Ignite Creation Date:
2025-12-25 @ 12:59 AM
Ignite Modification Date:
2025-12-25 @ 11:12 PM
Study NCT ID:
NCT02110693
Status:
COMPLETED
Last Update Posted:
2018-07-26
First Post:
2014-04-02
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
The Tobacco, Alcohol, Prescription Medication and Other Substances Tool
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D019966', 'term': 'Substance-Related Disorders'}], 'ancestors': [{'id': 'D064419', 'term': 'Chemically-Induced Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D007407', 'term': 'Interviews as Topic'}], 'ancestors': [{'id': 'D003625', 'term': 'Data Collection'}, {'id': 'D004812', 'term': 'Epidemiologic Methods'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D017531', 'term': 'Health Care Evaluation Mechanisms'}, {'id': 'D011787', 'term': 'Quality of Health Care'}, {'id': 'D017530', 'term': 'Health Care Quality, Access, and Evaluation'}, {'id': 'D011634', 'term': 'Public Health'}, {'id': 'D004778', 'term': 'Environment and Public Health'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'rschwartz@friendsresearch.org', 'phone': '410-837-3977', 'title': 'Robert Schwartz', 'phoneExt': '276', 'organization': 'Friends Research Institute'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'Baseline data only gathered in this study.', 'description': 'The all cause mortality and serious adverse event data refer to the total combined sample (n = 2,000). We report the total sample here because all participants received both the interviewer and self-administered versions one immediately after the other in one single session.', 'eventGroups': [{'id': 'EG000', 'title': 'All Participants', 'description': 'All participants enrolled in the study (because all participants were administered both the self-administered and the interviewer administered versions of the instrument, we are reporting adverse events for the total sample)', 'otherNumAtRisk': 2000, 'deathsNumAtRisk': 2000, 'otherNumAffected': 16, 'seriousNumAtRisk': 2000, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Blood on oral swab', 'notes': 'Traces of blood were seen on oral swab', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2000, 'numEvents': 16, 'numAffected': 16}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Diagnostic and Statistical Manual-5 (DSM-5) Alcohol Use Disorder Diagnosis Measured by the Modified World Mental Health Composite International Diagnostic Interview', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2000', 'groupId': 'OG000'}, {'value': '2000', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Interviewer Administration', 'description': 'Interviewer administration of a substance misuse screening instrument (TAPS Tool).'}, {'id': 'OG001', 'title': 'Tablet Administration', 'description': 'Self-administration on tablet computer of screening instrument for substance misuse (TAPS Tool).'}], 'classes': [{'categories': [{'measurements': [{'value': '.70', 'groupId': 'OG000', 'lowerLimit': '.64', 'upperLimit': '.75'}, {'value': '.74', 'groupId': 'OG001', 'lowerLimit': '.68', 'upperLimit': '.79'}]}]}], 'analyses': [{'groupIds': ['OG000'], 'paramType': 'Sensitivity', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '.70', 'ciLowerLimit': '.64', 'ciUpperLimit': '.75', 'groupDescription': 'Each administration approach (interviewer and tablet) was tested separately against the reference measure.', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'Concurrent validity of the interviewer and self-administered versions of the TAPS Tool compared to the reference standard was assessed for Alcohol Use Disorder using receiver operator characteristic (ROC) curves.'}, {'groupIds': ['OG001'], 'paramType': 'Sensitivity', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '.74', 'ciLowerLimit': '.68', 'ciUpperLimit': '.79', 'groupDescription': 'Each administration approach (interviewer and tablet) was tested separately against the reference measure.', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'Concurrent validity of the interviewer and self-administered versions of the TAPS Tool compared to the reference standard was assessed for Alcohol Use Disorder using receiver operator characteristic (ROC) curves.'}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline', 'description': 'The Modified World Mental Health Composite International Diagnostic Interview is a structured interview that assesses whether or not the participant meets DSM-5 Diagnostic Criteria', 'unitOfMeasure': 'Sensitivity', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Adult primary care patients'}, {'type': 'PRIMARY', 'title': 'Diagnostic and Statistical Manual-5 (DSM-5) Cannabis Use Disorder Diagnosis Measured With Modified World Mental Health Composite International Diagnostic Interview', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2000', 'groupId': 'OG000'}, {'value': '2000', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Interviewer Administration', 'description': 'Interviewer administration of a substance misuse screening instrument (TAPS Tool)'}, {'id': 'OG001', 'title': 'Tablet Administration', 'description': 'Tablet computer administration of a substance misuse screening instrument (TAPS Tool).'}], 'classes': [{'categories': [{'measurements': [{'value': '0.71', 'groupId': 'OG000', 'lowerLimit': '.63', 'upperLimit': '.79'}, {'value': '.70', 'groupId': 'OG001', 'lowerLimit': '.62', 'upperLimit': '.77'}]}]}], 'analyses': [{'groupIds': ['OG000'], 'paramType': 'Sensitivity', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '.71', 'ciLowerLimit': '.63', 'ciUpperLimit': '.79', 'groupDescription': 'Each administration approach (interviewer and tablet) were separately tested against the reference measure.', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'Concurrent validity of the interviewer and self-administered versions of the TAPS Tool compared to the reference standard was assessed for Cannabis Use Disorder using receiver operator characteristic (ROC) curves.'}, {'groupIds': ['OG001'], 'paramType': 'Sensitivity', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '.70', 'ciLowerLimit': '.62', 'ciUpperLimit': '.77', 'groupDescription': 'Each administration approach (interviewer and tablet) were separately tested against the reference measure.', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'Concurrent validity of the interviewer and self-administered versions of the TAPS Tool compared to the reference standard was assessed for Cannabis Use Disorder using receiver operator characteristic (ROC) curves.'}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline', 'description': 'The Modified World Mental Health Composite International Diagnostic Interview is a structured interview that assesses whether or not the participant meets DSM-5 Diagnostic Criteria', 'unitOfMeasure': 'Sensitivity', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Adult primary care population'}, {'type': 'PRIMARY', 'title': 'Diagnostic and Statistical Manual-5 (DSM-5) Cocaine and Amphetamine (Stimulant) Use Disorder Diagnosis Measured by the Modified World Mental Health Composite International Diagnostic Interview', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2000', 'groupId': 'OG000'}, {'value': '2000', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Interviewer Administration', 'description': 'Interviewer administration of a substance misuse screening instrument (TAPS Tool).'}, {'id': 'OG001', 'title': 'Tablet Administration', 'description': 'Tablet computer administration of a substance misuse screening instrument (TAPS Tool).'}], 'classes': [{'categories': [{'measurements': [{'value': '.57', 'groupId': 'OG000', 'lowerLimit': '.47', 'upperLimit': '.67'}, {'value': '.60', 'groupId': 'OG001', 'lowerLimit': '.50', 'upperLimit': '.69'}]}]}], 'analyses': [{'groupIds': ['OG000'], 'paramType': 'Sensitivity', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '.57', 'ciLowerLimit': '.47', 'ciUpperLimit': '.67', 'groupDescription': 'Each administration approach (interviewer and tablet) were tested separately against the reference measure.', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'Concurrent validity of the interviewer and self-administered versions of the TAPS Tool compared to the reference standard was assessed for Cocaine and Amphetamine (Stimulant) Disorder using receiver operator characteristic (ROC) curves.'}, {'groupIds': ['OG001'], 'paramType': 'Sensitivity', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '.60', 'ciLowerLimit': '.50', 'ciUpperLimit': '.69', 'groupDescription': 'Each administration approach (interviewer and tablet) were separately tested against the reference measure.', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'Concurrent validity of the interviewer and self-administered versions of the TAPS Tool compared to the reference standard was assessed for Cocaine and Amphetamine (Stimulant) Use Disorder using receiver operator characteristic (ROC) curves.'}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline', 'description': 'The Modified World Mental Health Composite International Diagnostic Interview is a structured interview that assesses whether or not the participant meets DSM-5 Diagnostic Criteria', 'unitOfMeasure': 'Sensitivity', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Adult primary care patients'}, {'type': 'PRIMARY', 'title': 'Diagnostic and Statistical Manual DSM-5 Diagnosis of Heroin Use Disorder Measured by the The Modified World Mental Health Composite International Diagnostic Interview', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2000', 'groupId': 'OG000'}, {'value': '2000', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Interviewer Administration', 'description': 'Interviewer administration of a substance misuse screening instrument (TAPS Tool).'}, {'id': 'OG001', 'title': 'Tablet Administration', 'description': 'Tablet computer of a substance misuse screening instrument (TAPS Tool).'}], 'classes': [{'categories': [{'measurements': [{'value': '.66', 'groupId': 'OG000', 'lowerLimit': '.53', 'upperLimit': '.77'}, {'value': '.66', 'groupId': 'OG001', 'lowerLimit': '.53', 'upperLimit': '.77'}]}]}], 'analyses': [{'groupIds': ['OG000'], 'paramType': 'sensivity', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '.66', 'ciLowerLimit': '.53', 'ciUpperLimit': '.77', 'groupDescription': 'Each administration approach (interviewer and tablet) were tested separately against the reference measure.', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'Concurrent validity of the interviewer and self-administered versions of the TAPS Tool compared to the reference standard was assessed for Heroin Use Disorder using receiver operator characteristic (ROC) curves.'}, {'groupIds': ['OG001'], 'paramType': 'Sensivity', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '.66', 'ciLowerLimit': '.53', 'ciUpperLimit': '.77', 'groupDescription': 'Each administration approach (interviewer and tablet) were tested separately against the reference measure.', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'Concurrent validity of the interviewer and self-administered versions of the TAPS Tool compared to the reference standard was assessed for Heroin Use Disorder using receiver operator characteristic (ROC) curves.'}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline', 'description': 'The Modified World Mental Health Composite International Diagnostic Interview is a structured interview that assesses whether or not the participant meets DSM-5 Diagnostic Criteria', 'unitOfMeasure': 'Sensitivity', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Adult primary care patients'}, {'type': 'PRIMARY', 'title': 'Diagnostic and Statistical Manual DSM-5 Diagnosis of Tobacco Use Disorder Measured by the Modified World Mental Health Composite International Diagnostic Interview', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2000', 'groupId': 'OG000'}, {'value': '2000', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Interviewer Administration', 'description': 'Interviewer administration of a substance misuse screening instrument (TAPS Tool).'}, {'id': 'OG001', 'title': 'Tablet Administration', 'description': 'Tablet computer administration of a substance misuse screening instrument (TAPS Tool).'}], 'classes': [{'categories': [{'measurements': [{'value': '.74', 'groupId': 'OG000', 'lowerLimit': '.69', 'upperLimit': '.77'}, {'value': '.73', 'groupId': 'OG001', 'lowerLimit': '.69', 'upperLimit': '.77'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline', 'description': 'The Modified World Mental Health Composite International Diagnostic Interview is a structured interview that assesses whether or not the participant meets DSM-5 Diagnostic Criteria', 'unitOfMeasure': 'Sensivity', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'adult primary care patients'}, {'type': 'SECONDARY', 'title': 'High Risk Tobacco Use Measured by the Alcohol, Smoking, and Substance Involvement Screening Test (ASSIST)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2000', 'groupId': 'OG000'}, {'value': '2000', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Interviewer Administered', 'description': 'Interviewer administration of TAPS Tool. The ASSIST was interviewer administered as well.'}, {'id': 'OG001', 'title': 'Tablet Administration', 'description': 'Tablet computer administration of TAPS Tool. The ASSIST was administered in by an interview.'