Ignite Creation Date:
2025-12-25 @ 2:54 AM
Ignite Modification Date:
2026-01-01 @ 1:13 AM
Study NCT ID:
NCT06760533
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-04-09
First Post:
2024-12-31
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Psilocybin-Assisted Psychotherapy in Treating Irritable Bowel Syndrome (IBS)
Sponsor:
NYU Langone Health
Organization:
Study Overview
Official Title:
Pilot Proof of Concept Study Evaluating the Potential Psilocybin Assisted Psychotherapy (PAP) as a Therapeutic Tool for Patients Suffering From Severe Irritable Bowel Syndrome.
Status:
NOT_YET_RECRUITING
Status Verified Date:
2025-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: