[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100569995":3},{"organization":4,"armGroups":7,"interventions":31,"overallOfficials":10,"centralContacts":10,"locations":59,"responsibleParty":85,"collaborators":87,"id":92,"slug":93,"hasResults":94,"nctId":95,"briefTitle":96,"officialTitle":97,"acronym":98,"eligibilityCriteria":99,"healthyVolunteers":94,"sex":100,"minAge":101,"maxAge":102,"enrollmentInfo":103,"targetDuration":10,"studyType":106,"phases":10,"briefSummary":107,"conditions":108,"keywords":116,"overallStatus":62,"whyStopped":10,"lastUpdateSubmitDate":130,"lastUpdatePostDateStruct":131,"startDateStruct":134,"completionDateStruct":136,"leadSponsor":138,"locationsCount":139},{"fullName":5,"class":6},"Technische Universität Dresden","OTHER",[8,19,23,27],{"label":9,"type":10,"description":11,"interventionNames":12},"Alcohol use disorder (AUD)",null,"Participants with alcohol use disorder (moderate to severe if no withdrawal symptoms) and no other substance use disorder (SUD)",[13,14,15,16,17,18],"Biological: fMRI imaging (BOLD)","Biological: sMRI (structure)","Behavioral: Pavlovian-to-instrumental transfer (PIT) paradigm","Diagnostic Test: Basic psychological assessment (interview)","Diagnostic Test: Basic psychological assessment (questionnaires)","Behavioral: Neuropsychological tests",{"label":20,"type":10,"description":21,"interventionNames":22},"Alcohol use disorder (AUD) and Substance use disorder (SUD)","Participants with Alcohol use disorder (AUD) and comorbid Substance use disorder (SUD) (moderate to severe cases without withdrawal symptoms) including:\n\nParticipants with alcohol use disorder (AUD) and\u002For cannabis use disorder and\u002For methamphetamine use disorder and\u002For amphetamine use disorder and\u002For cocaine use disorder.",[13,14,15,16,17,18],{"label":24,"type":10,"description":25,"interventionNames":26},"Non-AUD Substance use disorder (SUD)","Participants with substance use disorder (moderate to severe cases without withdrawal symptoms) without alcohol use disorder (AUD) including:\n\nParticipants with methamphetamine use disorder and\u002For cannabis use disorder and\u002For amphetamine use disorder and\u002For cocaine use disorder",[13,14,15,16,17,18],{"label":28,"type":10,"description":29,"interventionNames":30},"Control group","Healthy participants without AUD or SUD",[13,14,15,16,17,18],[32,37,41,46,51,55],{"type":33,"name":34,"description":35,"armGroupLabels":36,"otherNames":10},"BIOLOGICAL","fMRI imaging (BOLD)","Will be used to investigate neural correlates of Pavlovian-to-instrumental transfer (PIT) effects by measuring the blood oxygenation level dependent (BOLD) response of neural activation in the mesolimbic system.",[9,20,28,24],{"type":33,"name":38,"description":39,"armGroupLabels":40,"otherNames":10},"sMRI (structure)","Will be used to investigate neural correlates of PIT effects by identifying abnormalities in cortical gray and white matter volume.",[9,20,28,24],{"type":42,"name":43,"description":44,"armGroupLabels":45,"otherNames":10},"BEHAVIORAL","Pavlovian-to-instrumental transfer (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.",[9,20,28,24],{"type":47,"name":48,"description":49,"armGroupLabels":50,"otherNames":10},"DIAGNOSTIC_TEST","Basic psychological assessment (interview)","* Alcohol, Smoking and Substance Involvement Screening Test (ASSIST)\n* Quantity Frequency: Alcohol, Cannabis, (Meth-) Amphetamine, Cocaine)\n* SCID: AUD and SUD (Cannabis, Methamphetamine, Amphetamine, Cocaine) criteria and last year \\& depressive symptoms \\& symptoms for Mania and psychotic disorder (acute and lifetime) MiniDIPS psychotic disorders",[9,20,28,24],{"type":47,"name":52,"description":53,"armGroupLabels":54,"otherNames":10},"Basic psychological assessment (questionnaires)","* Sociodemographics\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 and STAI-S)\n* Adult ADHD Self-Report Scale (ASRS)\n* Alcohol Use Disorders Identification Test (AUDIT)\n* CAS -A (Alkohol)\n* Cannabis Use Disorders Identification Test (CUDIT)\n* Fragebogen zu Gedanken und Gefühle 14 Items (FGG-14)\n* Fragebogen zur Sozialen Unterstützung (F-SozU-K14)\n* Trierer Inventar zum chronischen Stress (TICS)\n* Oslo 3-Items-Social-Support Scale (Oslo-3)\n* Social Readjustment Rating Scale (SRRS)\n* International Trauma Questionnaire (ITQ)\n* Positive and Negative Affect Schedule (PANAS)",[9,20,28,24],{"type":42,"name":56,"description":57,"armGroupLabels":58,"otherNames":10},"Neuropsychological tests","* Digit-Symbol-Test (DST)\n* Digit Span