[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100515497":3},{"organization":4,"armGroups":7,"interventions":30,"overallOfficials":10,"centralContacts":86,"locations":96,"responsibleParty":132,"collaborators":135,"id":137,"slug":138,"hasResults":139,"nctId":140,"briefTitle":141,"officialTitle":141,"acronym":142,"eligibilityCriteria":143,"healthyVolunteers":139,"sex":144,"minAge":145,"maxAge":146,"enrollmentInfo":147,"targetDuration":10,"studyType":150,"phases":10,"briefSummary":151,"conditions":152,"keywords":159,"overallStatus":99,"whyStopped":10,"lastUpdateSubmitDate":173,"lastUpdatePostDateStruct":174,"startDateStruct":177,"completionDateStruct":179,"leadSponsor":181,"locationsCount":182},{"fullName":5,"class":6},"Charite University, Berlin, Germany","OTHER",[8,26],{"label":9,"type":10,"description":11,"interventionNames":12},"alcohol use disorder (AUD)",null,"Participants with alcohol use disorder (mild to moderate or severe if no withdrawal symptoms) including:\n\n* daily smokers (at least 1 cigarette per day in last 3 months)\n* non-daily (min 1x\u002Flast 3months)\n* non-smokers",[13,14,15,16,17,18,19,20,21,22,23,24,25],"Biological: fMRI imaging (BOLD)","Biological: sMRI (structure)","Behavioral: Trier Social Stress Test","Behavioral: PIT paradigm","Behavioral: Counting Stroop task","Behavioral: No-go Simon task","Diagnostic Test: Stop Signal Task","Diagnostic Test: blood samples","Diagnostic Test: questionnaires for chronic stress","Diagnostic Test: hair samples","Diagnostic Test: saliva samples","Diagnostic Test: EMA assessment","Diagnostic Test: clinical diagnostic",{"label":27,"type":10,"description":28,"interventionNames":29},"non-AUD","Participants with a maximum of 1 AUD criteria according to DSM-5, including:\n\n* daily smokers (at least 1 cigarette per day in last 3 months)\n* non-daily (min 1x\u002Flast 3months)\n* non-smokers",[13,14,15,16,17,18,19,20,21,22,23,25],[31,36,40,45,49,53,57,62,66,70,74,78,82],{"type":32,"name":33,"description":34,"armGroupLabels":35,"otherNames":10},"BIOLOGICAL","fMRI imaging (BOLD)","Will be used to investigate neural correlates of PIT effects by measuring the blood oxygenation level dependent (BOLD) response of neural activation in the mesolimbic system.",[9,27],{"type":32,"name":37,"description":38,"armGroupLabels":39,"otherNames":10},"sMRI (structure)","Will be used to investigate neural correlates of PIT effects by identifying abnormalities in cortical gray and white matter volume.",[9,27],{"type":41,"name":42,"description":43,"armGroupLabels":44,"otherNames":10},"BEHAVIORAL","Trier Social Stress Test","Will be used to assess the effect of acute stress induction on behavioral and neural PIT effects. The induced stress is generated in a social context, where the participants are asked to prepare a job interview for their dream job and to present it in front of a three-member jury.",[9,27],{"type":41,"name":46,"description":47,"armGroupLabels":48,"otherNames":10},"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.",[9,27],{"type":41,"name":50,"description":51,"armGroupLabels":52,"otherNames":10},"Counting Stroop task","Will be used to assess interference at stimulus level. Here either one, two, three or four identical digits from 1 to 4 are shown. Number and denotation of digits are either congruent (1, 22, 333, 4444; 88 trials) or incongruent (111, 2222, 3, 4444; 88 trials). Subjects have to indicate how many digits were shown",[9,27],{"type":41,"name":54,"description":55,"armGroupLabels":56,"otherNames":10},"No-go Simon task","Will be used to measure interference at the response level and response inhibition. We will show arrows either pointing to the left or right. The arrow can either be shown on the left or the right side of the display. In congruent trials, direction and position are the same, whereas they differ in incongruent trials. Participants have to indicate the direction of the arrow and ignore the position.",[9,27],{"type":58,"name":59,"description":60,"armGroupLabels":61,"otherNames":10},"DIAGNOSTIC_TEST","Stop Signal Task","Will be used to examine inhibitory control. The participants tap the left and right side of the screen to smash two falling fruits. When the fruits pass two circles, subjects are required to tap both sides of the screen. In \"stop trials\" one of the fruits turns brown (rotten), indicating the corresponding side of the screen should not be tapped.",[9,27],{"type":58,"name":63,"description":64,"armGroupLabels":65,"otherNames":10},"blood samples","for genetic and epigenetic testing, especially for exploratory outcome prediction using polygenic risk scores.",[9,27],{"type":58,"name":67,"description":68,"armGroupLabels":69,"otherNames":10},"questionnaires for chronic stress","* Perceived Stress Scale\n* Social Readjustment Rating Scale\n* Trier Inventory for the Assessment of Chronic",[9,27],{"type":58,"name":71,"description":72,"armGroupLabels":73,"otherNames":10},"hair samples","Hair cortisol measurement (3 cm hair segments) will be used to assess chronic stress.",[9,27],{"type":58,"name":75,"description":76,"armGroupLabels":77,"otherNames":10},"saliva samples","Assessing acute stress effects in AUD.",[9,27],{"type":58,"name":79,"description":80,"armGroupLabels":81,"otherNames":10},"EMA assessment","We