protocolSection identificationModule nctId: NCT06349083, orgStudyIdInfo id: 23-01227, briefTitle: Neurobehavioral Mechanisms of Psilocybin-assisted Treatment for AUD, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-07, primaryCompletionDateStruct date: 2029-01, completionDateStruct date: 2029-01, studyFirstPostDateStruct date: 2024-04-05, lastUpdatePostDateStruct date: 2024-04-05, sponsorCollaboratorsModule leadSponsor name: NYU Langone Health, class: OTHER, collaborators name: National Institute on Alcohol Abuse and Alcoholism (NIAAA), descriptionModule briefSummary: 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., conditionsModule conditions: Alcohol Use Disorder, designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: DOUBLE, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, enrollmentInfo count: 200, type: ESTIMATED, armsInterventionsModule interventions name: Psilocybin, interventions name: Inactive Placebo, interventions name: Supportive therapy sessions, outcomesModule primaryOutcomes measure: Percent change in the alcohol cue-induced Blood-oxygen-level dependent (BOLD) signal in the lateral prefrontal cortex (PFC), primaryOutcomes measure: Percent change in the alcohol cue-induced BOLD signal change in the caudate, primaryOutcomes measure: Percent change in alcohol cue-induced BOLD signal change in the ventromedial PFC (vmPFC), primaryOutcomes measure: Percent change in alcohol cue-induced BOLD signal change in the insula, primaryOutcomes measure: Percent change in negative affective cue-induced BOLD signal change in the dorsomedial PFC (dmPFC), primaryOutcomes measure: Percent change in negative affective cue-induced BOLD signal change in the supramarginal gyrus, primaryOutcomes measure: Percent change in negative affective cue-induced BOLD signal change in the amygdala, primaryOutcomes measure: Percent change in negative affective cue-induced BOLD signal change in the insula, primaryOutcomes measure: Percent change in alcohol cue-induced functional connectivity in prespecified regions of interest (ROI), primaryOutcomes measure: Percent change in negative affective cue-induced functional connectivity in prespecified regions of interest (ROI), primaryOutcomes measure: Percent change in the frequency of failed response inhibition, primaryOutcomes measure: Change in discounting rate (log(k)), primaryOutcomes measure: Change in number of set-shifting errors, primaryOutcomes measure: Average number of no heavy drinking days, primaryOutcomes measure: Change in phosphatidyl ethanol (PEth) blood levels, primaryOutcomes measure: Change in carbohydrate-deficient transferrin (CDT) blood levels, primaryOutcomes measure: Change in the Drinker Inventory of Consequences questionnaire (DrInC-2R) total score, primaryOutcomes measure: Change in PSQI global score, primaryOutcomes measure: Change in patient's self-assessed quality of life (by the SF-36 Questionnaire), primaryOutcomes measure: Change in Alcohol craving score, primaryOutcomes measure: Change in negative affect score, primaryOutcomes measure: Change in impulsivity score (Barratt impulsivity scale by the subscales and by the total score), secondaryOutcomes measure: Average number of no drinking days, secondaryOutcomes measure: Percentage of heavy drinking days, secondaryOutcomes measure: Average number of drinks per day, secondaryOutcomes measure: Percentage of abstinent days, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 65 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: NYU Langone Health, city: New York, state: New York, zip: 10016, country: United States, geoPoint lat: 40.71427, lon: -74.00597, hasResults: False