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

Part of paid clinical trials in New York, New York.

Sponsor
NYU Langone Health
Study ID
NCT06760533
Phase
EARLY_PHASE1
Status
Not Yet Recruiting

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Conditions

  • IBS - Irritable Bowel Syndrome

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • Psilocybin 25 mg — DRUG
    Psilocybin 25 mg (active treatment) administered during the psychotherapy treatment session.
  • Psychotherapy Treatment Session — BEHAVIORAL
    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.
  • Niacin 100 mg — DRUG
    Niacin 100 mg (placebo) administered during the psychotherapy treatment session.

Study Details

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.

Key Dates

Start date
Aug 31, 2026
Status verified
Mar 2026
Primary completion
Dec 31, 2026
Completion
Dec 31, 2026

Study Design

Enrollment
10 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Intervention: Psilocybin
    Participants assigned to the intervention arm will receive psilocybin.
  • Placebo Comparator: Control: Niacin (Placebo)
    Participants assigned to the control arm will receive a placebo (niacin).

Primary Outcome Measure

Change in Abdominal Pain Severity Numeric Rating Scale (APS-NRS) Score [ Time Frame: Baseline, Week 6 ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
NYU Langone HealthNew YorkNew York10016-

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