will use smartphones with additional mobile sensors (wearables), which will be used to measure physical activity, data on location (GPS), geolocation-based triggering of e-Diaries, self-reported stress reactivity, cue exposure (encounters with drug-related stimuli in real life), drug craving, impulsivity and drug consumption (priming doses, binges and continuous use of all drugs of abuse).",[9],{"type":58,"name":83,"description":84,"armGroupLabels":85,"otherNames":10},"clinical diagnostic","SKID-I Interview neurocognitive and psychopathological testing",[9,27],[87,92],{"name":88,"role":89,"phone":90,"phoneExt":10,"email":91},"Andreas Heinz, Prof., MD, PhD","CONTACT","0049 30 450 517 001","andreas.heinz@charite.de",{"name":93,"role":89,"phone":94,"phoneExt":10,"email":95},"Maximilian Pilhatsch, MD, PhD","0049 (351) 458 19312","max.pilhatsch@uniklinikum-dresden.de",[97,120],{"facility":98,"status":99,"city":100,"state":10,"zip":101,"country":102,"countryCode":103,"cosmosGeoPoint":104,"geoPoint":109,"contacts":110},"Charite - Universitätsmedizin Berlin","RECRUITING","Berlin","10117","Germany","DE",{"type":105,"coordinates":106},"Point",[107,108],13.41053,52.52437,{"lat":108,"lon":107},[111,113,116,118],{"name":88,"role":89,"phone":112,"phoneExt":10,"email":91},"004930450517002",{"name":114,"role":115,"phone":10,"phoneExt":10,"email":10},"Andreas Heinz, Prof., MD","PRINCIPAL_INVESTIGATOR",{"name":117,"role":115,"phone":10,"phoneExt":10,"email":10},"Maximilian Pilhatsch, PD.; MD",{"name":119,"role":115,"phone":10,"phoneExt":10,"email":10},"Michael N Smolka, Prof., MD",{"facility":121,"status":99,"city":122,"state":10,"zip":123,"country":102,"countryCode":103,"cosmosGeoPoint":124,"geoPoint":128,"contacts":129},"Technische Universität Dresden","Dresden","01307",{"type":105,"coordinates":125},[126,127],13.73832,51.05089,{"lat":127,"lon":126},[130],{"name":131,"role":89,"phone":94,"phoneExt":10,"email":95},"Maximilian Pilhatsch, Prof., MD, PhD",{"type":115,"investigatorFullName":133,"investigatorTitle":134,"investigatorAffiliation":5,"oldNameTitle":10,"oldOrganization":10},"Andreas Heinz","head of Department of Psychiatry and Psychotherapy | CCM, principle investigator",[136],{"name":121,"class":6},"100515497","cue-effects-in-human-addiction-pavlovian-to-instrumental-transfer-100515497",false,"NCT05992272","Cue Effects in Human Addiction: Pavlovian to Instrumental Transfer","ReCoDe","Inclusion Criteria:\n\n* males and females between 16-65 years of age\n* AUD subjects only: meet a minimum of 2 criteria for DSM-5 alcohol-related disorder (AUD) (not requiring withdrawal as assessed by an independent psychiatrist) and AUDIT \\> 4\n* Smokers: Daily smokers only: smoke 7 days\u002Fweek during the last three months\n* Non-daily smokers only: smoke at least once but less than 7 days\u002Fweek during the last three months\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 (Experiment 1, acute stress question)\n* Females only: luteal phase (Experiment 1, acute stress question)\n\nExclusion Criteria:\n\n* Lifetime diagnosis according to DMS-5 for: Bipolar disorder, schizophrenia, schizophrenia spectrum disorder, substance dependence except for alcohol, nicotine, or cannabis\n* Currently meeting DSM-5 diagnostic criteria for a depressive episode, suicidal ideation\n* Past 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* MR contraindications (e.g., pacemakers, metallic or electronic implants, metallic splinters, surgical staples)\n* Color vision deficiency\n* Sensorineural hearing loss of 30 dB or greater,\n* Tinnitus\n* Presence of claustrophobia\n* Acute alcohol intoxication at MRI appointments verified by breath alcohol testing or drug intoxication verified by rapid urine testing\n* For women only: not peri- or postmenopausal, not taking contraceptives (Experiment 1, acute stress question)","ALL","16 Years","65 Years",{"count":148,"type":149},300,"ESTIMATED","OBSERVATIONAL","Individuals with substance use disorders (SUD) have to cope with drug-related cues and contexts, which can affect instrumental drug seeking as shown with Pavlovian to instrumental transfer (PIT) paradigms in animals and humans. The investigators aimed to investigate the impact of acute and chronic stress on Pavlovian-to-instrumental transfer (PIT), how PIT it is associated with cognitive control abilities and whether such effects predict losing vs. regaining control in subjects with AUD. Moreover, the investigators aimed to develop a novel full transfer task that assesses both, general and specific PIT to investigate whether specific PIT differs between alcohol use disorder (AUD) and control subjects.",[153,154,155,156,157,158],"Alcohol Use Disorder (AUD)","Alcoholism","Substance Use Disorders","Smoking, Tobacco","Stress Reaction","Stress",[160,9,161,162,163,164,165,166,167,168,169,170,171,172],"substance use disorder (SUD), cognitive control\u002Finterference","Smokers","general and outcome-specific Pavlovian to instrumental transfer","chronic and acute stress","Amygdala","Stroop Test","Ventral Striatum","Neuroimaging","Humans","Surveys and Questionnaires","Reward","Fractals","Cues","2024-08-20",{"date":175,"type":176},"2024-08-21","ACTUAL",{"date":178,"type":176},"2020-11-24",{"date":180,"type":149},"2024-12-31",{"name":5,"class":6},2]