}], 'classes': [{'categories': [{'measurements': [{'value': '.90', 'groupId': 'OG000', 'lowerLimit': '.83', 'upperLimit': '.94'}, {'value': '.90', 'groupId': 'OG001', 'lowerLimit': '.83', 'upperLimit': '.94'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline', 'description': 'The ASSIST assess lifetime and past 3 month substance use. A score on the Tobacco Scale from 0-3 is low risk, 4-26 is medium risk, and 27 or greater is high risk.The scales range is from 0 (no problem) to 31 (most severe problem).', 'unitOfMeasure': 'Sensitivity', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Adult primary care patients'}, {'type': 'SECONDARY', 'title': 'Unhealthy Cannabis Use', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2000', 'groupId': 'OG000'}, {'value': '2000', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Interviewer Administered', 'description': 'Interviewer administered TAPS. The Time Line Follow Back was interviewer administered.'}, {'id': 'OG001', 'title': 'Tablet Administration', 'description': 'Tablet computer administration of TAPS Tool. The TLFB was interviewer administered.'}], 'classes': [{'categories': [{'measurements': [{'value': '.85', 'groupId': 'OG000', 'lowerLimit': '.82', 'upperLimit': '.88'}, {'value': '.84', 'groupId': 'OG001', 'lowerLimit': '.81', 'upperLimit': '.88'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline', 'description': "The Time Line Follow Back Interview measures participant's self-reported number of days of cannabis use in the 30 days prior to the interview. Unhealthy cannabis use is considered 1 or more days of cannabis use in the past 30 days.The reported data represent the correlation between the TAPS Tool Cannabis Score and the Number of Days of cannabis use", 'unitOfMeasure': 'Spearman Correlation', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Risky Alcohol Use', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2000', 'groupId': 'OG000'}, {'value': '2000', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Self-administered', 'description': 'Self-administered TAPS Tool. The AUDIT-C was interviewer administered.'}, {'id': 'OG001', 'title': 'Interviewer Administered', 'description': 'Interviewer administered TAPS Tool. The AUDIT-C was interviewer administered for both group'}], 'classes': [{'categories': [{'measurements': [{'value': '.63', 'groupId': 'OG000', 'lowerLimit': '.59', 'upperLimit': '.66'}, {'value': '.64', 'groupId': 'OG001', 'lowerLimit': '.61', 'upperLimit': '.68'}]}]}], 'analyses': [{'groupIds': ['OG000'], 'paramType': 'Spearman Correlation', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '.63', 'ciLowerLimit': '.59', 'ciUpperLimit': '.66', 'estimateComment': 'The estimated value is a Spearman Correlation point estimate between TAPS Tool Alcohol Score and the AUDIT-C score. A Confidence Interval rather than a dispersion value is therefore reported.', 'groupDescription': 'Each administration approach (interviewer and tablet) were tested separately against the reference measure.', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'The association on the interviewer and tablet computer administered versions of the TAPS Tool compared to the reference standard AUDIT-C score was assessed using Spearman Correlation.'}, {'groupIds': ['OG001'], 'paramType': 'Spearman Correlation', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '.64', 'ciLowerLimit': '.61', 'ciUpperLimit': '.68', 'estimateComment': 'The estimated value is a Spearman Correlation point estimate between TAPS Tool Alcohol Score and the AUDIT-C Score. A Confidence Interval rather than a dispersion value is therefore reported.', 'groupDescription': 'Each administration approach (interviewer and tablet) was tested separately against the reference measure.', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'The association on the interviewer and tablet administered versions of the TAPS Tool compared to the reference standard of the AUDIT C score was assessed using Spearman Correlation.'}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline', 'description': 'Measured by the Alcohol Use Disorders Identification Test - Consumption Items. High risk on the AUDIT-C is 10 or higher. The higher the score on the AUDIT-C the greater the alcohol problem.The range of scores on the AUDIT-C is from 0 (no problem) to 12 (maximum problem).', 'unitOfMeasure': 'Spearman Correlation', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Adult Primary Care Patients'}, {'type': 'SECONDARY', 'title': 'Cigarette Smoking Risk', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2000', 'groupId': 'OG000'}, {'value': '2000', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Self-administered TAPS Tool', 'description': 'Self-administered TAPS Tool. The Fagerstrom Test for Nicotine Dependence was administered by interviewer.'