Ignite Creation Date:
2025-12-24 @ 11:46 PM
Ignite Modification Date:
2026-03-03 @ 6:29 AM
Study NCT ID:
NCT03969251
Status:
UNKNOWN
Last Update Posted:
2020-10-27
First Post:
2019-03-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Transcranial Magnetic Stimulation (TMS) Treatment for Alcohol Use Disorder
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000437', 'term': 'Alcoholism'}, {'id': 'D016739', 'term': 'Behavior, Addictive'}], 'ancestors': [{'id': 'D019973', 'term': 'Alcohol-Related Disorders'}, {'id': 'D019966', 'term': 'Substance-Related Disorders'}, {'id': 'D064419', 'term': 'Chemically-Induced Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D003192', 'term': 'Compulsive Behavior'}, {'id': 'D007175', 'term': 'Impulsive Behavior'}, {'id': 'D001519', 'term': 'Behavior'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D050781', 'term': 'Transcranial Magnetic Stimulation'}], 'ancestors': [{'id': 'D055909', 'term': 'Magnetic Field Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 20}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2019-07-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-10', 'completionDateStruct': {'date': '2021-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-10-25', 'studyFirstSubmitDate': '2019-03-27', 'studyFirstSubmitQcDate': '2019-05-28', 'lastUpdatePostDateStruct': {'date': '2020-10-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-05-31', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-03', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Wisconsin Card Sorting Test (WCST)', 'timeFrame': 'Up to 5 months', 'description': 'This is a neuropsychological task that measures flexibility in thinking, or "set shifting," during changing reinforcement schedules.'}, {'measure': 'Dimensional Change Card Sort Task (DCCST)', 'timeFrame': 'Up to 5 months', 'description': 'This is a neuropsychological task that measures cognitive flexibility and attention.'}, {'measure': 'Flanker Inhibitory Control and Attention Test (FICAT)', 'timeFrame': 'Up to 5 months', 'description': 'This is a neuropsychological task that measures attention and inhibitory control.'}, {'measure': 'List Sorting Working Memory Test (LSWMT)', 'timeFrame': 'Up to 5 months', 'description': 'This is a neuropsychological task that measures working memory.'}], 'secondaryOutcomes': [{'measure': 'Drinks Per Drinking Day', 'timeFrame': 'Up to 5 months', 'description': 'The investigator will use timeline follow-back to capture this drinking outcome.'}, {'measure': 'Percentage of Days of Abstinence', 'timeFrame': 'Up to 5 months', 'description': 'The investigator will use timeline follow-back to capture this drinking outcome.'}, {'measure': 'Percentage of Heavy Drinking Days', 'timeFrame': 'Up to 5 months', 'description': 'The investigator will use timeline follow-back to capture this drinking outcome.'}, {'measure': 'Alcohol Craving Questionnaire (ACQ-NOW)', 'timeFrame': 'Up to 5 months', 'description': 'This is a 47-item self-administered, multidimensional state measure of acute alcohol craving adapted from the Cocaine Craving Questionnaire. It measures the subscales of alcohol craving labeled Emotionality, Purposefulness, Compulsivity, and Expectancy.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['alcohol', 'alcohol dependence', 'addiction', 'alcohol use disorder'], 'conditions': ['Alcoholism']}, 'descriptionModule': {'briefSummary': 'This is a pilot study designed to evaluate the efficacy of High Frequency (HF) repetitive transcranial magnetic stimulation (rTMS) of the left dorsolateral prefrontal cortex (L-DLPFC) at improving cognitive flexibility in recently detoxified individuals with alcohol use disorder (AUD) compared to placebo (Sham rTMS). The total number of subjects requested to be randomized is 20. The investigator will need to screen about 40 subjects to have 20 subjects started on rTMS session at a ratio of 2 screens/1 subject randomized.', 'detailedDescription': 'This is a randomized double- blind, control study.\n\nTo test the hypothesis, the investigator propose a 2 phase design:\n\nPhase 1: 6-week trial comparing the efficacy of active high-frequency (HF) rTMS of L-DLPFC versus sham (SS) rTMS to determine if HF rTMS improves cognitive flexibility in recently detoxified alcoholics Phase 2: at the end of TMS phase, all participants will receive cognitive behavioral therapy (CBT) thus permitting participants with AUD to benefit from cognitive restructuring in CBT, and reduce alcohol cravings and drinking outcomes.