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Neurobehavioral Mechanisms of Psilocybin-assisted Treatment for AUD

StatusRecruiting
PhasePhase 2
Started2026-09-01
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary endpoint added 22 → 23 primary endpoints
See other at-risk trials from NYU Langone Health

Amendment history

2026-09-01
Study Status, Contacts/Locations v8
Re-verified, no change to tracked fields
2026-08-11
Study Status v7
Start date2025-08-26→2026-09-01
2026-08-05
Study Status, Arms and Interventions, Outcome Measures, Eligibility, Contacts/Locations v6
Primary endpoint(s) modified22 to 23 entries
WasAverage number of no heavy drinking days, Change in Alcohol craving score, Change in PSQI global score, Change in carbohydrate-deficient transferrin (CDT) blood levels, Change in discounting rate (log(k)), Change in impulsivity score (Barratt impulsivity scale by the subscales and by the total score), Change in negative affect score, Change in number of set-shifting errors, Change in patient's self-assessed quality of life (by the SF-36 Questionnaire), Change in phosphatidyl ethanol (PEth) blood levels, Change in the Drinker Inventory of Consequences questionnaire (DrInC-2R) total score, Percent change in alcohol cue-induced BOLD signal change in the insula, Percent change in alcohol cue-induced BOLD signal change in the ventromedial PFC (vmPFC), Percent change in alcohol cue-induced functional connectivity in prespecified regions of interest (ROI), Percent change in negative affective cue-induced BOLD signal change in the amygdala, Percent change in negative affective cue-induced BOLD signal change in the dorsomedial PFC (dmPFC), Percent change in negative affective cue-induced BOLD signal change in the insula, Percent change in negative affective cue-induced BOLD signal change in the supramarginal gyrus, Percent change in negative affective cue-induced functional connectivity in prespecified regions of interest (ROI), Percent change in the alcohol cue-induced BOLD signal change in the caudate, Percent change in the alcohol cue-induced Blood-oxygen-level dependent (BOLD) signal in the lateral prefrontal cortex (PFC), Percent change in the frequency of failed response inhibition
NowChange in Alcohol craving score, Change in PSQI global score, Change in carbohydrate-deficient transferrin (CDT) blood levels, Change in discounting rate (log(k)), Change in impulsivity score (Barratt impulsivity scale by the subscales and by the total score), Change in negative affect score, Change in participant-level reference points, Change in patient's self-assessed health-related quality of life (by the SF-36 Questionnaire), Change in phosphatidyl ethanol (PEth) blood levels, Change in the Drinker Inventory of Consequences questionnaire (DrInC-2R) total score, Percent change in alcohol cue-induced BOLD signal change in the inferior frontal gyrus (IFG), Percent change in alcohol cue-induced BOLD signal change in the insula, Percent change in alcohol cue-induced BOLD signal change in the ventromedial PFC (vmPFC), Percent change in alcohol cue-induced functional connectivity in prespecified regions of interest (ROI), Percent change in negative affective cue-induced BOLD signal change in the amygdala, Percent change in negative affective cue-induced BOLD signal change in the dorsomedial PFC (dmPFC), Percent change in negative affective cue-induced BOLD signal change in the insula, Percent change in negative affective cue-induced BOLD signal change in the supramarginal gyrus, Percent change in negative affective cue-induced functional connectivity in prespecified regions of interest (ROI), Percent change in the alcohol cue-induced BOLD signal change in the caudate, Percent change in the alcohol cue-induced Blood-oxygen-level dependent (BOLD) signal in the lateral prefrontal cortex (PFC), Percent change in the frequency of failed response inhibition, Percentage of no heavy drinking days
Eligibility criteria+649 characters
[...] ion may be re-evaluated within the 30-day screening period. This criterion will also be reassessed at Baseline, on Day 0, and on Day 2. Those not meeting the criterion may be rescheduled once within 14 days if the criterion is likely to resolve within 14 days in the judgement of the Investigator). Are able to read, speak, and understand English, as document [...] Screening visit. Have DSM-5 diagnosis of moderate or severe Alcohol Use Disorder (AUD) (using MINI) AreEligible inparticipants must either (a) not currently receiving treatment atfor Silveralcohol Hilluse Hospitaldisorder (either in Resident [...] [...]
Secondary endpoints4 to 7 entries
AverageTime numberto First Drinking Day Time to First Heavy Drinking Day Change in World Health Organization (WHO) Risk drinking levels Probability of noHaving drinkingNo daysDrinking Days PercentageProbability of heavyHaving drinkingNo daysHeavy Drinking Days
2026-07-06
Study Status, Contacts/Locations v5
Primary completion date2029-05→2030-05
Completion date2029-05→2030-05
Study sites2→1
2025-12-18
Not Yet Recruiting→Recruiting Study Identification, Study Status, Contacts/Locations v4
Trial statusNot Yet Recruiting→Recruiting
Start dateestimated 2025-07→confirmed 2025-08-26
Study sitesdetails revised at 2 of 2 sites
Show 3 earlier versions
2025-07-02
Study Status v3
Primary completion date2029-01→2029-05
Completion date2029-01→2029-05
Start date2025-04→2025-07
2025-04-08
Study Status, Contacts/Locations v2
Start date2025-01→2025-04
Study sites1→2
2024-09-19
Study Status v1
Start date2024-07→2025-01
2024-04-01
Original filing
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.
Trial Details
NCT Number NCT06349083
Lead Sponsor NYU Langone Health
Collaborators: National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Conditions Alcohol Use Disorder
Enrollment 200 participants
Start Date 2026-09-01
Primary Completion 2030-05 (estimated)
Study Completion 2030-05 (estimated)
Updated on ClinicalTrials.gov 2026-09-02