[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100431377":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":31,"centralContacts":35,"locations":40,"responsibleParty":42,"collaborators":40,"id":45,"slug":46,"hasResults":47,"nctId":48,"briefTitle":49,"officialTitle":50,"acronym":40,"eligibilityCriteria":51,"healthyVolunteers":47,"sex":52,"minAge":53,"maxAge":54,"enrollmentInfo":55,"targetDuration":40,"studyType":58,"phases":59,"briefSummary":61,"conditions":62,"keywords":70,"overallStatus":77,"whyStopped":40,"lastUpdateSubmitDate":78,"lastUpdatePostDateStruct":79,"startDateStruct":82,"completionDateStruct":84,"leadSponsor":86,"locationsCount":40},{"fullName":5,"class":6},"ITAB - Institute for Advanced Biomedical Technologies","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Active tDCS","ACTIVE_COMPARATOR","The intervention will be the stimulation with transcranial Direct Current Stimulation (tDCS). Each patient will undergo a 20 minutes session with anode placed on the right Dorso-Lateral Prefrontal Cortex (RDLPFC) and the cathode on the left DLPFC (LDLPFC); the tDCS will administrate a 1 mA stimulation. During the intensive treatment phase participant will undergo one stimulation\u002Fday for 5 consecutive days. After this, participants will receive one stimulation per week for 3 months with the same parameters. Device: tDCS device (E.M.S. Electromedical Systems, Bologna, Italy) with a maximum output of 5 mA and administered by two 25-cm2 sponge electrodes of rectangular shape.",[13],"Device: Active transcranial Direct Current Stimulation",{"label":15,"type":16,"description":17,"interventionNames":18},"Sham tDCS","SHAM_COMPARATOR","The intervention will be the stimulation with sham transcranial Direct Current Stimulation (sham tDCS). The device will be set by staff member not involved with data collection analysis to ensure the blinding of assessors. The device will be set to give a weak amperage for the first and the last 20 second of stimulation to ensure the blinding of participant giving them a similar sensation experienced by the active tDCS participants without stimulate brain tissues. Device: tDCS device (E.M.S. Electromedical Systems, Bologna, Italy) with a maximum output of 5 mA and administered by two 25-cm2 sponge electrodes of rectangular shape.",[19],"Device: Sham transcranial Direct Current Stimulation",[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DEVICE","Active transcranial Direct Current Stimulation","tDCS is a non-invasive brain stimulation technique. The investigators will use a BrainSTIM (EMS, Bologna, Italy)",[9],[9],{"type":22,"name":28,"description":24,"armGroupLabels":29,"otherNames":30},"Sham transcranial Direct Current Stimulation",[15],[15],[32],{"name":33,"affiliation":5,"role":34},"Massimo di Giannantonio, MD","PRINCIPAL_INVESTIGATOR",[36],{"name":37,"role":38,"phone":39,"phoneExt":40,"email":41},"Mauro Pettorruso, MD, PhD","CONTACT","+39 0871 355 6901",null,"mauro.pettorruso@unich.it",{"type":34,"investigatorFullName":43,"investigatorTitle":44,"investigatorAffiliation":5,"oldNameTitle":40,"oldOrganization":40},"Mauro Pettorruso","Junior Researcher","100431377","neurobiological-effects-of-transcranial-direct-current-stimulation-treatment-in-alcohol-use-disorder-100431377",false,"NCT04897295","Neurobiological Effects of Transcranial Direct Current Stimulation Treatment in Alcohol Use Disorder","Neurobiological Effects of Transcranial Direct Current Stimulation Treatment in Alcohol Use Disorder: a Sham-controlled Trial.","Inclusion Criteria:\n\n* diagnosis of Alcohol Use Disorder (at least 12 months);\n* drug free\u002Fstable psychopharmacological therapy (one month), with the exception of guidelines treatments for alcoholic abstinence (treatment-as-usual);\n* any assumption of substances for at least 48 hours.\n\nExclusion Criteria:\n\n* presence of organic pathologies (capable of interfering with the safety of the procedure) in comorbidities;\n* presence of intellectual disability;\n* history of epileptic seizures (also in first degree relatives);\n* score\\> 12 on the Young Mania Rating Scale (Y-MRS).","ALL","18 Years","65 Years",{"count":56,"type":57},30,"ESTIMATED","INTERVENTIONAL",[60],"NA","Background: Alcohol Use Disorder (AUD) is a complex psychiatric disorder, involving several brain areas and neurocircuits. Transcranial Direct Current Stimulation (tDCS) allows to stimulate superficial areas of brain using a weak electrical current. Preliminary data suggest that tDCS may reduce alcohol craving and consumption.\n\nObjectives: The main outcome is to test if tDCS can reduce alcohol craving and use and to assess the changes in BDNF and pro-BDNF levels. Secondary outcomes are the assessment of other psychiatric dimensions (mood, behavioral and cognitive alterations) associated with prolonged alcohol use.\n\nEligibility: Healthy, right-handed adults ages 18-65 who do have AUD (moderate to severe).\n\nDesign: This is a randomized, double-blind, sham-controlled study with three phases: 1) a tDCS intensive treatment phase; 2) follow-up with weekly tDCS stimulation; 3) follow-up without tDCS stimulation.\n\nParticipants will be screened with:\n\n* Psychometric Scales\n* Medical history\n* Physical exam\n* Urine tests and breathalyzer\n* After being enrolled, baseline behavioral and laboratory data will be collected. In particular, participants will undergo:\n* Psychometric Scales\n* Venous blood sample (BDNF\u002FproBDNF levels)\n\nParticipants will be randomized to real or sham tDCS arm. The stimulation will be delivered daily for five days during the first week (intensive treatment phase) and then weekly for 3 months (follow-up with stimulation). During this period patient will be tested with a behavioral and psychometric evaluation.Therefore, participants will receive 3 follow-up monthly visits without tDCS stimulation, in which behavioral and psychometric data will be collected.\n\nTreatment includes:\n\n* tDCS: The tDCS will be delivered with a stimulator connected to two sponge electrodes, soaked in a saline solution. The stimulation will be administered at a current intensity of approximately 1 mA, for the duration of 20 minutes. The anode will be placed on the right DLPFC, the cathode on the contralateral cortical area.\n* BDNF\u002FproBDNF levels: A venous blood sample will be collected before the first stimulation and after the last stimulation of the intensive-stimulation period (first week). The blood sample will be centrifuged within 20 minutes of sampling at 1000 × g for 15 minutes. Then, the serum will be aliquoted and stored at -80 ° C until analysis.\n* Repeat of screening tests and questionnaires\n* Urine toxicological screen and breathalyzer",[63,64,65,66,67,68,69],"Alcohol Use Disorder (AUD)","Alcohol Abuse","Alcohol Dependence","Alcohol-Related Disorders","Drug Abuse","Substance Use Disorders","Mental Disorder",[71,72,73,74,75,76],"Alcohol Use Disorder","transcranial Direct Current Stimulation","Non-Invasive Brain Stimulation","Craving","Brain Derived Neurotrophic Factor","Pro-Brain Derived Neurotrophic Factor","NOT_YET_RECRUITING","2021-10-25",{"date":80,"type":81},"2021-10-26","ACTUAL",{"date":83,"type":57},"2021-12-01",{"date":85,"type":57},"2026-11-30",{"name":5,"class":6}]