[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100515217":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":32,"centralContacts":33,"locations":39,"responsibleParty":60,"collaborators":32,"id":63,"slug":64,"hasResults":65,"nctId":66,"briefTitle":67,"officialTitle":67,"acronym":68,"eligibilityCriteria":69,"healthyVolunteers":65,"sex":70,"minAge":71,"maxAge":32,"enrollmentInfo":72,"targetDuration":32,"studyType":75,"phases":76,"briefSummary":79,"conditions":80,"keywords":32,"overallStatus":41,"whyStopped":32,"lastUpdateSubmitDate":82,"lastUpdatePostDateStruct":83,"startDateStruct":86,"completionDateStruct":88,"leadSponsor":90,"locationsCount":91},{"fullName":5,"class":6},"Brown University","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Insulin, Then Placebo","EXPERIMENTAL","There will be one single administration of intranasal human insulin (80IU) before alcohol self-administration. After a one week washout period, there will be one single intranasal administration of placebo (saline, 0.9% solution) before alcohol self administration.",[13],"Drug: Regular Human Insulin then Placebo",{"label":15,"type":10,"description":16,"interventionNames":17},"Placebo, Then Insulin","There will be one single intranasal administration of placebo (saline, 0.9% solution) before alcohol self administration. After a one week washout period, there will be one single administration of intranasal human insulin (80IU) before alcohol self-administration.",[18],"Drug: Placebo then Regular Human Insulin",[20,27],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":25},"DRUG","Regular Human Insulin then Placebo","Insulin: 80 IU (administered intranasally) THEN Placebo: 0.9% saline solution (administered intranasally)",[9],[26],"Novolin R",{"type":21,"name":28,"description":29,"armGroupLabels":30,"otherNames":31},"Placebo then Regular Human Insulin","Placebo: 0.9% saline solution (administered intranasally) THEN Insulin: 80 IU (administered intranasally)",[15],[26],null,[34],{"name":35,"role":36,"phone":37,"phoneExt":32,"email":38},"Carolina L Haass-Koffler","CONTACT","4155191385","carolina_haass-koffler@brown.edu",[40],{"facility":5,"status":41,"city":42,"state":43,"zip":44,"country":45,"countryCode":46,"cosmosGeoPoint":47,"geoPoint":52,"contacts":53},"RECRUITING","Providence","Rhode Island","02903","United States","US",{"type":48,"coordinates":49},"Point",[50,51],-71.41283,41.82399,{"lat":51,"lon":50},[54,58],{"name":55,"role":36,"phone":56,"phoneExt":32,"email":57},"Zoe Brown","(401) 863-6646","alcohol-stress-study@brown.edu",{"name":59,"role":36,"phone":56,"phoneExt":32,"email":57},"Brian Gully",{"type":61,"investigatorFullName":35,"investigatorTitle":62,"investigatorAffiliation":5,"oldNameTitle":32,"oldOrganization":32},"PRINCIPAL_INVESTIGATOR","Associate Professor","100515217","phase-1-intranasal-insulin-for-treatment-of-alcohol-use-disorder-100515217",false,"NCT05988632","Intranasal Insulin for Treatment of Alcohol Use Disorder","ITA","Inclusion Criteria:\n\n* ≥21 years\n\n  * meet any DSM-5 criteria score for AUD\n  * Individuals who, in the last month, have consumed at least the same amount of alcohol that will be administered in the laboratory procedure (i.e. to reach BrAC levels of 0.08g\u002Fdl, \\~two drinks in one occasion)\n  * BrAC=0.00g\u002FdL at each visit\n  * good health as confirmed by medical history, physical examination and lab tests\n  * willing to adhere to the study procedures\n  * understand informed consent and questionnaires in English at an 8th grade level\n  * willing to have glucose monitored by finger stick during the laboratory procedures\n\nExclusion Criteria:\n\n* • female identifying who are breastfeeding or pregnant (assessed by a urine screen)\n\n  * individuals with diabetes\n  * history of suicide attempts in the last three years\n  * current diagnosis of other substance use disorder (other than nicotine or cannabis)\n  * use of drugs (e.g. stimulants\u002Fopioids) at each alcohol administration session (by urine tox screen)\n  * cannabis intoxication (by clinical assessments)\n  * use of medications that may interact with insulin and alcohol (by Micromedex database)\n  * hypersensitivity to insulin\n  * any nasal disease\u002Fcongestion that may interfere with intranasal drug absorption;\n  * baseline hypoglycemia (blood glucose ≤65mg\u002FdL) or hyperglycemia (blood glucose \\>200mg\u002FdL) (by finger stick)","ALL","21 Years",{"count":73,"type":74},40,"ESTIMATED","INTERVENTIONAL",[77,78],"PHASE1","PHASE2","This is a randomized controlled trial (RCT), within-subject, crossover, double-blind, placebo-controlled in non-treatment-seeking individuals with Alcohol Use Disorder (AUD) (N=40, 50% female) randomized to IN insulin or placebo. In a bar laboratory setting, randomized participants will receive a single dose of IN insulin (80IU) or an IN matched placebo (0.9% Saline). Participants will undergo a cue-reactivity paradigm followed by an alcohol challenge that includes an alcohol drink designed to raise the breath alcohol content (BrAC) to 0.08g\u002FdL.",[81],"Alcohol Use Disorder","2025-08-28",{"date":84,"type":85},"2025-09-05","ACTUAL",{"date":87,"type":85},"2025-02-25",{"date":89,"type":74},"2027-01-31",{"name":5,"class":6},1]