\n\nThis study will recruit 20 individuals with AUD, comprising of both male and female participants, age 22 years and older interested in alcohol drinking abstinence. Participants will be recruited from the inpatient unit upon discharge after receiving a detoxification treatment and therefore will be abstinent at study entry. Prior to treatment onset and weekly throughout the course of treatment, participants will complete cognitive testing/measures, Wisconsin Card Sorting Task (WCST), Dimensional Change Card Sort Task (DCCST), Barratt Impulsiveness Scale (BIS), Flanker Inhibitory Control and Attention Test (FICAT), and List Sorting Working Memory Test (LSWMT) and self-reported craving measures, Alcohol Craving Questionnaire (ACQ-Now), and Obsessive Compulsive Drinking Scale (OCDS). The drinking timeline follow-back, and adverse events will also be assessed weekly for 8 weeks.\n\nParticipant will be randomized to either high frequency (HF) or sham repetitive transcranial magnetic stimulation (SS rTMS), which will be done 5 days per week for 6 weeks. At the end of 6 weeks, all participants will receive weekly CBT for a total of 8 weeks. Participants will return at 2 and 4 weeks for follow-up assessments.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '22 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Right handed males and females who have given written informed consent.\n* Age 22 years and above with a history of alcohol use disorder\n* Good physical health\n* Have a current diagnosis of alcohol use disorder\n* Reports at least 4 "heavy drinking days" on average in the past 30 days.\n* Have a BAC by breathalyzer equal to 0.000 when the participants signed the informed consent document\n* Six months stability on any psychotropic medications\n* Not have any unresolved legal problems that could jeopardize continuation or completion of the study.\n* Be able to provide written informed consent, able to understand written and oral instructions in English and be able to complete the questionnaires required by the protocol.\n\nExclusion Criteria:\n\nPlease contact site for additional information.'}, 'identificationModule': {'nctId': 'NCT03969251', 'briefTitle': 'Transcranial Magnetic Stimulation (TMS) Treatment for Alcohol Use Disorder', 'organization': {'class': 'OTHER', 'fullName': 'University of Virginia'}, 'officialTitle': 'Optimizing Treatment for Alcohol Use Disorder (AUD) Using Targeted Transcranial Magnetic Stimulation', 'orgStudyIdInfo': {'id': '21193'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Transcranial Magnetic Stimulation (rTMS)', 'description': 'repetitive transcranial magnetic stimulation', 'interventionNames': ['Device: Transcranial Magnetic Stimulation (rTMS)']}, {'type': 'SHAM_COMPARATOR', 'label': 'Sham (SS)', 'description': 'repetitive sham rTMS', 'interventionNames': ['Device: Sham (SS)']}], 'interventions': [{'name': 'Transcranial Magnetic Stimulation (rTMS)', 'type': 'DEVICE', 'description': 'active high frequency repetitive TMS of left Dorsolateral Prefrontal Cortex', 'armGroupLabels': ['Transcranial Magnetic Stimulation (rTMS)']}, {'name': 'Sham (SS)', 'type': 'DEVICE', 'description': 'repetitive sham rTMS', 'armGroupLabels': ['Sham (SS)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '22903', 'city': 'Charlottesville', 'state': 'Virginia', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Eva Jenkins-Mendoza', 'role': 'CONTACT', 'email': 'emj9c@virginia.edu', 'phone': '434-243-0562'}, {'name': 'Tracie Kostelac', 'role': 'CONTACT', 'email': 'tlk5d@virginia.edu', 'phone': '(434)243-0563'}], 'facility': 'UVA Center for Leading Edge Addiction Research', 'geoPoint': {'lat': 38.02931, 'lon': -78.47668}}], 'centralContacts': [{'name': 'Eva Jenkins-Mendoza', 'role': 'CONTACT', 'email': 'emj9c@virginia.edu', 'phone': '(434)243-0562'}, {'name': 'Tracie Kostelac', 'role': 'CONTACT', 'email': 'tlk5d@virginia.edu', 'phone': '(434)243-0563'}], 'overallOfficials': [{'name': 'Nassima Ait-Daoud TIouririne, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Virginia'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Nassima Ait-Daoud Tiouririne', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Associate Professor, Director of UVA Center for Leading Edge Addiction Research', 'investigatorFullName': 'Nassima Ait-Daoud Tiouririne', 'investigatorAffiliation': 'University of Virginia'}}}}