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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 is a Early Phase 1 study that has not yet begun recruiting, run by NYU Langone Health. The registered enrollment target is 10 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06760533
The ClinicalTrials.gov registry entry for NCT06760533 describes a study currently listed as not yet recruiting, categorized as Early Phase 1. The registered enrollment target is 10 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is NYU Langone Health, which has 1,164 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which Psilocybin 25 mg is the first listed.
NCT06760533 reports 0 study locations.
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.
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