[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100578178":3},{"organization":4,"armGroups":7,"interventions":28,"overallOfficials":60,"centralContacts":64,"locations":70,"responsibleParty":91,"collaborators":93,"id":97,"slug":98,"hasResults":99,"nctId":100,"briefTitle":101,"officialTitle":102,"acronym":103,"eligibilityCriteria":104,"healthyVolunteers":99,"sex":105,"minAge":106,"maxAge":107,"enrollmentInfo":108,"targetDuration":59,"studyType":111,"phases":112,"briefSummary":115,"conditions":116,"keywords":119,"overallStatus":121,"whyStopped":59,"lastUpdateSubmitDate":122,"lastUpdatePostDateStruct":123,"startDateStruct":126,"completionDateStruct":128,"leadSponsor":130,"locationsCount":131},{"fullName":5,"class":6},"University of Pennsylvania","OTHER",[8,16,21],{"label":9,"type":10,"description":11,"interventionNames":12},"Ketone Supplement, Kenetik","ACTIVE_COMPARATOR","Kenetik: Ketone Drink supplement containing D-beta-hydroxybutyric acid and R-1,3 butanediol. D-beta-hydroxybutyric acid (C4H8O3) and 1,3 butanediol (C4H10O2). We will give 25 g of ketones 3 times. Once at an MRI visit, once at an FDG PET\u002FCT scan visit, and once at an alcohol bar lab visit.",[13,14,15],"Other: magnetic resonance imaging scan","Other: fludeoxyglucose-18 positron emission tomography scan","Other: Alcohol bar lab",{"label":17,"type":18,"description":19,"interventionNames":20},"Placebo Beverage","PLACEBO_COMPARATOR","Taste-matched placebo beverage is given 3 times. Once at an MRI visit, once at an FDG PET\u002FCT scan visit, and once at an alcohol bar lab visit.",[13,14,15],{"label":22,"type":23,"description":24,"interventionNames":25},"Alcohol beverage","EXPERIMENTAL","The alcoholic beverage will be created by using a standard dose of 0.5g\u002Fkg 0.43 g\u002Fkg for men and women respectively (50% vodka), calculated to achieve a BrAC of about 0.050%. The alcoholic beverage will be given once at bar lab 1 and again at bar lab 2.",[26,27],"Dietary Supplement: Kenetik","Other: Placebo beverage",[29,37,43,49,55],{"type":30,"name":31,"description":32,"armGroupLabels":33,"otherNames":34},"DIETARY_SUPPLEMENT","Kenetik","Drink a single dose of ketone supplement 25g, three times, randomly given at 1 of 2 MRI scan visits, 1 of 2 FDG PET\u002FCT scan visits, and 1 of 2 alcohol bar lab visits.",[22],[35,36],"D-Beta-hydroxybutyric acid and R-1,3 butanediol","Ketone supplement",{"type":6,"name":38,"description":39,"armGroupLabels":40,"otherNames":41},"magnetic resonance imaging scan","Each subject will undergo 2 research MRI scan evaluations of the brain (up to 90 min.). The MRI is FDA-approved 7.0T Magentom Prisma scanner (Siemens Medical Solutions USA, Inc., Malvern, PA) with an approved radiofrequency head coil.",[9,17],[42],"MRI scan",{"type":6,"name":44,"description":45,"armGroupLabels":46,"otherNames":47},"fludeoxyglucose-18 positron emission tomography scan","Each subject will undergo 2 FDG PET\u002FCT scans. FDG is a positron emitting radiopharmaceutical. In addition to the radioactive FDG tracer, a low-dose CT of the chest is typically performed with the FDG PET\u002FCT for the purpose of anatomical registration and attenuation correction of PET images. There are no separate diagnostic CT scans performed as part of this study.",[9,17],[48],"FDG PET\u002FCT scan",{"type":6,"name":50,"description":51,"armGroupLabels":52,"otherNames":53},"Alcohol bar lab","Each subject will undergo 2 alcohol bar labs. Subjects will drink about 2 ½ standard alcohol beverages, based on their weight to reach a breath alcohol level of 0.050%.",[9,17],[54],"Alcoholic beverages",{"type":6,"name":56,"description":57,"armGroupLabels":58,"otherNames":59},"Placebo beverage","Drink a single dose of placebo beverage, that will look and taste the same as the ketone supplement. Subjects will recieve the beverage three times, randomly given at 1 of 2 MRI scan visits, 1 of 2 FDG PET\u002FCT scan visits, and 1 of 2 alcohol bar lab visits, opisite of the Kenetik beverage.",[22],null,[61],{"name":62,"affiliation":5,"role":63},"Corinde Wiers, Ph.D.","PRINCIPAL_INVESTIGATOR",[65],{"name":66,"role":67,"phone":68,"phoneExt":59,"email":69},"Timothy Pond, MPH","CONTACT","215-746-1959","timpond@Pennmedicine.upenn.edu",[71],{"facility":72,"status":59,"city":73,"state":74,"zip":75,"country":76,"countryCode":77,"cosmosGeoPoint":78,"geoPoint":83,"contacts":84},"Center