Ignite Creation Date:
2025-12-25 @ 4:57 AM
Ignite Modification Date:
2026-07-24 @ 2:08 AM
Study NCT ID:
NCT03790618
Status:
COMPLETED
Last Update Posted:
2024-01-05
First Post:
2018-11-30
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Effect of Stimulant Drugs on Social Perception
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D008694', 'term': 'Methamphetamine'}], 'ancestors': [{'id': 'D000662', 'term': 'Amphetamines'}, {'id': 'D010627', 'term': 'Phenethylamines'}, {'id': 'D005021', 'term': 'Ethylamines'}, {'id': 'D000588', 'term': 'Amines'}, {'id': 'D009930', 'term': 'Organic Chemicals'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'dewitlab@yoda.bsd.uchicago.edu', 'phone': '7737023560', 'title': 'Harriet de Wit', 'organization': 'University of Chicago'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': 'period of time was until completion which was six weeks on average.', 'eventGroups': [{'id': 'EG000', 'title': 'Placebo', 'description': 'Subjects will attend one session during which they will receive a placebo capsule.\n\n3,4-Methylenedioxymethamphetamine: Participants will be given 0.75mg/kg of 1.5mg/kg MDMA\n\nmethamphetamine: Please see above.', 'otherNumAtRisk': 9, 'deathsNumAtRisk': 9, 'otherNumAffected': 0, 'seriousNumAtRisk': 9, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Low Dose MDMA', 'description': 'Subjects will attend one session during which they will receive 0.75mg/kg MDMA.\n\n3,4-Methylenedioxymethamphetamine: Participants will be given 0.75mg/kg of 1.5mg/kg MDMA\n\nmethamphetamine: Please see above.', 'otherNumAtRisk': 9, 'deathsNumAtRisk': 9, 'otherNumAffected': 0, 'seriousNumAtRisk': 9, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'High Dose MDMA', 'description': 'Subjects will attend one session during which they will receive 1.5mg/kg MDMA.\n\n3,4-Methylenedioxymethamphetamine: Participants will be given 0.75mg/kg of 1.5mg/kg MDMA\n\nmethamphetamine: Please see above.', 'otherNumAtRisk': 9, 'deathsNumAtRisk': 9, 'otherNumAffected': 0, 'seriousNumAtRisk': 9, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG003', 'title': 'Methamphetamine', 'description': 'Subjects will attend one session during which they will receive 20mg methamphetamine.\n\n3,4-Methylenedioxymethamphetamine: Participants will be given 0.75mg/kg of 1.5mg/kg MDMA\n\nmethamphetamine: Please see above.', 'otherNumAtRisk': 9, 'deathsNumAtRisk': 9, 'otherNumAffected': 0, 'seriousNumAtRisk': 9, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Responses to Affective Touch', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Subjects will attend one session during which they will receive a placebo capsule.\n\n3,4-Methylenedioxymethamphetamine: Participants will be given 0.75mg/kg of 1.5mg/kg MDMA\n\nmethamphetamine: Please see above.'}, {'id': 'OG001', 'title': 'Low Dose MDMA', 'description': 'Subjects will attend one session during which they will receive 0.75mg/kg MDMA.\n\n3,4-Methylenedioxymethamphetamine: Participants will be given 0.75mg/kg of 1.5mg/kg MDMA\n\nmethamphetamine: Please see above.'}, {'id': 'OG002', 'title': 'High Dose MDMA', 'description': 'Subjects will attend one session during which they will receive 1.5mg/kg MDMA.\n\n3,4-Methylenedioxymethamphetamine: Participants will be given 0.75mg/kg of 1.5mg/kg MDMA\n\nmethamphetamine: Please see above.'}, {'id': 'OG003', 'title': 'Methamphetamine', 'description': 'Subjects will attend one session during which they will receive 20mg methamphetamine.\n\n3,4-Methylenedioxymethamphetamine: Participants will be given 0.75mg/kg of 1.5mg/kg MDMA\n\nmethamphetamine: Please see above.'}], 'classes': [{'categories': [{'measurements': [{'value': '-1.24', 'spread': '3.22', 'groupId': 'OG000'}, {'value': '0.12', 'spread': '3.14', 'groupId': 'OG001'}, {'value': '0.19', 'spread': '2.25', 'groupId': 'OG002'}, {'value': '0.25', 'spread': '2.68', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'End of study (time 0 and approximately six weeks later)', 'description': 'Participants will complete an affective touch task during which time they will rate pleasantness of touch on a likert scale of 1-7, with higher scores indicating greater ratings of pleasantness', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Placebo', 'description': 'Subjects will attend one session during which they will receive a placebo capsule.