[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100523038":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":31,"centralContacts":38,"locations":47,"responsibleParty":64,"collaborators":67,"id":70,"slug":71,"hasResults":72,"nctId":73,"briefTitle":74,"officialTitle":75,"acronym":76,"eligibilityCriteria":77,"healthyVolunteers":72,"sex":78,"minAge":79,"maxAge":80,"enrollmentInfo":81,"targetDuration":26,"studyType":84,"phases":85,"briefSummary":88,"conditions":89,"keywords":92,"overallStatus":50,"whyStopped":26,"lastUpdateSubmitDate":96,"lastUpdatePostDateStruct":97,"startDateStruct":100,"completionDateStruct":102,"leadSponsor":104,"locationsCount":105},{"fullName":5,"class":6},"University Hospital of North Norway","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Intervention group","EXPERIMENTAL","Ketamine, 0,8 mg\u002Fkg body weight, given as four single doses (biweekly for two weeks)",[13],"Drug: Ketamine Hydrochloride",{"label":15,"type":16,"description":17,"interventionNames":18},"Control group","ACTIVE_COMPARATOR","Midazolam, 0,8 mg\u002Fkg body weight, given as four single doses (biweekly for two weeks)",[19],"Drug: Midazolam Hydrochloride",[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DRUG","Ketamine Hydrochloride","Four single-doses, given two times per week for two weeks Dose: 0,8 mg\u002Fkg body weight Route of administration: intravenous infusions over 40 minutes",[9],null,{"type":22,"name":28,"description":29,"armGroupLabels":30,"otherNames":26},"Midazolam Hydrochloride","Four single-doses, given two times per week for two weeks Dose: 0,02 mg\u002Fkg body weight Route of administration: intravenous infusions over 40 minutes",[15],[32,35],{"name":33,"affiliation":5,"role":34},"Ole K Grønli, Assoc Prof","STUDY_DIRECTOR",{"name":36,"affiliation":5,"role":37},"Andreas W Blomkvist, M.D.","PRINCIPAL_INVESTIGATOR",[39,44],{"name":36,"role":40,"phone":41,"phoneExt":42,"email":43},"CONTACT","41694637","+47","andreas.wahl.blomkvist@unn.no",{"name":33,"role":40,"phone":45,"phoneExt":42,"email":46},"91713535","ole.k.gronli@unn.no",[48],{"facility":49,"status":50,"city":51,"state":26,"zip":26,"country":52,"countryCode":53,"cosmosGeoPoint":54,"geoPoint":59,"contacts":60},"Department of Addiction, University Hospital of North Norway","RECRUITING","Tromsø","Norway","NO",{"type":55,"coordinates":56},"Point",[57,58],18.95508,69.6489,{"lat":58,"lon":57},[61],{"name":62,"role":40,"phone":63,"phoneExt":26,"email":43},"Andreas W Blomkvist, Senior consultant","+4741694637",{"type":37,"investigatorFullName":65,"investigatorTitle":66,"investigatorAffiliation":5,"oldNameTitle":26,"oldOrganization":26},"Andreas Wahl Blomkvist","Principal Investigator",[68],{"name":69,"class":6},"University of Exeter","100523038","phase-1-ketamine-for-combined-depression-and-alcohol-use-disorder-100523038",false,"NCT06090422","Ketamine for Combined Depression and Alcohol Use Disorder","Ketamine for Combined Depression and Alcohol Use Disorder: A Blinded Randomized Active Placebo-controlled Trial (the KeDA Trial)","KeDA","Please contact the project team for a full and detailed list of inclusion\u002Fexclusion criteria\n\nInclusion Criteria:\n\n* Currently abstinent from alcohol\n* At least moderate depression without psychotic features\n* Minimum Montgomery-Åsberg Depression Rating Scale (MADRS) of 20\n* Alcohol dependence\n* Admitted for inpatient addiction therapy at University Hospital of North Norway\n\nExclusion Criteria:\n\n* Intoxicated or in significant withdrawal from alcohol or drug use\n* Not able to give adequate informed consent\n* Current or past history of schizophrenia, schizophreniform disorder, paranoid delusional disorder, schizoaffective disorder\n* Current or historical diagnosis of schizophrenia in a first degree relative\n* Cardiovascular conditions: recent stroke (\\\u003C 1 year from informed consent), recent myocardial infarction (\\\u003C 1 year from informed consent), uncontrolled hypertension (\\>150\u002F100 mm Hg) or recent arrhythmia (\\\u003C 1 year from informed consent; clinically significant arrhythmia requiring treatment at hospital)\n* Liver (Child-Pughs Class C) or kidney (Creatinin clearance \\\u003C 30 mL\u002Fmin) failure\n* Heart failure (the New York Heart Association Functional Classification (NYHA) class III or IV)\n* Chronic respiratory failure (requiring long-term oxygen therapy (LTOT) and\u002For Global Initiative for Chronic Obstructive Lung Disease system (GOLD) stage 3 or higher)\n* Previous anaphylactic reaction to ketamine or midazolam\n* Illegal use of ketamine the last 6 months\n* Pregnancy or breastfeeding\n* Current or suspected increased intracranial pressure","ALL","18 Years","65 Years",{"count":82,"type":83},34,"ESTIMATED","INTERVENTIONAL",[86,87],"PHASE1","PHASE2","The goal of this clinical trial is to investigate the effects of ketamine, in combination with standard inpatient addiction therapy, for adults with depression and alcohol use disorder. After screening and enrollment, participants will undergo baseline assessments of depression, measures of alcohol use and craving, as well as neurocognitive function. Participants will then be randomized to either ketamine (intervention) or midazolam (control). All participants will be admitted for standard inpatient addiction therapy while receiving ketamine or midazolam. Measures on safety, depression and alcohol use disorder will be repeatedly assessed during and after treatment. Final follow-up assessment is scheduled 6 months after baseline assessment.",[90,91],"Depression","Alcohol Use Disorder",[90,93,94,95],"Alcohol use disorder","Ketamine","Addiction","2026-06-22",{"date":98,"type":99},"2026-06-23","ACTUAL",{"date":101,"type":99},"2025-01-20",{"date":103,"type":83},"2027-07-01",{"name":5,"class":6},1]