criteria for individuals interested in participating in this research project?

"Patients within the age range of 21 to 64 who have been diagnosed with irritable bowel syndrome (IBS) are eligible for this clinical trial. The study aims to enroll a total of 14 participants."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

2024. "Assessment of Psilocybin (TRP-8802) in Concert With Psychotherapy in Patients With Irritable Bowel Syndrome (IBS)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06206265.

All > Irritable Bowel Syndrome > Ibs