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NCT06760533 · ClinicalTrials.gov registry record · Early Phase 1
Psilocybin-Assisted Psychotherapy in Treating Irritable Bowel Syndrome (IBS)
A Early Phase 1 study, sponsored by NYU Langone Health.
- Not yet
- Registry status
- Early Phase 1
- Development phase
- 10
- Enrollment target
NCT06760533: Clinical Trial Early Phase 1 study, sponsored by NYU Langone Health.
NCT06760533 is a Early Phase 1 study that has not yet begun recruiting, run by NYU Langone Health. The registered enrollment target is 10 participants, below the 53-participant average among 2,764 other Early Phase 1 trials with a reported enrollment target (81% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06760533, a Early Phase 1 study, has not yet begun recruiting, sponsored by NYU Langone Health.
- NOT YET RECRUITING
- Registry status
- Early Phase 1
- Development phase
- 10 participants
- Enrollment target
Study Summary
This study will serve as a pilot randomized controlled trial to assess the feasibility of Psilocybin-Assisted Psychotherapy (PAP) in Treating Irritable Bowel Syndrome (IBS). Patients with severe IBS will undergo 3 pre-psychotherapy sessions with two licensed and trained psychedelic therapists, then will be randomized to undergo a guided psychotherapy session with single 25 mg oral "high" dose of psilocybin or a single 100 mg dose of niacin (active placebo) and attend 4 post-therapy integration sessions.
Primary Outcome
A single-item assessment of abdominal pain severity in patients with IBS. Patients rate their pain severity on a scale from 0 (no pain) to 10 (worst possible pain). The total score ranges from 0-10; lower scores indicate less severe pain.
Interventions
- DRUG Psilocybin 25 mg
- DRUG Niacin 100 mg
- BEHAVIORAL Psychotherapy Treatment Session
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 10 participants |
| Start Date | 2026-08 |
| Est. Completion | 2026-12 |
| Phase | Early Phase 1 |
What is known before NCT06760533 opens enrollment
NCT06760533 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 10 participants, a relatively small participant target, below the 53-participant average among 2,764 other Early Phase 1 trials with a reported enrollment target (81% lower).
The record links to 0 conditions, and to 3 interventions - of which Psilocybin 25 mg is the first listed.
NCT06760533 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT06760533 about?
NCT06760533 is a clinical study titled "Psilocybin-Assisted Psychotherapy in Treating Irritable Bowel Syndrome (IBS)". This study will serve as a pilot randomized controlled trial to assess the feasibility of Psilocybin-Assisted Psychotherapy (PAP) in Treating Irritable Bowel Syndrome (IBS). Patients with severe IBS will undergo 3 pre-psychotherapy sessions with two licensed and trained psychedelic therapists, then ...
What is the current status of trial NCT06760533?
This trial is currently not yet recruiting. It is a Early Phase 1 study. The enrollment target is 10 participants. The study started on 2026-08. Estimated completion is 2026-12.
What interventions are being tested in trial NCT06760533?
The interventions under investigation include: Psilocybin 25 mg (DRUG), Niacin 100 mg (DRUG), Psychotherapy Treatment Session (BEHAVIORAL).
Who is sponsoring clinical trial NCT06760533?
This trial is sponsored by NYU Langone Health, which has 1,164 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT06760533's enrollment target sits among peer trials
10 1628th of 2000 higher than 256 of 2,000 other Early Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Early Phase 1 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.
Source ClinicalTrials.gov registry export · 2026-08-08
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