Ignite Creation Date:
2025-12-24 @ 11:09 PM
Ignite Modification Date:
2025-12-25 @ 8:43 PM
Study NCT ID:
NCT03495869
Status:
COMPLETED
Last Update Posted:
2021-08-04
First Post:
2018-03-29
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Feasibility and Validation of a Standard Phenotyping Assessment Battery
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009293', 'term': 'Opioid-Related Disorders'}], 'ancestors': [{'id': 'D000079524', 'term': 'Narcotic-Related Disorders'}, {'id': 'D019966', 'term': 'Substance-Related Disorders'}, {'id': 'D064419', 'term': 'Chemically-Induced Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'lori.keysermarcus@vcuhealth.org', 'phone': '(804) 828-4164', 'title': 'Lori Keyser-Marcus, PhD', 'organization': 'Virginia Commonwealth University'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': '1 month', 'description': 'AE form/log', 'eventGroups': [{'id': 'EG000', 'title': 'Individuals With Cocaine Use Disorder', 'description': 'This group will consist of individuals who are determined to have DSM5 diagnosis of Cocaine Use Disorder (n=50).\n\nIndividuals will be recruited from an existing registry (VCU IRB HMHM20000294, Keyser-Marcus, PI)', 'otherNumAtRisk': 50, 'deathsNumAtRisk': 50, 'otherNumAffected': 0, 'seriousNumAtRisk': 50, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Individuals With Opioid Use Disorder', 'description': 'This group will consist of individuals who are determined to have DSM5 diagnosis of Opioid Use Disorder (n=200).', 'otherNumAtRisk': 97, 'deathsNumAtRisk': 97, 'otherNumAffected': 0, 'seriousNumAtRisk': 97, 'deathsNumAffected': 0, 'seriousNumAffected': 1}, {'id': 'EG002', 'title': 'Individuals With Marijuana Use Disorder', 'description': 'This group will consist of individuals who are determined to have DSM5 diagnosis of Marijuana Use Disorder (n=50).', 'otherNumAtRisk': 51, 'deathsNumAtRisk': 51, 'otherNumAffected': 0, 'seriousNumAtRisk': 51, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG003', 'title': 'Healthy Controls', 'description': 'This group will consist of individuals who are determined to be non-drug using healthy controls (n=100).', 'otherNumAtRisk': 108, 'deathsNumAtRisk': 108, 'otherNumAffected': 0, 'seriousNumAtRisk': 108, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'seriousEvents': [{'term': 'hospitalization', 'notes': 'Participant was hospitalized to treat cellulitis of a vein that occurred as a result of plasma donation the day prior to study enrollment.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 97, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 51, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 108, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Retention', 'denoms': [{'units': 'Participants', 'counts': [{'value': '54', 'groupId': 'OG000'}, {'value': '124', 'groupId': 'OG001'}, {'value': '61', 'groupId': 'OG002'}, {'value': '129', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Individuals With Cocaine Use Disorder', 'description': 'This group will consist of individuals who are determined to have DSM5 diagnosis of Cocaine Use Disorder (n=50).\n\nIndividuals will be recruited from an existing registry (VCU IRB HMHM20000294, Keyser-Marcus, PI)'}, {'id': 'OG001', 'title': 'Individuals With Opioid Use Disorder', 'description': 'This group will consist of individuals who are determined to have DSM5 diagnosis of Opioid Use Disorder (n=200).'}, {'id': 'OG002', 'title': 'Individuals With Marijuana Use Disorder', 'description': 'This group will consist of individuals who are determined to have DSM5 diagnosis of Marijuana Use Disorder (n=50).'}, {'id': 'OG003', 'title': 'Healthy Controls', 'description': 'This group will consist of individuals who are determined to be non-drug using healthy controls (n=100).'}], 'classes': [{'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}, {'value': '21', 'groupId': 'OG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '1 month', 'description': 'Number of dropouts', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who signed consent forms and screened eligible were included in the analysis for this outcome variable.'}, {'type': 'SECONDARY', 'title': 'Time to Complete Battery', 'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'OG000'}, {'value': '97', 'groupId': 'OG001'}, {'value': '51', 'groupId': 'OG002'}, {'value': '108', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Individuals With Cocaine Use Disorder', 'description': 'This group will consist of individuals who are determined to have DSM5 diagnosis of Cocaine Use Disorder (n=50).\n\nIndividuals will be recruited from an existing registry (VCU IRB HMHM20000294, Keyser-Marcus, PI)'}, {'id': 'OG001', 'title': 'Individuals With Opioid Use Disorder', 'description': 'This group will consist of individuals who are determined to have DSM5 diagnosis of Opioid Use Disorder (n=200).'}, {'id': 'OG002', 'title': 'Individuals With Marijuana Use Disorder', 'description': 'This group will consist of individuals who are determined to have DSM5 diagnosis of Marijuana Use Disorder (n=50).'}, {'id': 'OG003', 'title': 'Healthy Controls', 'description': 'This group will consist of individuals who are determined to be non-drug using healthy controls (n=100).'}], 'classes': [{'title': 'Time to complete Phenotyping assessment battery', 'categories': [{'measurements': [{'value': '73.86', 'spread': '15.77', 'groupId': 'OG000'}, {'value': '68.53', 'spread': '16.16', 'groupId': 'OG001'}, {'value': '59.76', 'spread': '10.19', 'groupId': 'OG002'}, {'value': '61.04', 'spread': '17.66', 'groupId': 'OG003'}]}]}, {'title': 'Time to complete battery of Platform Instruments', 'categories': [{'measurements': [{'value': '96.97', 'spread': '38.07', 'groupId': 'OG000'}, {'value': '91.24', 'spread': '32.83', 'groupId': 'OG001'}, {'value': '75.08', 'spread': '28.67', 'groupId': 'OG002'}, {'value': '68.53', 'spread': '24.52', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': '5 hours', 'description': 'Time to complete the assessment batteries will also be recorded for each task and each participant.', 'unitOfMeasure': 'Minutes', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Non-completers of the Battery and Platform Instruments', 'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'OG000'}, {'value': '97', 'groupId': 'OG001'}, {'value': '51', 'groupId': 'OG002'}, {'value': '108', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Individuals With Cocaine Use Disorder', 'description': 'This group will consist of individuals who are determined to have DSM5 diagnosis of Cocaine Use Disorder (n=50).\n\nIndividuals will be recruited from an existing registry (VCU IRB HMHM20000294, Keyser-Marcus, PI)'}, {'id': 'OG001', 'title': 'Individuals With Opioid Use Disorder', 'description': 'This group will consist of individuals who are determined to have DSM5 diagnosis of Opioid Use Disorder (n=200).'}, {'id': 'OG002', 'title': 'Individuals With Marijuana Use Disorder', 'description': 'This group will consist of individuals who are determined to have DSM5 diagnosis of Marijuana Use Disorder (n=50).'}, {'id': 'OG003', 'title': 'Healthy Controls', 'description': 'This group will consist of individuals who are determined to be non-drug using healthy controls (n=100).'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '5 hours', 'description': 'Number of study completers who did not complete the full battery and platform instruments', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Performance on Measures of Cognition Across Conditions', 'timeFrame': '5 hours', 'description': 'Performance (time to complete)\n\n#correct) on behavioral tasks which examine cognitive functioning (e.g., Backwards digit span, and stop signal reaction task)', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Performance on Measures of Reward Processing Across Conditions', 'timeFrame': '5 hours', 'description': 'Performance (time to complete)\n\n#correct) on behavioral tasks which examine Reward processing (e.g., hypothetical purchase task) and subscale and total scale scores on self-report measures of reward processing (SUPP-S)', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Performance on Measures of Negative Emotionality Across Conditions', 'timeFrame': '5 hours', 'description': 'Performance (time to complete)\n\n#correct) on behavioral tasks which examine Negative Emotionality (Emotional go/nogo) and subscale and total scale scores on self-report measures of Negative