}, {'id': 'OG001', 'title': 'Interviewer Administered', 'description': 'Interviewer administered TAPS Tool. The Fagerstrom Test was interviewer administered.'}], 'classes': [{'categories': [{'measurements': [{'value': '.73', 'groupId': 'OG000', 'lowerLimit': '.70', 'upperLimit': '.76'}, {'value': '.75', 'groupId': 'OG001', 'lowerLimit': '.73', 'upperLimit': '.77'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'baseline', 'description': 'Measured by the Fagerstrom Test for Nicotine Dependence. The range of scores on the Fagerstrom Test if from 0 (no risk) to 10 (highest risk). High risk is considered a score of 6 or greater.', 'unitOfMeasure': 'Spearman Correlation', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Adult Primary Care patients'}, {'type': 'SECONDARY', 'title': 'Smokeless Tobacco Questionnaire', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2000', 'groupId': 'OG000'}, {'value': '2000', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Interviewer Administered', 'description': 'Interviewer administered TAPS Tool. The Smokeless Tobacco Questionnaire was interviewer administered.'}, {'id': 'OG001', 'title': 'Self Administered', 'description': 'Self-administered TAPS Tool. The Smokeless Tobacco Questionnaire was interviewer administered.'}], 'classes': [{'categories': [{'measurements': [{'value': '.29', 'groupId': 'OG000', 'lowerLimit': '.25', 'upperLimit': '.33'}, {'value': '.28', 'groupId': 'OG001', 'lowerLimit': '.24', 'upperLimit': '.32'}]}]}], 'analyses': [{'groupIds': ['OG000'], 'paramType': 'Spearman Correlation', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '.29', 'ciLowerLimit': '.25', 'ciUpperLimit': '.33', 'estimateComment': 'The estimated value is a Spearman Correlation point estimate between the TAPS Tool Tobacco Score and the Smokeless Tobacco Questionnare. Confidence Interval rather than a dispersion value is therefore reported.', 'groupDescription': 'Each administration approach (interviewer and tablet computer) was tested separately against the reference measure.', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'The association on the interviewer and tablet computer administered versions of the TAPS Tool compared to the reference standard Smokeless Tobacco Questionnaire was assessed using Spearman Correlation.'}, {'groupIds': ['OG001'], 'paramType': 'Spearman Correlation', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '.28', 'ciLowerLimit': '.24', 'ciUpperLimit': '.32', 'estimateComment': 'The estimated value is a Spearman Correlation point estimate between TAPS Tool Tobacco Score and the score on the Smokeless Tobacco Questionnaire. A Confidence Interval rather than a dispersion value is therefore reported.', 'groupDescription': 'Each administration approach (interviewer and tablet) were tested separately against the reference measure.', 'nonInferiorityType': 'OTHER'}], 'paramType': 'NUMBER', 'timeFrame': 'baseline', 'description': 'Any yes response to smokeless tobacco use reported on the smokeless tobacco questionnaire is considered high risk.', 'unitOfMeasure': 'Spearman Correlation', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Adult Primary Care patients'}, {'type': 'SECONDARY', 'title': 'Cannabis Positive Oral Fluid Test', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1802', 'groupId': 'OG000'}, {'value': '1802', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Interviewer Administered', 'description': 'Interviewer administered TAPS Tool. Oral Fluid Cannabis Test administered to the subset of participants that consented to provide an oral fluid sample. Oral fluid specimen was collected the same way in both arms.'}, {'id': 'OG001', 'title': 'Self-administered TAPS Tool', 'description': 'Self administered TAPS Tool. Oral Fluid Cannabis Test administered to the subset of participants that consented to provide an oral fluid sample. Oral fluid specimen was collected the same way in both arms.'