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Psilocybin-Assisted Psychotherapy in Treating Irritable Bowel Syndrome (IBS)

NCT06760533 · Status: NOT_YET_RECRUITING · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2026-03-05

No results posted yet for this 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.

Conditions

  • IBS - Irritable Bowel Syndrome

Interventions

DRUG

Psilocybin 25 mg

Psilocybin 25 mg (active treatment) administered during the psychotherapy treatment session.

BEHAVIORAL

Psychotherapy Treatment Session

The psychotherapy treatment sessions will be conducted by two therapists, who will be both present for all the sessions during three phases of treatment: Preparation, Medication Administration, and Integration.

DRUG

Niacin 100 mg

Niacin 100 mg (placebo) administered during the psychotherapy treatment session.

Sponsors & Collaborators

Principal Investigators

  • Maysaa El Zoghbi · NYU Langone Health

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-08-31
Primary Completion
2026-12-31
Completion
2026-12-31
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06760533 on ClinicalTrials.gov