[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100555953":3},{"organization":4,"outcomesModule":7,"designInfo":18,"detailedDescription":29,"studyPopulation":17,"armGroups":30,"interventions":42,"overallOfficials":50,"centralContacts":54,"locations":62,"responsibleParty":83,"collaborators":17,"id":85,"slug":86,"hasResults":87,"nctId":88,"briefTitle":89,"officialTitle":89,"acronym":17,"eligibilityCriteria":90,"healthyVolunteers":87,"sex":91,"minAge":92,"maxAge":17,"enrollmentInfo":93,"targetDuration":17,"studyType":96,"phases":97,"briefSummary":99,"conditions":100,"keywords":102,"overallStatus":64,"whyStopped":17,"lastUpdateSubmitDate":107,"lastUpdatePostDateStruct":108,"startDateStruct":111,"completionDateStruct":113,"leadSponsor":115,"locationsCount":116},{"fullName":5,"class":6},"University of California, San Francisco","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":17,"otherOutcomes":17},[9,13],{"measure":10,"description":11,"timeFrame":12},"Incidence of LIFU-related adverse events.","This will be assessed through monitoring for adverse events (AE) throughout the study.","Through study completion, an average of 5 weeks",{"measure":14,"description":15,"timeFrame":16},"Reward network activity in response to alcohol cues.","Reward network activity in response to alcohol vs. neutral cues before and after LIFU will be assessed using fMRI.","3 visits over 3 weeks",null,{"allocation":19,"interventionModel":20,"interventionModelDescription":21,"primaryPurpose":22,"observationalModel":17,"timePerspective":17,"maskingInfo":23},"RANDOMIZED","CROSSOVER","This is a single-center, double-blind, controlled, randomized, complete block, 2-period crossover pilot trial.","BASIC_SCIENCE",{"masking":24,"maskingDescription":25,"whoMasked":26},"DOUBLE","Due to the objectives of the study, the identity of LIFU treatments will not be known to research staff performing the data analysis or participants.",[27,28],"PARTICIPANT","OUTCOMES_ASSESSOR","This is a single-center, double-blind, controlled, randomized, complete block, 2-period crossover pilot trial. The study will assess target engagement of the ventral striatum after LIFU in patients with alcohol use disorder using resting state and task-based functional magnetic resonance imaging (fMRI).",[31,37],{"label":32,"type":33,"description":34,"interventionNames":35},"VS LIFU\u002F VPL LIFU","EXPERIMENTAL","Participants will be assigned to receive VS LIFU during the first LIFU treatment session.",[36],"Device: Low Intensity Focused Ultrasound",{"label":38,"type":39,"description":40,"interventionNames":41},"VPL LIFU\u002FVS LIFU","ACTIVE_COMPARATOR","Participants will be assigned to receive VPL LIFU during the first LIFU treatment session.",[36],[43],{"type":44,"name":45,"description":46,"armGroupLabels":47,"otherNames":48},"DEVICE","Low Intensity Focused Ultrasound","An inhibitory LIFU protocol that allows suppression of neuronal activity in the basal ganglia and thalamus will be used.",[38,32],[49],"LIFU",[51],{"name":52,"affiliation":5,"role":53},"Khaled Moussawi, MD, PhD","PRINCIPAL_INVESTIGATOR",[55,60],{"name":56,"role":57,"phone":58,"phoneExt":17,"email":59},"Catherine Borror, BS, CCRP","CONTACT","415-514-6551","TN2Lab@ucsf.edu",{"name":61,"role":57,"phone":58,"phoneExt":17,"email":59},"Sierra Brandts, BS",[63],{"facility":5,"status":64,"city":65,"state":66,"zip":67,"country":68,"countryCode":69,"cosmosGeoPoint":70,"geoPoint":75,"contacts":76},"RECRUITING","San Francisco","California","94143","United States","US",{"type":71,"coordinates":72},"Point",[73,74],-122.41942,37.77493,{"lat":74,"lon":73},[77,78,79,80],{"name":56,"role":57,"phone":58,"phoneExt":17,"email":59},{"name":61,"role":57,"phone":58,"phoneExt":17,"email":59},{"name":52,"role":53,"phone":17,"phoneExt":17,"email":17},{"name":81,"role":82,"phone":17,"phoneExt":17,"email":17},"Andrew Kayser, MD, PhD","SUB_INVESTIGATOR",{"type":84,"investigatorFullName":17,"investigatorTitle":17,"investigatorAffiliation":17,"oldNameTitle":17,"oldOrganization":17},"SPONSOR","100555953","ultrasound-neuromodulation-of-the-brain-for-alcohol-use-disorder-100555953",false,"NCT06518785","Ultrasound Neuromodulation of the Brain for Alcohol Use Disorder","Inclusion Criteria:\n\n1. Male or female ≥ 18 years of age.\n2. Documentation of an AUD diagnosis per DSM-5 criteria as evidenced by problematic pattern of alcohol use leading to clinically significant impairment or distress, as manifested by at least two of the DSM-5 criteria, occurring within a 12-month period.\n3. Be willing to undergo a brain MRI and follow study protocol.\n\nExclusion Criteria:\n\n1. Pregnant or breastfeeding.\n2. Presence of a condition or abnormality that would compromise the safety of the patient or the quality of the data.\n3. Non-English speaking.\n4. Other investigational AUD treatments.\n5. Primary psychosis, Bipolar I, or severe personality disorder.\n6. Active suicidality or history of suicide attempt in the past 5 years.\n7. Cognitive impairment (MoCA \\\u003C24)\n8. Significant medical or neurological disease, or life expectancy \\\u003C12 mos.\n9. Significant brain abnormality on brain imaging.\n10. Any MRI exclusion criteria.","ALL","18 Years",{"count":94,"type":95},25,"ESTIMATED","INTERVENTIONAL",[98],"NA","This study aims to examine the effects of Low-Intensity Focused Ultrasound (LIFU) on brain activity in patients with alcohol use disorder.",[101],"Alcohol Use Disorder",[103,104,105,106],"Substance Use Disorder","Low-Intensity Focused Ultrasound","Transcranial Focused Ultrasound","Neuromodulation","2026-09-09",{"date":109,"type":110},"2026-09-11","ACTUAL",{"date":112,"type":110},"2025-01-07",{"date":114,"type":95},"2030-09",{"name":5,"class":6},1]