Ignite Creation Date:
2025-12-24 @ 11:42 PM
Ignite Modification Date:
2025-12-25 @ 9:34 PM
Study NCT ID:
NCT05826951
Status:
COMPLETED
Last Update Posted:
2024-01-24
First Post:
2023-03-30
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Social Effects of Alcohol
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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000431', 'term': 'Ethanol'}], 'ancestors': [{'id': 'D000438', 'term': 'Alcohols'}, {'id': 'D009930', 'term': 'Organic Chemicals'}]}}, 'protocolSection': {'designModule': {'phases': ['EARLY_PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'OTHER', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 37}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-02-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-01', 'completionDateStruct': {'date': '2023-10-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-01-23', 'studyFirstSubmitDate': '2023-03-30', 'studyFirstSubmitQcDate': '2023-04-11', 'lastUpdatePostDateStruct': {'date': '2024-01-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-04-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-10-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'facial emotional responses', 'timeFrame': 'during the length of the conversation (45 min)', 'description': 'alterations in the rate of positive facial expressions during the conversation, measured by muscle action units. These will be compared between the drug and placebo sessions'}, {'measure': 'self-reported feelings of connection', 'timeFrame': 'at the end of each session (3.5 hrs post-drug administration). Changes across sessions will be assessed', 'description': 'self-other overlap measure ratings 1-7, greater ratings indicates greater feelings of connection'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Alcohol Drinking']}, 'descriptionModule': {'briefSummary': 'In this study the investigator will assess the effect of a moderate dose of alcohol on emotional responses and feelings of connection during a dyadic semi-structured social interaction', 'detailedDescription': 'The study will use a within-subject crossover design with four sessions, in which participants receive alcohol or placebo across sessions. During the four sessions, the participants will engage in a conversation with a stranger, and emotional responses and feelings of connection will be assessed.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '35 Years', 'minimumAge': '21 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* non-problem alcohol consumption of 2-20 drinks per week\n* high school diploma or equivalent\n* BMI between 19 and 26\n* verbal fluency in English\n\nExclusion Criteria:\n\n* High blood pressure\n* Any medical condition requiring regular medication\n* Individuals with a current (within the last year) DSM-IV Axis 1 diagnosis\n* Women who are pregnant or trying to become pregnant.'}, 'identificationModule': {'nctId': 'NCT05826951', 'acronym': 'SEA', 'briefTitle': 'Social Effects of Alcohol', 'organization': {'class': 'OTHER', 'fullName': 'University of Chicago'}, 'officialTitle': 'Social Effects of Alcohol', 'orgStudyIdInfo': {'id': 'IRB22-1696'}, 'secondaryIdInfos': [{'id': '5R01DA002812-35', 'link': 'https://reporter.nih.gov/quickSearch/5R01DA002812-35', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Alcohol-alcohol', 'description': 'Both conversation partners receive alcohol', 'interventionNames': ['Drug: Alcohol']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'placebo-placebo', 'description': 'Both conversation partners receive placebo', 'interventionNames': ['Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'alcohol-placebo', 'description': 'participant receives alcohol and conversation partner receives placebo', 'interventionNames': ['Drug: Alcohol']}, {'type': 'EXPERIMENTAL', 'label': 'placebo-alcohol', 'description': 'participant receives placebo and conversation partner receives alcohol', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Alcohol', 'type': 'DRUG', 'description': 'Alcohol (0.8g/kg)', 'armGroupLabels': ['Alcohol-alcohol', 'alcohol-placebo']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Placebo', 'armGroupLabels': ['placebo-alcohol', 'placebo-placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '60637', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'University of Chicago', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}], 'overallOfficials': [{'name': 'Harriet de Wit', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Chicago'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Chicago', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institutes of Health (NIH)', 'class': 'NIH'}, {'name': 'National Institute on Drug Abuse (NIDA)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}