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Neurobehavioral Mechanisms of Psilocybin-assisted Treatment for AUD
NCT06349083 · View on ClinicalTrials.gov ↗
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06349083
The ClinicalTrials.gov registry entry for NCT06349083 describes a study currently listed as recruiting. It is categorized as Phase 2, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 200 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is NYU Langone Health, which has 1,204 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT06349083 reports 2 study locations spanning 2 distinct geographic areas — top geographies include Connecticut, New York. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT06349083?
The interventions under investigation include: Psilocybin (DRUG), Inactive Placebo (OTHER), Supportive therapy sessions (BEHAVIORAL). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT06349083?
This trial is sponsored by NYU Langone Health, which has 1,204 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
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.
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