Ignite Creation Date:
2025-12-24 @ 4:46 PM
Ignite Modification Date:
2025-12-24 @ 4:46 PM
Study NCT ID:
NCT03964350
Status:
COMPLETED
Last Update Posted:
2025-01-31
First Post:
2019-05-15
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Behavior Brain Responses
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000428', 'term': 'Alcohol Drinking'}, {'id': 'D004327', 'term': 'Drinking Behavior'}], 'ancestors': [{'id': 'D001519', 'term': 'Behavior'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000431', 'term': 'Ethanol'}], 'ancestors': [{'id': 'D000438', 'term': 'Alcohols'}, {'id': 'D009930', 'term': 'Organic Chemicals'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'dewitlab@yoda.bsd.uchicago.edu', 'phone': '7737023560', 'title': 'Dr. Harriet de Wit', 'organization': 'University of Chicago'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': 'Through study completion, an average of 5 weeks', 'eventGroups': [{'id': 'EG000', 'title': 'Ethanol (0.4 g/kg)', 'description': 'Subjects will receive ethanol (0.4 g/kg) which will be administered in a gelatin vehicle.', 'otherNumAtRisk': 30, 'deathsNumAtRisk': 30, 'otherNumAffected': 0, 'seriousNumAtRisk': 30, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Placebo (Gelatin Vehicle)', 'description': 'Subjects will receive placebo of black cherry sugar-free jello.\n\nPlacebo: The placebo comparator will be individual servings of back cheery sugar-free jello.', 'otherNumAtRisk': 30, 'deathsNumAtRisk': 30, 'otherNumAffected': 0, 'seriousNumAtRisk': 30, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Ethanol (0.8 g/kg)', 'description': 'Subjects will receive ethanol (0.8 g/kg) which will be administered in a gelatin vehicle.', 'otherNumAtRisk': 30, 'deathsNumAtRisk': 30, 'otherNumAffected': 0, 'seriousNumAtRisk': 30, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change in Subjective Effects as Assessed by Score on "Feel Drug", "Feel High", "Like Drug", and "Want More" Subscales of the Drug Effects Questionnaire Across Sessions', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}, {'value': '30', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo (Gelatin)', 'description': 'Subjects gelatin vehicle.'}, {'id': 'OG001', 'title': 'Ethanol (0.4 g/kg)', 'description': 'Low dose ethanol'}, {'id': 'OG002', 'title': 'Ethanol (0.8 g/kg)', 'description': 'High dose ethanol'}], 'classes': [{'title': '"Feel Drug"', 'categories': [{'measurements': [{'value': '3.65', 'spread': '15.9', 'groupId': 'OG000'}, {'value': '45.5', 'spread': '24.9', 'groupId': 'OG001'}, {'value': '62.3', 'spread': '20.3', 'groupId': 'OG002'}]}]}, {'title': '"Feel High"', 'categories': [{'measurements': [{'value': '3.0', 'spread': '15.9', 'groupId': 'OG000'}, {'value': '33.7', 'spread': '27.4', 'groupId': 'OG001'}, {'value': '47.0', 'spread': '32.8', 'groupId': 'OG002'}]}]}, {'title': '"Like Drug"', 'categories': [{'measurements': [{'value': '10.0', 'spread': '19.7', 'groupId': 'OG000'}, {'value': '48.3', 'spread': '22.7', 'groupId': 'OG001'}, {'value': '60.9', 'spread': '22.8', 'groupId': 'OG002'}]}]}, {'title': '"Want More"', 'categories': [{'measurements': [{'value': '10.1', 'spread': '23.6', 'groupId': 'OG000'}, {'value': '39.6', 'spread': '30.4', 'groupId': 'OG001'}, {'value': '45.3', 'spread': '31.2', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '<.05', 'groupIds': ['OG000', 'OG001', 'OG002'], 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'At expected peak drug effect (30 min post drink administration)', 'description': 'Participants will complete The Drug Effects Questionnaire during the initial baseline session to determine their subjective alcohol profile. The Drug Effects Questionnaire (DEQ) is a visual analog scale questionnaire that assesses the extent to which subjects experience four subjective states : "Feel Drug", "Feel High", "Like Drug", and "Want More". All sub-scales ("Feel Drug", "Feel High", "Like Drug", and "Want More") are scored on a visual analogue scale (scroll bar on computer screen) ranging from 0-100. 100 represents the highest score for that subjective state, and the higher the score, the worse the outcome.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Placebo First (0 g/kg), Then Ethanol (0.4 g/kg), Then Ethanol (0.8 g/kg)', 'description': 'Participants who received placebo first, then low dose ethanol then high dose ethanol'}, {'id': 'FG001', 'title': 'Placebo (0 g/kg), Then Ethanol (0.8 g/kg), Then Ethanol (0.4 g/kg)', 'description': 'participants who received placebo, then high dose ethanol then low dose ethanol'}, {'id': 'FG002', 'title': 'Ethanol (0.4 g/kg), Then Ethanol (0.8 g/kg), Then Placebo (0 g/kg)', 'description': 'participants who received low dose ethanol, then high dose ethanol, then placebo'}, {'id': 'FG003', 'title': 'Ethanol First (0.8 g/kg) Then Ethanol (0.4 g/kg), Then Placebo (0 g/kg)', 'description': 'Participants who received high dose ethanol first, then low dose ethanol, then placebo'}, {'id': 'FG004', 'title': 'Ethanol First (0.8 g/kg), Then Placebo (0 g/kg), Then Ethanol (0.4 g/kg),', 'description': 'Participants who received high dose ethanol first, then placebo, then low dose ethanol'}, {'id': 'FG005', 'title': 'Ethanol First (0.4 g/kg), Then Placebo (0 g/kg), Then Ethanol (0.8 g/kg),', 'description': 'Participants who received low dose ethanol first, then placebo, then high dose ethanol'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '5'}, {'groupId': 'FG002', 'numSubjects': '3'}, {'groupId': 'FG003', 'numSubjects': '6'}, {'groupId': 'FG004', 'numSubjects': '6'}, {'groupId': 'FG005', 'numSubjects': '4'}]}, {'type': 'Sedative-like Effects', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '3'}, {'groupId': 'FG004', 'numSubjects': '3'}, {'groupId': 'FG005', 'numSubjects': '2'}]}, {'type': 'Stimulant Like Effects', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '2'}, {'groupId': 'FG003', 'numSubjects': '3'}, {'groupId': 'FG004', 'numSubjects': '3'}, {'groupId': 'FG005', 'numSubjects': '2'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '5'}, {'groupId': 