Ignite Creation Date:
2025-12-25 @ 4:11 AM
Ignite Modification Date:
2025-12-30 @ 11:30 PM
Study NCT ID:
NCT04642820
Status:
COMPLETED
Last Update Posted:
2025-01-09
First Post:
2020-11-18
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Drugs Brain and Behavior (DDP)
Sponsor:
Organization:
Raw JSON
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Then will return to the laboratory 72 hours later and will receive 20 mg methamphetamine.\n\nMethamphetamine: Participants will be given 20 mg of Methamphetamine.\n\nplacebo oral tablet: Participants will be given a placebo capsule that will only contain lactose.', 'otherNumAtRisk': 57, 'deathsNumAtRisk': 57, 'otherNumAffected': 0, 'seriousNumAtRisk': 57, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'MethamphetamineThen Placebo', 'description': 'Participants first receive 20 mg methamphetamine at their first session in the laboratory Then will return to the laboratory 72 hours later and will receive placebo.\n\nMethamphetamine: Participants will be given 20 mg of Methamphetamine.\n\nplacebo oral tablet: Participants will be given a placebo capsule that will only contain lactose.', 'otherNumAtRisk': 56, 'deathsNumAtRisk': 56, 'otherNumAffected': 0, 'seriousNumAtRisk': 56, '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" Sub-scales of Drug Effects Questionnaire (DEQ).', 'denoms': [{'units': 'Participants', 'counts': [{'value': '113', 'groupId': 'OG000'}, {'value': '113', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'placebo oral tablet: Participants will be given a placebo capsule that will only contain lactose.'}, {'id': 'OG001', 'title': 'Methamphetamine', 'description': 'Methamphetamine: Participants will be given 20 mg of Methamphetamine.'}], 'classes': [{'title': 'DEQ Feel - Change from baseline', 'categories': [{'measurements': [{'value': '19.2', 'spread': '21.6', 'groupId': 'OG000'}, {'value': '57.8', 'spread': '25.7', 'groupId': 'OG001'}]}]}, {'title': 'DEQ Like - Change from baseline', 'categories': [{'measurements': [{'value': '28.6', 'spread': '28.0', 'groupId': 'OG000'}, {'value': '76.3', 'spread': '26.5', 'groupId': 'OG001'}]}]}, {'title': 'DEQ Dislike - Change from baseline', 'categories': [{'measurements': [{'value': '25.2', 'spread': '28.7', 'groupId': 'OG000'}, {'value': '26.8', 'spread': '25.8', 'groupId': 'OG001'}]}]}, {'title': 'DEQ High - Change from baseline', 'categories': [{'measurements': [{'value': '13.9', 'spread': '19.4', 'groupId': 'OG000'}, {'value': '48.7', 'spread': '29.4', 'groupId': 'OG001'}]}]}, {'title': 'DEQ Want more - Change from baseline', 'categories': [{'measurements': [{'value': '22.3', 'spread': '28.1', 'groupId': 'OG000'}, {'value': '69.1', 'spread': '28.7', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '.05', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Time Frame: Day 1(baseline), 3', 'description': 'Participants will complete The Drug Effects Questionnaire during the initial baseline session to determine their subjective stimulant profile. The Dug 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 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': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Placebo Then Methamphetamine', 'description': 'Participants first receive placebo at their first session in the laboratory. Then will return to the laboratory 72 hours later and will receive 20 mg methamphetamine.\n\nMethamphetamine: Participants will be given 20 mg of Methamphetamine.\n\nplacebo oral tablet: Participants will be given a placebo capsule that will only contain lactose.'}, {'id': 'FG001', 'title': 'MethamphetamineThen Placebo', 'description': 'Participants first receive 20 mg methamphetamine at their first session in the laboratory Then will return to the laboratory 72 hours later and will receive placebo.\n\nMethamphetamine: Participants will be given 20 mg of Methamphetamine.\n\nplacebo oral tablet: Participants will be given a placebo capsule that will only contain lactose.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '69'}, {'groupId': 'FG001', 'numSubjects': '69'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '57'}, {'groupId': 'FG001', 'numSubjects': '56'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '12'}, {'groupId': 'FG001', 'numSubjects': '13'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '57', 'groupId': 'BG000'}, {'value': '56', 'groupId': 'BG001'}, {'value': '113', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Placebo Then Methamphetamine', 'description': 'Participants first receive placebo at their first session in the laboratory. Then will return to the laboratory 72 hours later and will receive 20 mg methamphetamine.\n\nMethamphetamine: Participants will be given 20 mg of Methamphetamine.\n\nplacebo oral tablet: Participants will be given a placebo capsule that will only contain lactose.'}, {'id': 'BG001', 'title': 'MethamphetamineThen Placebo', 'description': 'Participants first receive 20 mg methamphetamine at their first session in the laboratory Then will return to the laboratory 72 hours later and will receive placebo.