for Studies of Addiction","Philadelphia","Pennsylvania","19104","United States","US",{"type":79,"coordinates":80},"Point",[81,82],-75.16362,39.95238,{"lat":82,"lon":81},[85,86,88],{"name":66,"role":67,"phone":68,"phoneExt":59,"email":69},{"name":87,"role":63,"phone":59,"phoneExt":59,"email":59},"Corinde Wiers, Ph.D",{"name":89,"role":90,"phone":59,"phoneExt":59,"email":59},"Cindy Li, Ph.D.","SUB_INVESTIGATOR",{"type":92,"investigatorFullName":59,"investigatorTitle":59,"investigatorAffiliation":59,"oldNameTitle":59,"oldOrganization":59},"SPONSOR",[94],{"name":95,"class":96},"National Institute on Alcohol Abuse and Alcoholism (NIAAA)","NIH","100578178","phase-2-effects-of-ketones-on-brain-energetics-and-alcohol-consumption-in-alcohol-use-disorder-100578178",false,"NCT06807918","Effects of Ketones on Brain Energetics and Alcohol Consumption in Alcohol Use Disorder","Effects of Ketone Supplementation on Brain Energetics and Alcohol Consumption in Alcohol Use Disorder","KABA","Inclusion Criteria:\n\n1. Age 21-65 years old\n2. Able to provide written informed consent\n3. Meets current DSM-5 criteria for mild to moderate (established using MINI)\n4. Average weekly alcohol consumption of at least 15 standard drinks over the past month before consent (self-report)\n5. Not seeking treatment for AUD (self-report)\n\nExclusion Criteria:\n\n1. Unwilling or unable to refrain from use of alcohol, within 24 hours of Alcohol Bar Lab, MRI and PET procedures (self-report, breathalyzer).\n2. Use of psychoactive medications or medications that may affect study results (self-report, medical history).\n3. Current DSM-5 diagnosis of a major psychiatric disorder (other than alcohol, Marijuana, and nicotine use disorders) that required hospitalization or daily medication in the past year.\n4. Current significant alcohol withdrawal symptoms in the past 12 months that required medical treatment (self-report, medical history).\n5. A current, clinically significant physical disease or abnormality on the basis of medical history, physical examination, or routine laboratory evaluation that could interfere with study participation or make it hazardous for the subject to do so (e.g., bleeding disorder, pancreatitis, epilepsy, liver disease, kidney disease, or diabetes as determined by history and clinical exam); ALAT or ASAT concentration greater than 3 times the upper limit of normal (ULN), or bilirubin above the ULN. (Note-abnormal laboratory tests during screening may be repeated once).\n6. Current, major gastrointestinal (GI) diseases, such as: GERD, Crohn's disease, Irritable bowel syndrome, Ulcerative colitis, Celiac disease Diverticulitis, or other clinically significant physical disease that may interfere with the intake of the Ketone Supplement based on medical history, and evaluation of the Study Physician.\n7. Clinically significant laboratory findings that could affect brain function (e.g., HIV+).\n8. Head trauma with loss of consciousness for more than 30 minutes (self-report, medical history).\n9. Pregnant or breast-feeding\n10. Weight greater than 250lbs (Need to cap amount of alcohol give based on weight to individuals).\n11. BMI greater than 35.\n12. Self-reported claustrophobia.\n13. Contraindications to MRI (e.g., metal in the body that cannot be removed and is not MRI compatible).","ALL","21 Years","65 Years",{"count":109,"type":110},60,"ESTIMATED","INTERVENTIONAL",[113,114],"PHASE2","PHASE3","This is a randomized, double-blind, crossover trial to evaluate the immediate effects of a nutritional ketone supplement, Kenotic compared to placebo on brain function and alcohol consumption in individuals with alcohol use disorder. Participants will complete 2 MRI scans, 2 FDG PET\u002FCT scans, and 2 alcohol bar labs and will randomly receive Kenetik at one lab and the placebo at the next lab. During the bar labs participants will consume a dose of alcohol (based on weight), to bring their breath alcohol concentration to about 0.050%.",[117,118],"Alcohol Use Disorder","Ketosis",[117,118,36,120],"Magnetic Resonance Spectroscopy","NOT_YET_RECRUITING","2026-06-11",{"date":124,"type":125},"2026-06-15","ACTUAL",{"date":127,"type":110},"2026-08-01",{"date":129,"type":110},"2030-01-01",{"name":5,"class":6},1]