'FG002', 'numSubjects': '3'}, {'groupId': 'FG003', 'numSubjects': '6'}, {'groupId': 'FG004', 'numSubjects': '6'}, {'groupId': 'FG005', 'numSubjects': '4'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '30', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Sedative-like Effects (All Study)', 'description': 'Subjects that experienced more sedative like effects'}, {'id': 'BG001', 'title': 'Stimulant-like (All Study)', 'description': 'Subjects that experienced more stimulant-like effects'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Customized', 'classes': [{'title': '>21 years of age', 'categories': [{'measurements': [{'value': '15', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '30', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'years'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '14', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '16', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '11', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '22', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '15', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '30', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Education - High School Education', 'classes': [{'categories': [{'measurements': [{'value': '15', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '30', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2022-04-11', 'size': 212558, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2022-04-11T10:02', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['EARLY_PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 30}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-05-28', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-01', 'completionDateStruct': {'date': '2020-12-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-12-05', 'studyFirstSubmitDate': '2019-05-15', 'resultsFirstSubmitDate': '2022-04-11', 'studyFirstSubmitQcDate': '2019-05-24', 'lastUpdatePostDateStruct': {'date': '2025-01-31', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2024-12-05', 'studyFirstPostDateStruct': {'date': '2019-05-28', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2025-01-31', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-12-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Subjective Effects as Assessed by Score on "Feel Drug", "Feel High", "Like Drug", and "Want More" Subscales of the Drug Effects Questionnaire Across Sessions', 'timeFrame': 'At expected peak drug effect (30 min post drink administration)', 'description': 'Participants will complete The Drug Effects Questionnaire during the initial baseline session to determine their subjective alcohol profile. The Drug Effects Questionnaire (DEQ) is a visual analog scale questionnaire that assesses the extent to which subjects experience four subjective states : "Feel Drug", "Feel High", "Like Drug", and "Want More". All sub-scales ("Feel Drug", "Feel High", "Like Drug", and "Want More") are scored on a visual analogue scale (scroll bar on computer screen) ranging from 0-100. 100 represents the highest score for that subjective state, and the higher the score, the worse the outcome.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Alcohol Drinking', 'Drinking Behavior', 'Physiological Effects of Drugs', 'Central Nervous System Depression']}, 'descriptionModule': {'briefSummary': 'To compare responses to acute oral doses of ethanol in healthy young adults who experience mainly stimulant subjective effects from the drug or mainly sedative effects.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT'], 'maximumAge': '35 Years', 'minimumAge': '21 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "* 21-35 years old\n* 4-30 alcoholic drinks per week (as reported on PHQ or TLFB)\n* No 'flushing' reaction to alcohol\n* BMI 19-26\n* High school education or greater, fluent in English\n* No night shift work\n* No current or past year Axis I psychiatric disorder including drug/alcohol dependence\n* No current psychopharmacological treatment\n* No lifetime ADHD or prescription for ADHD medication\n* No abnormal EKG, cardiovascular illness, high blood pressure\n* No medical condition or pharmacological treatment for which alcohol is contraindicated\n* Not pregnant, lactating, or planning to become pregnant\n* Smoke \\<6 cigarettes per day"}, 'identificationModule': {'nctId': 'NCT03964350', 'acronym': 'BBR', 'briefTitle': 'Behavior Brain Responses', 'organization': {'class': 'OTHER', 'fullName': 'University of Chicago'}, 'officialTitle': 'Behavior and Brain Responses to Drugs', 'orgStudyIdInfo': {'id': 'IRB19-0293'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Ethanol', 'description': 'Subjects will receive ethanol (0.4 or 0.8 g/kg) which will be administered in a gelatin vehicle.', 'interventionNames': ['Drug: Ethanol']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo (gelatin vehicle)', 'description': 'Subjects will receive placebo of black cherry sugar-free jello.', 'interventionNames': ['Other: Placebo']}], 'interventions': [{'name': 'Ethanol', 'type': 'DRUG', 'description': 'The 0.8 g/kg body weight dose of gelatin alcohol will be divided into an average of 10 servings of 0.08 g/kg each. The 0.8 g/kg dose is equivalent to 4 standard drinks, where a standard drink is defined as one 12 oz beer, one 5 oz glass of wine, or one 1.5 oz shot of 80 proof alcohol.\n\nThe 0.4 g/kg body weight dose of gelatin alcohol will be divided into an average of 5 servings of 0.08 g/kg each. The 0.4 g/kg dose is equivalent to 2 standard drinks, where a standard drink is defined as one 12 oz beer, one 5 oz glass of wine, or one 1.5 oz shot of 80 proof alcohol.', 'armGroupLabels': ['Ethanol']}, {'name': 'Placebo', 'type': 'OTHER', 'description': 'The placebo comparator will be individual servings of back cheery sugar-free jello.', 'armGroupLabels': ['Placebo (gelatin vehicle)']}]}, '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'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Chicago', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}