[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100535832":3},{"organization":4,"armGroups":7,"interventions":33,"overallOfficials":39,"centralContacts":39,"locations":69,"responsibleParty":92,"collaborators":96,"id":103,"slug":104,"hasResults":105,"nctId":106,"briefTitle":107,"officialTitle":108,"acronym":109,"eligibilityCriteria":110,"healthyVolunteers":111,"sex":112,"minAge":113,"maxAge":114,"enrollmentInfo":115,"targetDuration":39,"studyType":118,"phases":119,"briefSummary":121,"conditions":122,"keywords":128,"overallStatus":137,"whyStopped":39,"lastUpdateSubmitDate":138,"lastUpdatePostDateStruct":139,"startDateStruct":142,"completionDateStruct":144,"leadSponsor":146,"locationsCount":147},{"fullName":5,"class":6},"Charite University, Berlin, Germany","OTHER",[8,21,25,29],{"label":9,"type":10,"description":11,"interventionNames":12},"Control (HC) - exclusion first","EXPERIMENTAL","Healthy participants without SUD Cyberball: Exclusion Day 1; Cyberball: Inclusion Day 2",[13,14,15,16,17,18,19,20],"Behavioral: PIT paradigm","Behavioral: social exclusion (Cyberball task)","Diagnostic Test: Saliva samples","Diagnostic Test: basic psychological assessment","Diagnostic Test: pre and post cyberball task","Diagnostic Test: VAS","Diagnostic Test: after cyberball task","Behavioral: social inclusion (Cyberball task)",{"label":22,"type":10,"description":23,"interventionNames":24},"Control (HC) - inclusion first","Healthy participants without SUD Cyberball: Inclusion Day 1; Cyberball: Exclusion Day 2",[13,14,15,16,17,18,19,20],{"label":26,"type":10,"description":27,"interventionNames":28},"Moderate to sever alcohol users (AUD) - exclusion first","Participants with alcohol use disorder (moderate to severe if no withdrawal symptoms) and no other substance use disorder (SUD) Cyberball: Exclusion Day 1; Cyberball: Inclusion Day 2",[13,14,15,16,17,18,19,20],{"label":30,"type":10,"description":31,"interventionNames":32},"Moderate to sever alcohol users (AUD) - inclusion first","Participants with alcohol use disorder (moderate to severe if no withdrawal symptoms) and no other substance use disorder (SUD) Cyberball: Inclusion Day 1; Cyberball: Exclusion Day 2",[13,14,15,16,17,18,19,20],[34,40,44,49,53,57,61,65],{"type":35,"name":36,"description":37,"armGroupLabels":38,"otherNames":39},"BEHAVIORAL","PIT paradigm","The paradigm consists of four parts:\n\nIn the first part, an instrumental learning task is completed in which subjects must learn which stimuli require a response and which do not. In the second part, a classical (Pavlovian) conditioning task is then completed in which subjects learn by passive viewing which stimuli are associated with certain amounts of money. The third part measures to which instrumental responses (learned in Part 1) are modulated by the presentation of the classically conditioned stimuli (learned in Part 2). At the same time drug-associated stimuli are presented in the background measuring to which extent they conflict with the learned instrumental behavior. In the last part, query trials are implemented in which the participants have to choose between two pictures to assess the relative cue value.",[9,22,26,30],null,{"type":35,"name":41,"description":42,"armGroupLabels":43,"otherNames":39},"social exclusion (Cyberball task)","Social exclusion will be assessed using the cyberball paradigm: subjects will play an online game tossing a ball to each other with two more virtual co-players. Using a cover story, we make subjects believe that the co-players really exist and that they play a live online game. During social exclusion, subjects will be systematically excluded by one co-player, and during social inclusion, ball tosses will be balanced between all three players.",[9,22,26,30],{"type":45,"name":46,"description":47,"armGroupLabels":48,"otherNames":39},"DIAGNOSTIC_TEST","Saliva samples","Assessing acute stress effects in AUD and HC subjects",[9,22,26,30],{"type":45,"name":50,"description":51,"armGroupLabels":52,"otherNames":39},"basic psychological assessment","* Sociodemographics\n* ASSIST\n* Quantity Frequency: Alcohol, tobacco\u002Fe-cigarette, Cannabis \\& other illegal drugs\n* SCID: AUD criteria and tabak use disorder life time and last year \\& acute depressive symptoms \\& symptoms for Mania and psychotic disorder\n* Edinburgh Handedness Inventory (EHI)\n* Fagerström Test for Nicotine depend (FTND)\n* Barratt Impulsiveness Scale - Kurzversion (BIS-15)\n* Allgemeine Depressionsskala (ADS)\n* State-Trait-Anxiety Inventory (STAI-T)\n* Alcohol Use Disorders Identification Test (AUDIT)\n* Cannabis Use Disorder Identification Test (CUDIT)\n* CAS -A (Alkohol)\n* Fragebogen zur Sozialen Unterstützung (F-SozU K-14)\n* Oslo-3-Items-Social-Support Scale\n* Social Skills Rating System (SSRS)\n* Trier Inventory for chronic stress (TICS)\n* Rejection Sensitivity Questionnaires (RSQ-9)\n* Need to belong scale (NTBS)\n* Fragebogen zu Gedanken und Gefühlen (FGG-14)\n* Internationale Trauma Questionnaire (ITQ)\n* Zahlen-Symbol-Test (DST)\n* Wortschatztest (verbal intelligence)",[9,22,26,30],{"type":45,"name":54,"description":55,"armGroupLabels":56,"otherNames":39},"pre and post cyberball task","Positive and Negative Affect Schedule(PANAS)",[9,22,26,30],{"type":45,"name":58,"description":59,"armGroupLabels":60,"otherNames":39},"VAS","subjective arousal, subjective stress, valence, perceived ostracisms\u002Floneliness",[9,22,26,30],{"type":45,"name":62,"description":63,"armGroupLabels":64,"otherNames":39},"after cyberball task","* Need Threat Scale\n* Manipulation check (VAS scale)",[9,22,26,30],{"type":35,"name":66,"description":67,"armGroupLabels":68,"otherNames":39},"social inclusion (Cyberball task)","Social inclusion will be assessed using the cyberball paradigm: subjects will play an online game tossing a ball to each other with two more virtual co-players. Using a cover story, we make subjects believe that the co-players really exist and that they play a live online game. During social inclusion, ball tosses will be balanced between all three players.",[9,22,26,30],[70],{"facility":71,"status":39,"city":72,"state":39,"zip":73,"country":74,"countryCode":75,"cosmosGeoPoint":76,"geoPoint":81,"contacts":82},"Charite - Universitätsmedizin Berlin","Berlin","10117","Germany","DE",{"type":77,"coordinates":78},"Point",[79,80],13.41053,52.52437,{"lat":80,"lon":79},[83,88],{"name":84,"role":85,"phone":86,"phoneExt":39,"email":87},"Andreas Heinz, Prof.,MD,PhD","CONTACT","+49 30 450 517 001","andreas.heinz@charite.de",{"name":89,"role":85,"phone":90,"phoneExt":39,"email":91},"Michael N. Smolka, Prof.,MD,PhD","+49 351 463 42201","michael.smolka@tu-dresden.de",{"type":93,"investigatorFullName":94,"investigatorTitle":95,"investigatorAffiliation":5,"oldNameTitle":39,"oldOrganization":39},"PRINCIPAL_INVESTIGATOR","Andreas Heinz","Prof., MD, PhD",[97,99,101],{"name":98,"class":6},"Heidelberg University",{"name":100,"class":6},"Zentralinstitut für Seelische Gesundheit Mannheim",{"name":102,"class":6},"Technische Universität Dresden","100535832","effect-of-social-isolation-on-the-role-of-pavlovian-mechanisms-for-control-over-alcohol-use-100535832",false,"NCT06256952","Effect of Social Isolation on the Role of Pavlovian Mechanisms for Control Over Alcohol Use","SFB TRR 265: Losing and Regaining Control Over Drug Intake B03: Role of Pavlovian Mechanisms for Control Over Substance Use WP2: Effects of Social Isolation on PIT in AUD","ReCoDe","Inclusion Criteria:\n\n* Males and females between 18-65 years of age,\n* AUD subjects: meet 4 or more criteria for DSM-5 alcohol-use disorder (not requiring withdrawal as assessed by an independent psychiatrist),\n* Currently using alcohol without a desire for abstinence,\n* Ability to consent to the study and complete the questionnaires.\n* Sufficient language skills: German\n* Availability between 3pm-6pm on 2 consecutive days,\n* existing health insurance\n\nExclusion Criteria:\n\n* Lifetime diagnosis according to DMS-5 for a: Bipolar disorder, schizophrenia, schizophrenia spectrum disorder, substance dependence except for alcohol, nicotine, cannabis, and\u002For methamphetamine\n* Currently meeting DSM-5 diagnostic criteria for depressive episode, suicidal ideation,\n* History of traumatic brain injury or severe neurological disease (such as dementia, Parkinson's disease, multiple sclerosis)\n* Pregnancy or breastfeeding,\n* Ingestion of medications known to interact with the CNS in the 10-day period prior to study participation or less than 4 half-lives after last ingestion (rapid urine test),\n* Color vision deficiency",true,"ALL","18 Years","65 Years",{"count":116,"type":117},100,"ESTIMATED","INTERVENTIONAL",[120],"NA","During the first funding period (1st FP) we investigated the impact of acute and chronic stress (Trier Social Stress Test, TSST) on Pavlovian-to-instrumental transfer (PIT). Moreover, we developed a novel full transfer task that allows assessing both general and specific PIT to investigate whether specific PIT differs between alcohol use disorder (AUD) and control subjects. We found that our online version of TSST induced stress and thereby amplified PIT effects in participants. Preliminary analyses of the full transfer task indicate that AUD participants exhibit a stronger specific PIT effect compared to controls. Based on these findings, we want to assess the following aim for this study:\n\nInvestigate the effect of experimentally induced social exclusion on alcohol-specific and general PIT effects in AUD and control participants.",[123,124,125,126,127],"Alcohol Use Disorder","Alcoholism","Stress Reaction","Ostracism","Substance Use Disorders",[129,130,131,132,133,134,135,136],"Substance use disorder (SUD)","Alcohol use disorder (AUD)","General and outcome-specific Pavlovian to instrumental transfer","Social exclusion","Humans","Surveys and Questionnaires","Reward","Cues","NOT_YET_RECRUITING","2024-08-27",{"date":140,"type":141},"2024-08-28","ACTUAL",{"date":143,"type":117},"2024-10-01",{"date":145,"type":117},"2027-06-30",{"name":5,"class":6},1]