Ignite Creation Date:
2024-05-06 @ 8:21 PM
Last Modification Date:
2024-10-26 @ 3:25 PM
Study NCT ID:
NCT06349083
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-04-05
First Post:
2024-04-01
Brief Title:
Neurobehavioral Mechanisms of Psilocybin-assisted Treatment for AUD
Sponsor:
NYU Langone Health
Organization:
NYU Langone Health
Study Overview
Official Title:
Neurobehavioral Mechanisms of Psilocybin-assisted Treatment for Alcohol Use Disorder
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-09
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 is a double-blind randomized placebo-controlled Phase 2 mechanistic clinical trial designed to evaluate the therapeutic neural mechanisms of psilocybin in patients with alcohol use disorder AUD and to determine whether further studies are warranted to study the relationship of any such effects to clinical improvement in AUD symptoms The primary aims are to evaluate the effects of psilocybin on AUD measures will include 1 fMRI neural activation and functional connectivity using a well-validated task to characterize neural and subjective response to negative affective and alcohol visual stimuli 2 alcohol use data self-report and blood biomarkers and 3 self-report measures related the NE IS and EF domains
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
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?:
None