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