Emotionality (Buss Perry Aggression)', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Self-report on Measure of Interoception Across Conditions', 'timeFrame': '5 hours', 'description': 'Performance (time to complete)', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Self-report on Measure of Metacognition Across Conditions', 'timeFrame': '5 hours', 'description': 'Performance (time to complete)', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Self-report on Measure of Sleep Quality Across Conditions', 'timeFrame': '5 hours', 'description': 'Performance (time to complete)', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Between-group Differences in Brain Connectivity as Measured by Spectral Dynamic Causal Modeling (DCM) and Deterministic Dynamic Causal Modeling', 'timeFrame': '1 month', 'description': 'Between-group differences in brain connectivity as measured by Spectral dynamic causal modeling (DCM) and Deterministic dynamic causal modeling', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Individuals With Cocaine Use Disorder', 'description': 'This group will consist of individuals who are determined to have DSM5 diagnosis of Cocaine Use Disorder (n=50).\n\nIndividuals will be recruited from an existing registry (VCU IRB HMHM20000294, Keyser-Marcus, PI)'}, {'id': 'FG001', 'title': 'Individuals With Opioid Use Disorder', 'description': 'This group will consist of individuals who are determined to have DSM5 diagnosis of Opioid Use Disorder (n=200).'}, {'id': 'FG002', 'title': 'Individuals With Marijuana Use Disorder', 'description': 'This group will consist of individuals who are determined to have DSM5 diagnosis of Marijuana Use Disorder (n=50).'}, {'id': 'FG003', 'title': 'Healthy Controls', 'description': 'This group will consist of individuals who are determined to be non-drug using healthy controls (n=100).'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '54'}, {'groupId': 'FG001', 'numSubjects': '124'}, {'groupId': 'FG002', 'numSubjects': '61'}, {'groupId': 'FG003', 'numSubjects': '129'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '50'}, {'groupId': 'FG001', 'numSubjects': '97'}, {'groupId': 'FG002', 'numSubjects': '51'}, {'groupId': 'FG003', 'numSubjects': '108'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '27'}, {'groupId': 'FG002', 'numSubjects': '10'}, {'groupId': 'FG003', 'numSubjects': '21'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '17'}, {'groupId': 'FG002', 'numSubjects': '8'}, {'groupId': 'FG003', 'numSubjects': '14'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '3'}]}, {'type': 'Dropped from study', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '7'}, {'groupId': 'FG002', 'numSubjects': '2'}, {'groupId': 'FG003', 'numSubjects': '4'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'BG000'}, {'value': '97', 'groupId': 'BG001'}, {'value': '51', 'groupId': 'BG002'}, {'value': '108', 'groupId': 'BG003'}, {'value': '306', 'groupId': 'BG004'}]}], 'groups': [{'id': 'BG000', 'title': 'Individuals With Cocaine Use Disorder', 'description': 'This group will consist of individuals who are determined to have DSM5 diagnosis of Cocaine Use Disorder (n=50).\n\nIndividuals will be recruited from an existing registry (VCU IRB HMHM20000294, Keyser-Marcus, PI)'}, {'id': 'BG001', 'title': 'Individuals With Opioid Use Disorder', 'description': 'This group will consist of individuals who are determined to have DSM5 diagnosis of Opioid Use Disorder (n=200).'}, {'id': 'BG002', 'title': 'Individuals With Marijuana Use Disorder', 'description': 'This group will consist of individuals who are determined to have DSM5 diagnosis of Marijuana Use Disorder (n=50).'}, {'id': 'BG003', 'title': 'Healthy Controls', 'description': 'This group will consist of individuals who are determined to be non-drug using healthy controls (n=100).'