Ignite Creation Date:
2025-12-24 @ 9:46 PM
Ignite Modification Date:
2025-12-28 @ 5:39 AM
Study NCT ID:
NCT05675332
Status:
RECRUITING
Last Update Posted:
2025-04-13
First Post:
2022-12-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effects of Stereotype Threat on Impulsivity and Its Relation to Alcohol Use in African Americans: An fMRI Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000428', 'term': 'Alcohol Drinking'}], 'ancestors': [{'id': 'D004327', 'term': 'Drinking Behavior'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 280}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-12-09', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-04', 'completionDateStruct': {'date': '2026-01-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-04-10', 'studyFirstSubmitDate': '2022-12-22', 'studyFirstSubmitQcDate': '2022-12-22', 'lastUpdatePostDateStruct': {'date': '2025-04-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-01-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-01-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Blood oxygen-level dependent (BOLD) signal', 'timeFrame': 'Baseline', 'description': 'Blood oxygen-level dependent (BOLD) signal in brain regions of interest (ROI) measured using fMRI'}, {'measure': 'Resting-state functional connectivity in brain regions', 'timeFrame': 'Baseline', 'description': 'Resting-state functional connectivity - brain activity measured using fMRI'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Alcohol Drinking']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to investigate the behavioral and neural correlates of stress exposure. Results from this study will enrich the understanding of how sociocultural, behavioral, and neural factors combine to influence alcohol use.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '35 Years', 'minimumAge': '21 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Between 21 and 35 years of age (inclusive);\n* Fluent in English;\n* Right-handed\n\nExclusion Criteria:\n\n* Younger than 21 years of age;\n* Left-handed'}, 'identificationModule': {'nctId': 'NCT05675332', 'briefTitle': 'Effects of Stereotype Threat on Impulsivity and Its Relation to Alcohol Use in African Americans: An fMRI Study', 'organization': {'class': 'OTHER', 'fullName': 'Icahn School of Medicine at Mount Sinai'}, 'officialTitle': 'Effects of Stereotype Threat on Impulsivity and Its Relation to Alcohol Use in African Americans: An fMRI Study', 'orgStudyIdInfo': {'id': 'GCO 19-0250'}, 'secondaryIdInfos': [{'id': 'R01AA028023', 'link': 'https://reporter.nih.gov/quickSearch/R01AA028023', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'no stress exposure', 'description': 'no threat stress', 'interventionNames': ['Behavioral: Task-based behavioral intervention']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'stress exposure', 'description': 'exposure to stress threat', 'interventionNames': ['Behavioral: Task-based behavioral intervention']}], 'interventions': [{'name': 'Task-based behavioral intervention', 'type': 'BEHAVIORAL', 'description': 'Brief behavioral intervention is absent of stressors.', 'armGroupLabels': ['no stress exposure']}, {'name': 'Task-based behavioral intervention', 'type': 'BEHAVIORAL', 'description': 'Brief behavioral intervention involves interacting with common everyday types of stress.', 'armGroupLabels': ['stress exposure']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10029', 'city': 'New York', 'state': 'New York', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Uraina Clark, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Icahn School of Medicine at Mount Sinai', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}], 'centralContacts': [{'name': 'Shivani Doshi', 'role': 'CONTACT', 'email': 'shivani.doshi@mssm.edu', 'phone': '212-241-6582'}], 'overallOfficials': [{'name': 'Uraina Clark, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Icahn School of Medicine at Mount Sinai'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'There is no plan to share IPD'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Icahn School of Medicine at Mount Sinai', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institute on Alcohol Abuse and Alcoholism (NIAAA)', 'class': 'NIH'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Uraina S Clark', 'investigatorAffiliation': 'Icahn School of Medicine at Mount Sinai'}}}}