[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100524217":3},{"organization":4,"armGroups":7,"interventions":16,"overallOfficials":31,"centralContacts":41,"locations":50,"responsibleParty":73,"collaborators":22,"id":75,"slug":76,"hasResults":77,"nctId":78,"briefTitle":79,"officialTitle":80,"acronym":81,"eligibilityCriteria":82,"healthyVolunteers":77,"sex":83,"minAge":84,"maxAge":85,"enrollmentInfo":86,"targetDuration":22,"studyType":89,"phases":90,"briefSummary":92,"conditions":93,"keywords":101,"overallStatus":52,"whyStopped":22,"lastUpdateSubmitDate":110,"lastUpdatePostDateStruct":111,"startDateStruct":114,"completionDateStruct":116,"leadSponsor":118,"locationsCount":119},{"fullName":5,"class":6},"Central Institute of Mental Health, Mannheim","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Experimental","EXPERIMENTAL","All participants will be exposed to the Trier Social Stress Test, followed by an alcohol cue-exposure in a barlab environment and functional magnetic resonance imaging assessing neural alcohol cue-reactivity, inhibition performance, emotion processing and resting state functional connectivity twice on two consecutive days.\n\nInterventions:\n\nBehavioral: Trier Social Stress Test\n\nBehavioral: Cue-Exposure to the favorite drink in a barlab setting",[13,14,15],"Behavioral: Trier Social Stress Test","Behavioral: Barlab Cue-Exposure","Behavioral: Functional magnetic resonance imaging",[17,23,27],{"type":18,"name":19,"description":20,"armGroupLabels":21,"otherNames":22},"BEHAVIORAL","Trier Social Stress Test","Test to induce high levels of acute social stress, including actors, representing the judging panel, and a faked exam situation (15 minutes duration).",[9],null,{"type":18,"name":24,"description":25,"armGroupLabels":26,"otherNames":22},"Barlab Cue-Exposure","Participants are exposed to a bar situation with their individual favorite alcohol presented. They handle their favorite alcoholic drink and water (9 minutes duration).",[9],{"type":18,"name":28,"description":29,"armGroupLabels":30,"otherNames":22},"Functional magnetic resonance imaging","Participants undergo a fMRI screening including three different behavioral tasks assessing alcohol cue reactivity, response inhibition, and emotion processing",[9],[32,36,38],{"name":33,"affiliation":34,"role":35},"Patrick Bach, MD, PhD","Central Institute of Mental Health","PRINCIPAL_INVESTIGATOR",{"name":37,"affiliation":34,"role":35},"Falk Kiefer, MD",{"name":39,"affiliation":40,"role":35},"Clemens Kirschbaum, PhD","Technische Universität Dresden",[42,47],{"name":33,"role":43,"phone":44,"phoneExt":45,"email":46},"CONTACT","+49 621 1703","0","patrick.bach@zi-mannheim.de",{"name":48,"role":43,"phone":44,"phoneExt":45,"email":49},"Judith Zaiser","judith.zaiser@zi-mannheim.de",[51,64],{"facility":34,"status":52,"city":53,"state":54,"zip":55,"country":56,"countryCode":57,"cosmosGeoPoint":58,"geoPoint":63,"contacts":22},"RECRUITING","Mannheim","Baden-Wurttemberg","68159","Germany","DE",{"type":59,"coordinates":60},"Point",[61,62],8.46694,49.4891,{"lat":62,"lon":61},{"facility":34,"status":52,"city":53,"state":22,"zip":55,"country":56,"countryCode":57,"cosmosGeoPoint":65,"geoPoint":67,"contacts":68},{"type":59,"coordinates":66},[61,62],{"lat":62,"lon":61},[69,72],{"name":70,"role":43,"phone":71,"phoneExt":45,"email":46},"Patrick Bach, MD","+496211703",{"name":70,"role":35,"phone":22,"phoneExt":22,"email":22},{"type":74,"investigatorFullName":22,"investigatorTitle":22,"investigatorAffiliation":22,"oldNameTitle":22,"oldOrganization":22},"SPONSOR","100524217","neurobehavioral-profiles-of-adaptive-stress-responses-in-individuals-with-alcohol-use-disorder-100524217",false,"NCT06105853","Neurobehavioral Profiles of Adaptive Stress Responses in Individuals With Alcohol Use Disorder","Towards Neurobehavioral Profiles and Models of Adaptive Stress Responses and Resilience in Individuals With Alcohol Use Disorder","A03","Inclusion criteria are:\n\n* age between 16 and 65 years\n* meeting at least 2 criteria of an alcohol use disorder according to the Diagnostic and Statistical Manual of Mental Disorders (Fifth Edition) (DSM-5), yet without the need for a therapeutic intervention\n* fluency in German\n* able to understand the study procedures and give informed consent\n* willingness to use a study smartphone\n\nExclusion criteria are:\n\n* current use of drugs or medications that interact with the central nervous system or the glucocorticoid system\n* contraindications for magnetic resonance imaging\n* medical history of bipolar disorder, psychotic disorder, schizophrenia or schizophrenic spectrum disorder, or substance use disorder other than alcohol, nicotine, or cannabis\n* medical history of severe head injury or other severe central nervous system disorders or other severe somatic disorders (e.g. liver cirrhosis)\n* pregnancy","ALL","18 Years","65 Years",{"count":87,"type":88},100,"ESTIMATED","INTERVENTIONAL",[91],"NA","The goal of this observational study is to investigate longitudinal stress response profiles and adaptive versus non-adaptive stress responses in alcohol use disorder. The main questions the projects aims to answer are:\n\nWhat are the neurobehavioral underpinnings of adaptive stress responses and resilience to repeated stress exposure with regards to:\n\n* alcohol craving?\n* alcohol use?\n* their modulation by prior stress exposure, social interactions, coping strategies and individual health behavior?\n\nParticipants will:\n\n* be exposed to an established experimental stress-induction protocol, the Trier Social Stress Test\n* be exposed to their favorite drink in a bar lab environment\n* be assessed using fMRI to determine their neural alcohol cue reactivity, response inhibition, and emotion processing\n* conduct an ambulatory phase to assess stressors, alcohol craving, substance use and details on social interactions, health behavior and coping strategies using ecological momentary assessment tools.",[94,95,96,97,98,99,100],"Alcohol Use Disorder","Stress Reaction","Social Stress","Craving","Relapse","Addiction, Alcohol","Risk Behavior",[102,103,104,105,106,107,108,109],"stress","resilience","craving","sensitization","habituation","cortisol","ecological momentary assessment","alcohol use disorder","2025-04-28",{"date":112,"type":113},"2025-04-29","ACTUAL",{"date":115,"type":113},"2023-12-01",{"date":117,"type":88},"2027-06-30",{"name":5,"class":6},2]