}, {'id': 'BG004', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '51.78', 'spread': '8.76', 'groupId': 'BG000'}, {'value': '42.49', 'spread': '11.57', 'groupId': 'BG001'}, {'value': '35.24', 'spread': '13.10', 'groupId': 'BG002'}, {'value': '35.69', 'spread': '14.51', 'groupId': 'BG003'}, {'value': '40.77', 'spread': '13.82', 'groupId': 'BG004'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '13', 'groupId': 'BG000'}, {'value': '45', 'groupId': 'BG001'}, {'value': '22', 'groupId': 'BG002'}, {'value': '64', 'groupId': 'BG003'}, {'value': '144', 'groupId': 'BG004'}]}, {'title': 'Male', 'measurements': [{'value': '37', 'groupId': 'BG000'}, {'value': '52', 'groupId': 'BG001'}, {'value': '29', 'groupId': 'BG002'}, {'value': '44', 'groupId': 'BG003'}, {'value': '162', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}, {'value': '7', 'groupId': 'BG004'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '44', 'groupId': 'BG000'}, {'value': '91', 'groupId': 'BG001'}, {'value': '46', 'groupId': 'BG002'}, {'value': '99', 'groupId': 'BG003'}, {'value': '280', 'groupId': 'BG004'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}, {'value': '6', 'groupId': 'BG003'}, {'value': '19', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'Race', 'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '4', 'groupId': 'BG003'}, {'value': '5', 'groupId': 'BG004'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '8', 'groupId': 'BG003'}, {'value': '10', 'groupId': 'BG004'}]}, {'title': 'Native Hawaiian or 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': '48', 'groupId': 'BG000'}, {'value': '72', 'groupId': 'BG001'}, {'value': '31', 'groupId': 'BG002'}, {'value': '42', 'groupId': 'BG003'}, {'value': '193', 'groupId': 'BG004'}]}, {'title': 'White', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '23', 'groupId': 'BG001'}, {'value': '17', 'groupId': 'BG002'}, {'value': '47', 'groupId': 'BG003'}, {'value': '88', 'groupId': 'BG004'}]}, {'title': 'Other', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '6', 'groupId': 'BG003'}, {'value': '8', 'groupId': 'BG004'}]}, {'title': 'Unknown or not reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '2', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '50', 'groupId': 'BG000'}, {'value': '97', 'groupId': 'BG001'}, {'value': '51', 'groupId': 'BG002'}, {'value': '108', 'groupId': 'BG003'}, {'value': '306', 'groupId': 'BG004'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2019-06-12', 'size': 780960, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_001.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2021-07-13T10:57', 'hasProtocol': True}, {'date': '2019-11-22', 'size': 243126, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_000.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2021-01-22T09:33', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 368}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-06-21', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-07', 'completionDateStruct': {'date': '2020-03-16', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-07-13', 'studyFirstSubmitDate': '2018-03-29', 'resultsFirstSubmitDate': '2021-07-13', 'studyFirstSubmitQcDate': '2018-04-10', 'lastUpdatePostDateStruct': {'date': '2021-08-04', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2021-07-13', 'studyFirstPostDateStruct': {'date': '2018-04-12', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2021-08-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-03-16', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Performance on Measures of Cognition Across Conditions', 'timeFrame': '5 hours', 'description': 'Performance (time to complete)\n\n#correct) on behavioral tasks which examine cognitive functioning (e.g., Backwards digit span, and stop signal reaction task)'}, {'measure': 'Performance on Measures of Reward Processing Across Conditions', 'timeFrame': '5 hours', 'description': 'Performance (time to complete)\n\n#correct) on behavioral tasks which examine Reward processing (e.g., hypothetical purchase task) and subscale and total scale scores on self-report measures of reward processing (SUPP-S)'}, {'measure': 'Performance on Measures of Negative Emotionality Across Conditions', 'timeFrame': '5 hours', 'description': 'Performance (time to complete)\n\n#correct) on behavioral tasks which examine Negative Emotionality (Emotional go/nogo) and subscale and total scale scores on self-report measures of Negative Emotionality (Buss Perry Aggression)'}, {'measure': 'Self-report on Measure of Interoception Across Conditions', 'timeFrame': '5 hours', 'description': 'Performance (time to