\n\nMethamphetamine: Participants will be given 20 mg of Methamphetamine.\n\nplacebo oral tablet: Participants will be given a placebo capsule that will only contain lactose.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '24.3', 'spread': '4.3', 'groupId': 'BG000'}, {'value': '25.3', 'spread': '3.7', 'groupId': 'BG001'}, {'value': '24.8', 'spread': '4.0', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '28', 'groupId': 'BG000'}, {'value': '28', 'groupId': 'BG001'}, {'value': '56', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '29', 'groupId': 'BG000'}, {'value': '28', 'groupId': 'BG001'}, {'value': '57', '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': '6', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '20', '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': '2', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '32', 'groupId': 'BG000'}, {'value': '28', 'groupId': 'BG001'}, {'value': '60', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '18', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '57', 'groupId': 'BG000'}, {'value': '56', 'groupId': 'BG001'}, {'value': '113', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2020-11-09', 'size': 314315, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2024-12-02T15:33', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['EARLY_PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 138}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-11-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-12', 'completionDateStruct': {'date': '2024-06-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-01-06', 'studyFirstSubmitDate': '2020-11-18', 'resultsFirstSubmitDate': '2024-12-02', 'studyFirstSubmitQcDate': '2020-11-18', 'lastUpdatePostDateStruct': {'date': '2025-01-09', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2025-01-06', 'studyFirstPostDateStruct': {'date': '2020-11-24', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2025-01-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-10-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in SUbjective Effects as Assessed by Score on "Feel Drug", "Feel High", "Like Drug", and "Want More" Sub-scales of Drug Effects Questionnaire (DEQ).', 'timeFrame': 'Time Frame: Day 1(baseline), 3', 'description': 'Participants will complete The Drug Effects Questionnaire during the initial baseline session to determine their subjective stimulant profile. The Dug 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 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': ['Stimulant Use']}, 'descriptionModule': {'briefSummary': 'In this project, we will examine individual differences in the effects of a stimulant drug, methamphetamine (MA), on mesolimbic reward function using fMRI.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '35 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* BMI between 19 and 26\n* Right Handed\n* Less than 4 alcohol or caffeinated beverages a day.\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* Individuals with a history of dependence on stimulant drugs\n* Women who are pregnant or trying to become pregnant.'}, 'identificationModule': {'nctId': 'NCT04642820', 'acronym': 'DDP', 'briefTitle': 'Drugs Brain and Behavior (DDP)', 'organization': {'class': 'OTHER', 'fullName': 'University of Chicago'}, 'officialTitle': 'Drugs Brain and Behavior', 'orgStudyIdInfo': {'id': 'IRB20-0364'}, 'secondaryIdInfos': [{'id': 'R01DA002812', 'link': 'https://reporter.nih.gov/quickSearch/R01DA002812', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Placebo Then Methamphetamine', 'description': 'Participants first receive placebo at their first session in the laboratory. Then will return to the laboratory 72 hours later and will receive 20 mg methamphetamine.', 'interventionNames': ['Drug: Methamphetamine', 'Drug: placebo oral tablet']}, {'type': 'EXPERIMENTAL', 'label': 'MethamphetamineThen Placebo', 'description': 'Participants first receive 20 mg methamphetamine at their first session in the laboratory Then will return to the laboratory 72 hours later and will receive placebo.', 'interventionNames': ['Drug: Methamphetamine', 'Drug: placebo oral tablet']}], 'interventions': [{'name': 'Methamphetamine', 'type': 'DRUG', 'description': 'Participants will be given 20 mg of Methamphetamine.', 'armGroupLabels': ['MethamphetamineThen Placebo', 'Placebo Then Methamphetamine']}, {'name': 'placebo oral tablet', 'type': 'DRUG', 'description': 'Participants will be given a placebo capsule that will only contain lactose.', 'armGroupLabels': ['MethamphetamineThen Placebo', 'Placebo Then Methamphetamine']}]}, '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': 'Principal Investigator'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Chicago', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institute on Drug Abuse (NIDA)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}