}], 'classes': [{'categories': [{'measurements': [{'value': '.42', 'groupId': 'OG000'}, {'value': '.40', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000'], 'paramType': 'Spearman Correlation', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '.42', 'ciLowerLimit': '.35', 'ciUpperLimit': '.48', 'estimateComment': 'The estimated value is a Spearman Correlation point estimate between TAPS Tool Cannabis Score and the results of the Oral Fluid Test. Confidence Interval rather than a dispersion value is therefore reported.', 'groupDescription': 'Each administration approach (interviewer and tablet) were tested separately against the reference measure.', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'The association on the interviewer and tablet computer administered versions of the TAPS Tool compared to the reference standard of the results of the oral fluid test was assessed using Spearman Correlation.'}, {'groupIds': ['OG001'], 'paramType': 'Spearman Correlation', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '.40', 'ciLowerLimit': '.33', 'ciUpperLimit': '.46', 'estimateComment': 'The estimated value is a point estimate of the Spearman Correlation between the TAPS Tool Cannabis Score and the Oral Fluid Cannabis Screen. A Confidence Interval rather than a dispersion value is therefore reported.', 'nonInferiorityType': 'OTHER'}], 'paramType': 'NUMBER', 'timeFrame': 'baseline', 'description': 'Positive Oral Fluid Cannabis testing.', 'unitOfMeasure': 'Spearman Correlation', 'reportingStatus': 'POSTED', 'populationDescription': 'Adult Primary Care Patients with oral fluid test results'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Interviewer Then Tablet Administration', 'description': 'Interviewer will administer the substance use screening instrument first then self-administration of the same instrument on a tablet computer'}, {'id': 'FG001', 'title': 'Tablet First Then Interviewer Administration', 'description': 'Self-administration on tablet computer of screening instrument first, then interviewer administration of the same instrument.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1026'}, {'groupId': 'FG001', 'numSubjects': '1031'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '998'}, {'groupId': 'FG001', 'numSubjects': '1002'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '28'}, {'groupId': 'FG001', 'numSubjects': '29'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '7'}]}, {'type': 'skipped assessment', 'reasons': [{'groupId': 'FG000', 'numSubjects': '15'}, {'groupId': 'FG001', 'numSubjects': '18'}]}, {'type': 'technical difficulties', 'reasons': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '4'}]}, {'type': 'Other', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '2,000', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Interviewer and Tablet Administration of TAPS Tool', 'description': 'All participants self-administered TAPS Tool on a computer tablet and were administered the TAPS Tool by an interviewer'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '2,000', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '46.0', 'spread': '14.7', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '1,998', 'groupId': 'BG000'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '1124', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '874', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Missing data (n=1) and refused to answer (n=1)'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '2,000', 'groupId': 'BG000'}]}], 'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '233', 'groupId': 'BG000'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '1761', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '6', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '2,000', 'groupId': 'BG000'}]}], 'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '12', 'groupId': 'BG000'}]}, {'title': 'Asian', 'measurements': [{'value': '35', 'groupId': 'BG000'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Black or African American', 'measurements': [{'value': '1112', 'groupId': 'BG000'}]}, {'title': 'White', 'measurements': [{'value': '667', 'groupId': 'BG000'}]}, {'title': 'More than one race', 'measurements': [{'value': '66', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '108', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Participant chose not to answer (n=7)'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2,000', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '2000', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SCREENING', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'This study examined the accuracy of a substance abuse screening test compared to gold standard measures Participants all received the experimental screening instrument (via self- and tablet computer administration. The order of administration was randomly selected in order to control for an order effect.