complete)'}, {'measure': 'Self-report on Measure of Metacognition Across Conditions', 'timeFrame': '5 hours', 'description': 'Performance (time to complete)'}, {'measure': 'Self-report on Measure of Sleep Quality Across Conditions', 'timeFrame': '5 hours', 'description': 'Performance (time to complete)'}, {'measure': 'Between-group Differences in Brain Connectivity as Measured by Spectral Dynamic Causal Modeling (DCM) and Deterministic Dynamic Causal Modeling', 'timeFrame': '1 month', 'description': 'Between-group differences in brain connectivity as measured by Spectral dynamic causal modeling (DCM) and Deterministic dynamic causal modeling'}], 'primaryOutcomes': [{'measure': 'Retention', 'timeFrame': '1 month', 'description': 'Number of dropouts'}], 'secondaryOutcomes': [{'measure': 'Time to Complete Battery', 'timeFrame': '5 hours', 'description': 'Time to complete the assessment batteries will also be recorded for each task and each participant.'}, {'measure': 'Non-completers of the Battery and Platform Instruments', 'timeFrame': '5 hours', 'description': 'Number of study completers who did not complete the full battery and platform instruments'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Opioid-use Disorder', 'Cocaine Use Disorder', 'Marijuana Use Disorder', 'Healthy Controls']}, 'descriptionModule': {'briefSummary': 'The overall goal of this project is to collect preliminary data on psychosocial measures and behavioral performance comparing individuals with Opioid Use Disorder, Cocaine Use Disorder, dual diagnosis of Opioid and Cocaine Use Disorder, and Healthy Controls in an effort to determine overall feasibility of a phenotypic "fingerprint" for cohorts of individuals with addictions for use during clinical trials.', 'detailedDescription': 'There is profound heterogeneity of subjects in clinical studies of addictions, with patients being diagnosed by the primary substance of use. As a result, utilizing current DSM addictions classification leads to problems with signal detection and hamper the progress of the development of new drugs and treatments for substance use disorders (SUDs). Getting beyond the DSM-5 based definitions is necessary to "fingerprint" addiction phenotypes and endophenotypes, using machine-learning analyses of big data. A detailed in-depth assessment of addiction phenotypes (deep phenotyping) may also include neuroimaging.\n\nIn an effort to develop a "fingerprint" for addiction phenotypes, NIDA established a Workgroup to develop a phenotyping battery of tests and self-rated psychometric scales, supplemented by resting state fMRI to be administered to participants in any extramural clinical trial where addictions are assessed. The final phenotyping battery content was determined via consensus from both the selected experts- consultants group and the NIDA workgroup, and as such, the battery requires feasibility and validation study to finalize its content. The NIDA Phenotyping Assessment Battery (PhAB) covers six neurofunctional addiction domains: Metacognition, Interoception, Cognition/Executive Function, Reward/Incentive Salience, Emotion/Negative Emotionality, and Sleep/Circadian Rhythm. The PhAB is meant to be administered during a Phenotyping visit - an extension of a screening visit in any clinical trial addictions protocol. In addition to the PhAB, the group also developed an ancillary set of measures to be administered in conjunction with the PhAB in any addictions clinical trial during the Phenotyping visit. The Platform Instruments include structured interviews, diagnostic measures (e.g., MINI), self report scales of symptom severity (e.g., ASRS-ADHD, VAS-Pain), trauma history (CTQ), computer-administered measures of intelligence (e.g., Shipley), and substance use measures (FTND, Timeline Follow-back), etc. Clinical trial investigators would administer these scales and behavioral tasks in addition to protocol nonspecific assessments (e.g., demographics) and medical evaluations (e.g, medical history and physical exams, genotyping, and labs) which could be done at Screening.