Ignite Creation Date:
2025-12-25 @ 3:27 AM
Ignite Modification Date:
2026-02-21 @ 4:21 AM
Study NCT ID:
NCT03691805
Status:
COMPLETED
Last Update Posted:
2020-12-30
First Post:
2018-09-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Transcranial Direct Current Stimulation - Tobacco Use Disorder
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D014029', 'term': 'Tobacco Use Disorder'}], 'ancestors': [{'id': 'D019966', 'term': 'Substance-Related Disorders'}, {'id': 'D064419', 'term': 'Chemically-Induced Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D065908', 'term': 'Transcranial Direct Current Stimulation'}], 'ancestors': [{'id': 'D004599', 'term': 'Electric Stimulation Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D003295', 'term': 'Convulsive Therapy'}, {'id': 'D013000', 'term': 'Psychiatric Somatic Therapies'}, {'id': 'D004191', 'term': 'Behavioral Disciplines and Activities'}, {'id': 'D004597', 'term': 'Electroshock'}, {'id': 'D011580', 'term': 'Psychological Techniques'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT'], 'maskingDescription': 'Participants will be blinded as to their assigned study arm.'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Half of the participants will receive transcranial direct current stimulation, while the others will receive sham stimulation.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 44}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-10-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-12', 'completionDateStruct': {'date': '2020-02-18', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-12-29', 'studyFirstSubmitDate': '2018-09-28', 'studyFirstSubmitQcDate': '2018-09-28', 'lastUpdatePostDateStruct': {'date': '2020-12-30', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-10-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-02-18', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Reduced number of cigarettes smoked', 'timeFrame': 'First assessment on Day 1, second on Day 8', 'description': 'Smoking habits will be assessed via interview at the beginning of the study and after a follow-up period of three days. Number of cigarettes smoked will be compared longitudinally and between groups.'}], 'secondaryOutcomes': [{'measure': 'Reduced Carving', 'timeFrame': 'First assessment on Day 1, second on Day 5, third on Day 8', 'description': 'Craving will be assessed using visual analog scales on the first and fifth day of the study as well as in the follow-up interview. Ratings will be compared longitudinally and between groups..'}, {'measure': 'Increased inhibitory control', 'timeFrame': 'First and second testing on Day 1, third testing on Day 5', 'description': 'Inhibitory control will be assessed in neuropsychological tests (Go / No-Go, Stop-Signal Task) before and after the first stimulation session and after the fifth session. Results will be compared longitudinally and between groups.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Transcranial Direct Current Stimulation'], 'conditions': ['Tobacco Use Disorder']}, 'referencesModule': {'references': [{'pmid': '34198135', 'type': 'DERIVED', 'citation': 'Muller T, Shevchenko Y, Gerhardt S, Kiefer F, Vollstadt-Klein S. The influence of perceived stress and self-control on efficacy of repeated transcranial direct current stimulation in non-treatment-seeking smokers. Drug Alcohol Depend. 2021 Sep 1;226:108861. doi: 10.1016/j.drugalcdep.2021.108861. Epub 2021 Jun 24.'}]}, 'descriptionModule': {'briefSummary': "This study aims to detect how transcranial direct current stimulation (tDCS) affects smokers' inhibitory control, craving and consumption of tobacco goods.", 'detailedDescription': 'Participating smokers are to receive anodal transcranial direct current stimulation of the right dorsolateral prefrontal cortex (rDLPFC) for 20 minutes on five consecutive days. Neuropsychological tests on inhibitory control and interviews on smoking habits and craving will be applied before and after the first stimulation as well as after the fifth stimulation.\n\nAfter a follow-up period of three days, smoking behaviour will be assessed in a telephone interview.\n\nChanges in inhibitory control and smoking behaviour will be compared between an active and a sham stimulation group.This way the effects of transcranial direct current stimulation on tobacco use disorder are to be clarified.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* tobacco use disorder\n* normal or correctable eyesight\n* sufficient ability to communicate with the investigators, to answer questions in oral and written form\n* fully informed consent\n* written informed consent\n\nExclusion Criteria:\n\n* withdrawal of the declaration of consent\n* exclusion criteria for tDCS (metal implants in the head, acute eczema, known epilepsy)\n* severe internal, neurological or psychiatric comorbidity\n* pharmacotherapy with psychoactive substances within the last 14 days\n* axis-I disorder according to ICD-10 and DSM 5 (except tobacco use disorder)\n* positive urin drug screening (cannabis, amphetamine, opiates, benzodiazepines, cocaine)\n* pregnancy'}, 'identificationModule': {'nctId': 'NCT03691805', 'briefTitle': 'Transcranial Direct Current Stimulation - Tobacco Use Disorder', 'organization': {'class': 'OTHER', 'fullName': 'Central Institute of Mental Health, Mannheim'}, 'officialTitle': 'Transcranial Direct Current Stimulation as an Intervention in Tobacco Use Disorder: Effects on Consumption and Craving', 'orgStudyIdInfo': {'id': 'tDCS-TUD'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'anodal tDCS over rDLPFC', 'description': 'Participants will receive anodal tDCS (transcranial direct current stimulation) of the right dorsolateral prefrontal Cortex (DLPFC).', 'interventionNames': ['Device: tDCS']}, {'type': 'SHAM_COMPARATOR', 'label': 'sham tDCS', 'description': 'Participants will receive sham tDCS (transcranial direct current stimulation) of the DLPFC.', 'interventionNames': ['Device: Sham tDCS']}], 'interventions': [{'name': 'tDCS', 'type': 'DEVICE', 'otherNames': ['sooma medical', 'transcranial direct current stimulation'], 'description': 'The participants will receive anodal tDCS (transcranial direct current stimulation) of the right dorsolateral prefrontal cortex for 20 minutes on five consecutive days.', 'armGroupLabels': ['anodal tDCS over rDLPFC']}, {'name': 'Sham tDCS', 'type': 'DEVICE', 'description': 'The participants will receive sham tDCS (transcranial direct current stimulation) of the dorsolateral prefrontal cortex for 20 minutes on five consecutive days.', 'armGroupLabels': ['sham tDCS']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Mannheim', 'country': 'Germany', 'facility': 'Klinik für Abhängiges Verhalten, Zentralinstitut für Seelische Gesundheit', 'geoPoint': {'lat': 49.4891, 'lon': 8.46694}}], 'overallOfficials': [{'name': 'Sabine Vollstädt-Klein', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'ZI Mannheim'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Central Institute of Mental Health, Mannheim', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}