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NCT06349083 · ClinicalTrials.gov registry record · Phase 2
Neurobehavioral Mechanisms of Psilocybin-assisted Treatment for AUD
A Phase 2 study of Alcohol Use Disorder, sponsored by NYU Langone Health.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 200
- Enrollment target
- 2
- Study locations
NCT06349083: Recruiting Phase 2 study of Alcohol Use Disorder, sponsored by NYU Langone Health.
NCT06349083 is a Phase 2 study of Alcohol Use Disorder that is actively recruiting participants, run by NYU Langone Health. The registered enrollment target is 200 participants, below the 327-participant average among 184 other Alcohol Use Disorder trials with a reported enrollment target (39% lower). The trial reports 2 study locations across 2 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06349083, a Phase 2 study of Alcohol Use Disorder, is actively recruiting participants, sponsored by NYU Langone Health.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 200 participants
- Enrollment target
- 2
- Study locations
Study 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.
Primary Outcome
Percentage change in the BOLD signal is the difference in fMRI signal between the baseline condition (B) and the alcohol cue-induced task condition (T); percent signal change = (T-B)/B×100%. A positive value of the percentage change in BOLD signal indicates up-regulation of BOLD signal.
Conditions Studied
Interventions
- DRUG Psilocybin
- OTHER Inactive Placebo
- BEHAVIORAL Supportive therapy sessions
Study Locations (2)
Connecticut
- Silver Hill Hospital - New Canaan
New York
- NYU Langone Health - New York
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 200 participants |
| Start Date | 2025-08-26 |
| Est. Completion | 2029-05 |
| Phase | Phase 2 |
What NCT06349083 shows while recruiting
NCT06349083 is an interventional study that assigns participants to a tested intervention. The registered 200 participants enrollment target is mid-sized for trials with a published cap, below the 327-participant average among 184 other Alcohol Use Disorder trials with a reported enrollment target (39% lower).
The record links to 1 condition, with Alcohol Use Disorder appearing as the primary indexed condition, and to 3 interventions - of which Psilocybin is the first listed.
NCT06349083 reports a single indexed study location in Connecticut, New York.
Frequently Asked Questions
What is clinical trial NCT06349083 about?
NCT06349083 is a clinical study titled "Neurobehavioral Mechanisms of Psilocybin-assisted Treatment for AUD". 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 eff...
What is the current status of trial NCT06349083?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 200 participants. The study started on 2025-08-26. Estimated completion is 2029-05.
What conditions does trial NCT06349083 study?
This clinical trial studies the following conditions: Alcohol Use Disorder.
What interventions are being tested in trial NCT06349083?
The interventions under investigation include: Psilocybin (DRUG), Inactive Placebo (OTHER), Supportive therapy sessions (BEHAVIORAL).
Who is sponsoring clinical trial NCT06349083?
This trial is sponsored by NYU Langone Health, which has 1,164 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06349083 being conducted?
This trial has 2 study locations across Connecticut, New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Alcohol Use Disorder
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT06349083's enrollment target sits among peer trials
200 43rd of 184 higher than 137 of 184 other Alcohol Use Disorder trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Alcohol Use Disorder trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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