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NCT06206265 · ClinicalTrials.gov registry record · Phase 2
Assessment of Psilocybin (TRP-8802) in Concert With Psychotherapy in Patients With Irritable Bowel Syndrome (IBS)
A Phase 2 study of Irritable Bowel Syndrome, sponsored by TRYP Therapeutics.
- Active
- Registry status
- Phase 2
- Development phase
- 14
- Enrollment target
- 1
- Study location
NCT06206265: Active Phase 2 study of Irritable Bowel Syndrome, sponsored by TRYP Therapeutics.
NCT06206265 is a Phase 2 study of Irritable Bowel Syndrome that is active but no longer recruiting, run by TRYP Therapeutics. The registered enrollment target is 14 participants, below the 144-participant average among 47 other Irritable Bowel Syndrome trials with a reported enrollment target (90% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06206265, a Phase 2 study of Irritable Bowel Syndrome, is active but no longer recruiting, sponsored by TRYP Therapeutics.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 2
- Development phase
- 14 participants
- Enrollment target
- 1
- Study location
Study Summary
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
Primary Outcome
Incidence of dosing episodes resulting in patient's blood pressure \>200 systolic or \>110 diastolic for more than 15 minutes (i.e. 4 consecutive readings)
Conditions Studied
Interventions
- BEHAVIORAL Psychotherapy
- DRUG TRYP-0082
Study Locations (1)
Massachusetts
- Massachusetts General Hospital - Boston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 14 participants |
| Start Date | 2024-01-17 |
| Est. Completion | 2026-03-01 |
| Phase | Phase 2 |
What the registry record for NCT06206265 still lists
NCT06206265 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 14 participants, a relatively small participant target, below the 144-participant average among 47 other Irritable Bowel Syndrome trials with a reported enrollment target (90% lower).
The record links to 1 condition, with Irritable Bowel Syndrome appearing as the primary indexed condition, and to 2 interventions - of which Psychotherapy is the first listed.
NCT06206265 reports a single indexed study location in Massachusetts.
Frequently Asked Questions
What is clinical trial NCT06206265 about?
NCT06206265 is a clinical study titled "Assessment of Psilocybin (TRP-8802) in Concert With Psychotherapy in Patients With Irritable Bowel Syndrome (IBS)". 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...
What is the current status of trial NCT06206265?
This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 14 participants. The study started on 2024-01-17. Estimated completion is 2026-03-01.
What conditions does trial NCT06206265 study?
This clinical trial studies the following conditions: Irritable Bowel Syndrome.
What interventions are being tested in trial NCT06206265?
The interventions under investigation include: Psychotherapy (BEHAVIORAL), TRYP-0082 (DRUG).
Who is sponsoring clinical trial NCT06206265?
This trial is sponsored by TRYP Therapeutics, which has 2 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06206265 being conducted?
This trial has 1 study location across Massachusetts. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT06206265's enrollment target sits among peer trials
14 46th of 47 higher than 2 of 47 other Irritable Bowel Syndrome trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Irritable Bowel Syndrome trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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