\n\n3,4-Methylenedioxymethamphetamine: Participants will be given 0.75mg/kg of 1.5mg/kg MDMA\n\nmethamphetamine: Please see above.'}, {'id': 'FG001', 'title': 'Low Dose MDMA', 'description': 'Subjects will attend one session during which they will receive 0.75mg/kg MDMA.\n\n3,4-Methylenedioxymethamphetamine: Participants will be given 0.75mg/kg of 1.5mg/kg MDMA\n\nmethamphetamine: Please see above.'}, {'id': 'FG002', 'title': 'High Dose MDMA', 'description': 'Subjects will attend one session during which they will receive 1.5mg/kg MDMA.\n\n3,4-Methylenedioxymethamphetamine: Participants will be given 0.75mg/kg of 1.5mg/kg MDMA\n\nmethamphetamine: Please see above.'}, {'id': 'FG003', 'title': 'Methamphetamine', 'description': 'Subjects will attend one session during which they will receive 20mg methamphetamine.\n\n3,4-Methylenedioxymethamphetamine: Participants will be given 0.75mg/kg of 1.5mg/kg MDMA\n\nmethamphetamine: Please see above.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '9'}, {'groupId': 'FG001', 'numSubjects': '9'}, {'groupId': 'FG002', 'numSubjects': '9'}, {'groupId': 'FG003', 'numSubjects': '9'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '9'}, {'groupId': 'FG001', 'numSubjects': '9'}, {'groupId': 'FG002', 'numSubjects': '9'}, {'groupId': 'FG003', 'numSubjects': '9'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}, {'value': '9', 'groupId': 'BG003'}, {'value': '36', 'groupId': 'BG004'}]}], 'groups': [{'id': 'BG000', 'title': 'Placebo', 'description': 'Subjects will attend one session during which they will receive a placebo capsule.\n\n3,4-Methylenedioxymethamphetamine: Participants will be given 0.75mg/kg of 1.5mg/kg MDMA\n\nmethamphetamine: Please see above.'}, {'id': 'BG001', 'title': 'Low Dose MDMA', 'description': 'Subjects will attend one session during which they will receive 0.75mg/kg MDMA.\n\n3,4-Methylenedioxymethamphetamine: Participants will be given 0.75mg/kg of 1.5mg/kg MDMA\n\nmethamphetamine: Please see above.'}, {'id': 'BG002', 'title': 'High Dose MDMA', 'description': 'Subjects will attend one session during which they will receive 1.5mg/kg MDMA.\n\n3,4-Methylenedioxymethamphetamine: Participants will be given 0.75mg/kg of 1.5mg/kg MDMA\n\nmethamphetamine: Please see above.'}, {'id': 'BG003', 'title': 'Methamphetamine', 'description': 'Subjects will attend one session during which they will receive 20mg methamphetamine.\n\n3,4-Methylenedioxymethamphetamine: Participants will be given 0.75mg/kg of 1.5mg/kg MDMA\n\nmethamphetamine: Please see above.'}, {'id': 'BG004', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}, {'value': '9', 'groupId': 'BG003'}, {'value': '36', 'groupId': 'BG004'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}, {'value': '5', 'groupId': 'BG003'}, {'value': '20', 'groupId': 'BG004'}]}, {'title': 'Male', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}, {'value': '4', 'groupId': 'BG003'}, {'value': '16', 'groupId': 'BG004'}]}]}], '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'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}, {'title': 'Asian', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '4', 'groupId': 'BG004'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}, {'title': 'Black or African American', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}, {'value': '8', 'groupId': 'BG004'}]}, {'title': 'White', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}, {'value': '5', 'groupId': 'BG003'}, {'value': '20', 'groupId': 'BG004'}]}, {'title': 'More than one race', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '4', 'groupId': 'BG004'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}, {'value': '9', 'groupId': 'BG003'}, {'value': '36', 'groupId': 'BG004'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Education - High School Education', 'classes': [{'categories': [{'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}, {'value': '9', 