Task\n* Value-based decision-making task (VBDM)",[9,20,28,24],[60],{"facility":61,"status":62,"city":63,"state":10,"zip":10,"country":64,"countryCode":65,"cosmosGeoPoint":66,"geoPoint":71,"contacts":72},"Department of Psychiatry and Psychotherapy, Technische Universität Dresden","RECRUITING","Dresden","Germany","DE",{"type":67,"coordinates":68},"Point",[69,70],13.73832,51.05089,{"lat":70,"lon":69},[73,78,80,81,83],{"name":74,"role":75,"phone":76,"phoneExt":10,"email":77},"Maximilian Pilhatsch, Prof. Dr.","CONTACT","0049 35 146 342 211","maximilian.pilhatsch@tu-dresden.de",{"name":79,"role":75,"phone":10,"phoneExt":10,"email":10},"Michael Smolka, Prof. Dr.",{"name":74,"role":75,"phone":10,"phoneExt":10,"email":10},{"name":82,"role":75,"phone":10,"phoneExt":10,"email":10},"Michael N. Smolka, Prof. Dr.",{"name":84,"role":75,"phone":10,"phoneExt":10,"email":10},"Andreas Heinz, Prof. Dr.",{"type":86,"investigatorFullName":10,"investigatorTitle":10,"investigatorAffiliation":10,"oldNameTitle":10,"oldOrganization":10},"SPONSOR",[88,90],{"name":89,"class":6},"Charite University, Berlin, Germany",{"name":91,"class":6},"Central Institute of Mental Health, Mannheim","100569995","role-of-pavlovian-mechanisms-for-control-over-substance-use-100569995",false,"NCT06701487","Role of Pavlovian Mechanisms for Control Over Substance Use","SFB TRR 265: Losing and Regaining Control Over Drug Intake Work Package 1 of Project B03: General and Specific Pavlovian-to-Instrumental Transfer Effects in a Range of Substance Use Disorders","ReCoDe","Inclusion Criteria:\n\n* Men and women between 18-65 years of age,\n* AUD, and\u002For SUD subjects only: meet 4 or more criteria for DSM-5 alcohol-related and\u002For substance-related (cannabis, amphetamine, methamphetamine or cocaine 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(German) and motor skills for using PC\n* existing health insurance\n\nExclusion Criteria:\n\n* Lifetime diagnosis of DSM-5 bipolar disorder or schizophrenia or schizophrenia spectrum disorder (if induced by drugs, it should happen more than a month ago)\n* Current threshold DSM-5 diagnosis of major depressive disorder, or presence of suicidal intention\n* High risk (≤ 26) ASSIST scores in other substances other than alcohol, amphetamine, methamphetamine, cannabis, cocaine, tobacco\n* History of traumatic brain injury or severe neurological disease (such as Dementia, Parkinson's disease, multiple sclerosis, Epilepsy, Meningitis, Stroke)\n* Pregnancy or breastfeeding,\n* Ingestion of medications known to interact with the dopamine system in the 10-day period prior to study participation or less than 4 half-lives after last ingestion (rapid urine test); A detailed list of permitted medication can be added upon request\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 and\n* Acute alcohol, substance (cannabis, or methamphetamine, amphetamine, cocaine) intoxication at assessement day verified by breath alcohol tests and drug intoxication verified by rapid urine test.","ALL","18 Years","65 Years",{"count":104,"type":105},200,"ESTIMATED","OBSERVATIONAL","During the first funding period (1st FP), the investigators developed a novel full Pavlovian-to-instrumental transfer (PIT) task that allows assessing both, general and specific PIT to investigate whether specific PIT differs between alcohol use disorder (AUD) and control subjects. Preliminary analyses of the full transfer task indicate that AUD participants exhibit a stronger specific PIT effect compared to controls. Based on these findings, the investigators want to compare specific and general PIT effects in patients with moderate to severe substance use disorders (alcohol, cannabis, methamphetamine, amphetamine and cocaine) to healthy controls on the behavioral and neural level (fMRI).",[109,110,111,112,113,114,115],"Alcohol Use Disorder (AUD)","Alcoholism","Substance Use Disorders","Cannabis Use Disorder","Methamphetamine-dependence","Amphetamine Use Disorder","Cocaine Use Disorder",[117,118,119,114,115,109,120,121,122,123,124,125,126,127,128,129],"Substance Use Disorder (SUD)","Cannabise Use Disorder","Methamphetamine Use Disorder","Pavlovian-to-Instrumental Transfer (PIT)","General Pavlovian-to-Instrumental Transfer","Outcome-specific Pavlovian-to-Instrumental Transfer","Amygdala","Ventral Striatum","Neuroimaging","Humans","Surveys and Questionnaires","Reward","Cues","2024-11-19",{"date":132,"type":133},"2024-11-22","ACTUAL",{"date":135,"type":133},"2024-08-05",{"date":137,"type":105},"2027-06-30",{"name":5,"class":6},1]