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 2057}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-06', 'completionDateStruct': {'date': '2015-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-06-29', 'studyFirstSubmitDate': '2014-04-02', 'resultsFirstSubmitDate': '2016-10-25', 'studyFirstSubmitQcDate': '2014-04-08', 'lastUpdatePostDateStruct': {'date': '2018-07-26', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2018-03-15', 'studyFirstPostDateStruct': {'date': '2014-04-10', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2018-04-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2015-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Diagnostic and Statistical Manual-5 (DSM-5) Alcohol Use Disorder Diagnosis Measured by the Modified World Mental Health Composite International Diagnostic Interview', 'timeFrame': 'Baseline', 'description': 'The Modified World Mental Health Composite International Diagnostic Interview is a structured interview that assesses whether or not the participant meets DSM-5 Diagnostic Criteria'}, {'measure': 'Diagnostic and Statistical Manual-5 (DSM-5) Cannabis Use Disorder Diagnosis Measured With Modified World Mental Health Composite International Diagnostic Interview', 'timeFrame': 'Baseline', 'description': 'The Modified World Mental Health Composite International Diagnostic Interview is a structured interview that assesses whether or not the participant meets DSM-5 Diagnostic Criteria'}, {'measure': 'Diagnostic and Statistical Manual-5 (DSM-5) Cocaine and Amphetamine (Stimulant) Use Disorder Diagnosis Measured by the Modified World Mental Health Composite International Diagnostic Interview', 'timeFrame': 'Baseline', 'description': 'The Modified World Mental Health Composite International Diagnostic Interview is a structured interview that assesses whether or not the participant meets DSM-5 Diagnostic Criteria'}, {'measure': 'Diagnostic and Statistical Manual DSM-5 Diagnosis of Heroin Use Disorder Measured by the The Modified World Mental Health Composite International Diagnostic Interview', 'timeFrame': 'Baseline', 'description': 'The Modified World Mental Health Composite International Diagnostic Interview is a structured interview that assesses whether or not the participant meets DSM-5 Diagnostic Criteria'}, {'measure': 'Diagnostic and Statistical Manual DSM-5 Diagnosis of Tobacco Use Disorder Measured by the Modified World Mental Health Composite International Diagnostic Interview', 'timeFrame': 'Baseline', 'description': 'The Modified World Mental Health Composite International Diagnostic Interview is a structured interview that assesses whether or not the participant meets DSM-5 Diagnostic Criteria'}], 'secondaryOutcomes': [{'measure': 'High Risk Tobacco Use Measured by the Alcohol, Smoking, and Substance Involvement Screening Test (ASSIST)', 'timeFrame': 'Baseline', 'description': 'The ASSIST assess lifetime and past 3 month substance use. A score on the Tobacco Scale from 0-3 is low risk, 4-26 is medium risk, and 27 or greater is high risk.The scales range is from 0 (no problem) to 31 (most severe problem).'}, {'measure': 'Unhealthy Cannabis Use', 'timeFrame': 'Baseline', 'description': "The Time Line Follow Back Interview measures participant's self-reported number of days of cannabis use in the 30 days prior to the interview. Unhealthy cannabis use is considered 1 or more days of cannabis use in the past 30 days.The reported data represent the correlation between the TAPS Tool Cannabis Score and the Number of Days of cannabis use"}, {'measure': 'Risky Alcohol Use', 'timeFrame': 'Baseline', 'description': 'Measured by the Alcohol Use Disorders Identification Test - Consumption Items. High risk on the AUDIT-C is 10 or higher. The higher the score on the AUDIT-C the greater the alcohol problem.The range of scores on the AUDIT-C is from 0 (no problem) to 12 (maximum problem).'}, {'measure': 'Cigarette Smoking Risk', 'timeFrame': 'baseline', 'description': 'Measured by the Fagerstrom Test for Nicotine Dependence. The range of scores on the Fagerstrom Test if from 0 (no risk) to 10 (highest risk). High risk is considered a score of 6 or greater.'