\n\nThis study is a feasibility, construct and face validity study. The primary outcome measure is time taken to complete the battery, and rates of successful study completion'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'The study utilizes a four-group cross sectional cohort design. A total of 400 participants (across 4 cohorts) are targeted to complete the study) to include: Healthy Controls (n=100), individuals with CocUD (n=50), individuals with OUD (n=200), and individuals with MJUD (n=50).', 'eligibilityCriteria': 'Inclusion Criteria (Individuals with SUDs)\n\n* Males and females between 18 and 70 years-of-age.\n* Current DSM-5 primary Substance Use Disorder: Opioid, marijuana, stimulants (individuals with multiple types of substance use (e.g., opioid/marijuana will be included)\n* Have no contraindications for study participation as determined by medical history and concomitant medications.\n* Be able to demonstrate an understanding of study procedures and follow instructions including behavioral laboratory testing.\n* Be able and willing to comply with scheduled visits, and other study procedures.\n* Be able to read and complete forms and interviews in English.\n\nInclusion Criteria (Non-drug Using Healthy Controls)\n\n* Males and females between 18 and 70 years of age.\n* Have no contraindications for study participation as determined by medical history and concomitant medications.\n* Be able to demonstrate an understanding of study procedures and follow instructions including behavioral laboratory testing.\n* Be able and willing to comply with scheduled visits, and other study\n* Be able to read and complete forms and interviews in English.\n\nGeneral Exclusion Criteria\n\n* Current psychosis, mania, or suicidal/homicidal ideation\n* Meet current DSM-5 diagnosis of any psychoactive substance use disorder other than opioids,marijuana, stimulants, or nicotine. Diagnosis of mild to moderate use disorder for alcohol will not be considered exclusionary for any SUD group.\n* Have a history of seizures (excluding childhood febrile seizures), or loss of consciousness from traumatic injury for more than 30 minutes.\n* Have any other illness, or condition, which in the opinion of the PI or study physician would preclude safe and/or successful completion of the study.\n\nMRI Exclusion Criteria\n\n* Metal fragments or implants, and/or history of fear of being in closed spaces for MRI scans.\n* Currently pregnant or nursing.'}, 'identificationModule': {'nctId': 'NCT03495869', 'acronym': 'PhAB', 'briefTitle': 'Feasibility and Validation of a Standard Phenotyping Assessment Battery', 'organization': {'class': 'OTHER', 'fullName': 'Virginia Commonwealth University'}, 'officialTitle': 'NIDA Phenotyping Assessments Battery (PhAB) Feasibility and Validation Study in Non-Intoxicated Drug Users', 'orgStudyIdInfo': {'id': 'HM20012559'}, 'secondaryIdInfos': [{'id': 'U54DA038999', 'link': 'https://reporter.nih.gov/quickSearch/U54DA038999', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'Individuals with Cocaine Use Disorder', 'description': 'This group will consist of individuals who are determined to have DSM5 diagnosis of Cocaine Use Disorder (n=50).\n\nIndividuals will be recruited from an existing registry (VCU IRB HMHM20000294, Keyser-Marcus, PI)'}, {'label': 'Individuals with Opioid Use Disorder', 'description': 'This group will consist of individuals who are determined to have DSM5 diagnosis of Opioid Use Disorder (n=200).'}, {'label': 'Individuals with Marijuana Use Disorder', 'description': 'This group will consist of individuals who are determined to have DSM5 diagnosis of Marijuana Use Disorder (n=50).'}, {'label': 'Healthy Controls', 'description': 'This group will consist of individuals who are determined to be non-drug using healthy controls (n=100).'}]}, 'contactsLocationsModule': {'locations': [{'zip': '23219', 'city': 'Richmond', 'state': 'Virginia', 'country': 'United States', 'facility': 'VCU Institute for Drug and Alcohol Studies', 'geoPoint': {'lat': 37.55376, 'lon': -77.46026}}], 'overallOfficials': [{'name': 'Lori Keyser-Marcus, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Virginia Commonwealth University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Virginia Commonwealth University', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institute on Drug Abuse (NIDA)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}