'groupId': 'BG003'}, {'value': '36', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2015-01-08', 'size': 268870, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2022-06-14T10:39', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 36}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-06-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-03', 'completionDateStruct': {'date': '2018-08-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-03-29', 'studyFirstSubmitDate': '2018-11-30', 'resultsFirstSubmitDate': '2022-06-14', 'studyFirstSubmitQcDate': '2018-12-28', 'lastUpdatePostDateStruct': {'date': '2024-01-05', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2023-03-29', 'studyFirstPostDateStruct': {'date': '2018-12-31', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2024-01-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-08-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Responses to Affective Touch', 'timeFrame': 'End of study (time 0 and approximately six weeks later)', 'description': 'Participants will complete an affective touch task during which time they will rate pleasantness of touch on a likert scale of 1-7, with higher scores indicating greater ratings of pleasantness'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Healthy', "MDMA ('Ecstasy')"]}, 'referencesModule': {'references': [{'pmid': '38279662', 'type': 'DERIVED', 'citation': 'Bershad AK, Hsu DT, de Wit H. MDMA enhances positive affective responses to social feedback. J Psychopharmacol. 2024 Mar;38(3):297-304. doi: 10.1177/02698811231224153. Epub 2024 Jan 27.'}]}, 'descriptionModule': {'briefSummary': 'The study will improve our understanding of the "prosocial" effects of ± 3,4-Methylenedioxymethamphetamine (MDMA), relative to a prototypical stimulant, methamphetamine (MA). The investigators seek to characterize the "uniquely social" effects of MDMA.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '35 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* High school degree\n* English fluency\n* Healthy\n* Has used MDMA\n\nExclusion Criteria:\n\n* Pregnant or trying to become pregnant\n* Any medical or psychiatry condition'}, 'identificationModule': {'nctId': 'NCT03790618', 'acronym': 'ESP', 'briefTitle': 'Effect of Stimulant Drugs on Social Perception', 'organization': {'class': 'OTHER', 'fullName': 'University of Chicago'}, 'officialTitle': 'Effect of Stimulant Drugs on Social Perception', 'orgStudyIdInfo': {'id': 'IRB15-780'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Subjects will attend one session during which they will receive a placebo capsule.', 'interventionNames': ['Drug: 3,4-Methylenedioxymethamphetamine', 'Drug: methamphetamine']}, {'type': 'EXPERIMENTAL', 'label': 'Low dose MDMA', 'description': 'Subjects will attend one session during which they will receive 0.75mg/kg MDMA.', 'interventionNames': ['Drug: 3,4-Methylenedioxymethamphetamine', 'Drug: methamphetamine']}, {'type': 'EXPERIMENTAL', 'label': 'High dose MDMA', 'description': 'Subjects will attend one session during which they will receive 1.5mg/kg MDMA.', 'interventionNames': ['Drug: 3,4-Methylenedioxymethamphetamine', 'Drug: methamphetamine']}, {'type': 'EXPERIMENTAL', 'label': 'Methamphetamine', 'description': 'Subjects will attend one session during which they will receive 20mg methamphetamine.', 'interventionNames': ['Drug: 3,4-Methylenedioxymethamphetamine', 'Drug: methamphetamine']}], 'interventions': [{'name': '3,4-Methylenedioxymethamphetamine', 'type': 'DRUG', 'description': 'Participants will be given 0.75mg/kg of 1.5mg/kg MDMA', 'armGroupLabels': ['High dose MDMA', 'Low dose MDMA', 'Methamphetamine', 'Placebo']}, {'name': 'methamphetamine', 'type': 'DRUG', 'description': 'Please see above.', 'armGroupLabels': ['High dose MDMA', 'Low dose MDMA', 'Methamphetamine', 'Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '60637', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'University of Chicago', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Chicago', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}