}, {'measure': 'Smokeless Tobacco Questionnaire', 'timeFrame': 'baseline', 'description': 'Any yes response to smokeless tobacco use reported on the smokeless tobacco questionnaire is considered high risk.'}, {'measure': 'Cannabis Positive Oral Fluid Test', 'timeFrame': 'baseline', 'description': 'Positive Oral Fluid Cannabis testing.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Substance Use', 'Substance Use Disorder', 'Screening', 'Brief Assessment'], 'conditions': ['Substance Use Disorder']}, 'referencesModule': {'references': [{'pmid': '27595276', 'type': 'DERIVED', 'citation': "McNeely J, Wu LT, Subramaniam G, Sharma G, Cathers LA, Svikis D, Sleiter L, Russell L, Nordeck C, Sharma A, O'Grady KE, Bouk LB, Cushing C, King J, Wahle A, Schwartz RP. Performance of the Tobacco, Alcohol, Prescription Medication, and Other Substance Use (TAPS) Tool for Substance Use Screening in Primary Care Patients. Ann Intern Med. 2016 Nov 15;165(10):690-699. doi: 10.7326/M16-0317. Epub 2016 Sep 6."}, {'pmid': '27444426', 'type': 'DERIVED', 'citation': 'Wu LT, McNeely J, Subramaniam GA, Sharma G, VanVeldhuisen P, Schwartz RP. Design of the NIDA clinical trials network validation study of tobacco, alcohol, prescription medications, and substance use/misuse (TAPS) tool. Contemp Clin Trials. 2016 Sep;50:90-7. doi: 10.1016/j.cct.2016.07.013. Epub 2016 Jul 19.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of the study is to develop and validate a questionnaire to screen and assess adult primary care patients for tobacco, alcohol, prescription drug, and drug use and problems related to their use.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Primary care patients\n* Able to provide informed consent\n\nExclusion Criteria:\n\n* inability to comprehend spoken English\n* inability to self-administer the instrument on the tablet computer due to physical limitations\n* previously enrolled in the study'}, 'identificationModule': {'nctId': 'NCT02110693', 'acronym': 'CTN0059', 'briefTitle': 'The Tobacco, Alcohol, Prescription Medication and Other Substances Tool', 'organization': {'class': 'OTHER', 'fullName': 'Friends Research Institute, Inc.'}, 'officialTitle': 'The TAPS Tool: Screen and Brief Assessment Tool Validation Study', 'orgStudyIdInfo': {'id': 'CTN 0059'}, 'secondaryIdInfos': [{'id': '2U10DA013034', 'link': 'https://reporter.nih.gov/quickSearch/2U10DA013034', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Interviewer and tablet administration', 'description': 'All participants were administered the TAPS Tool via interviewer and tablet computer self-administration in the same session.', 'interventionNames': ['Other: Interviewer and tablet administration of the TAPS Tool']}], 'interventions': [{'name': 'Interviewer and tablet administration of the TAPS Tool', 'type': 'OTHER', 'description': 'All participant will self-administer substance use screening instrument (TAPS Tool) on a tablet computer and will be administered the TAPS Tool by an interviewer.', 'armGroupLabels': ['Interviewer and tablet administration']}]}, 'contactsLocationsModule': {'locations': [{'zip': '21201', 'city': 'Baltimore', 'state': 'Maryland', 'country': 'United States', 'facility': 'Chase Brexton Health Services', 'geoPoint': {'lat': 39.29038, 'lon': -76.61219}}, {'zip': '10016', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Bellevue Hospital', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '28081', 'city': 'Kannapolis', 'state': 'North Carolina', 'country': 'United States', 'facility': 'MURDOCK Study', 'geoPoint': {'lat': 35.48736, 'lon': -80.62173}}, {'zip': '23284', 'city': 'Richmond', 'state': 'Virginia', 'country': 'United States', 'facility': 'Virginia Commonwealth University Health System Ambulatory Care Center', 'geoPoint': {'lat': 37.55376, 'lon': -77.46026}}], 'overallOfficials': [{'name': 'Robert P Schwartz, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Friends Research Institute, Inc.'}, {'name': 'Li-Tzy Wu, Psy.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Duke University'}, {'name': 'Jennifer McNeely, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'New York University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Friends Research Institute, Inc.', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institute on Drug Abuse (NIDA)', 'class': 'NIH'}, {'name': 'Johns Hopkins University', 'class': 'OTHER'}, {'name': 'Virginia Commonwealth University', 'class': 'OTHER'}, {'name': 'NYU Langone Health', 'class': 'OTHER'}, {'name': 'Duke University', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}