Ignite Creation Date:
2025-12-26 @ 10:56 AM
Ignite Modification Date:
2026-02-25 @ 10:05 PM
Study NCT ID:
NCT03620708
Status:
COMPLETED
Last Update Posted:
2019-11-15
First Post:
2018-06-29
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Tobacco and Socioeconomic Disadvantage
Sponsor:
Organization:
Raw JSON
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recommendation to try them and are also given a written referral sheet for a local smoking cessation clinic and the New Jersey State Quit Line.\n\nNicotine Replacement Therapy Sampling: Participants are provided with a two-week sample of over-the-counter nicotine replacement therapy (i.e., nicotine lozenge and nicotine patch) and then provided with a written referral for tobacco dependence treatment.', 'otherNumAtRisk': 19, 'deathsNumAtRisk': 19, 'otherNumAffected': 0, 'seriousNumAtRisk': 19, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Referral Only', 'description': 'Participants are provided with a written referral sheet for a local smoking cessation clinic and the New Jersey State Quit Line.\n\nReferral Only: Participants are provided with a written referral for tobacco dependence treatment.', 'otherNumAtRisk': 20, 'deathsNumAtRisk': 20, 'otherNumAffected': 0, 'seriousNumAtRisk': 20, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': "Self-reported Serious Quit Attempt Measured Via the 'Quitting Preparation and Actions Questionnaire'", 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}, {'value': '17', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Motivational Interviewing', 'description': '35 minute individual motivational interviewing intervention concluding with a written referral sheet for a local smoking cessation clinic and the New Jersey State Quit Line\n\nMotivational Interviewing: Participants are provided with a 35 minute counseling session designed to increase motivation to quit smoking and then provided with a written referral for tobacco dependence treatment.'}, {'id': 'OG001', 'title': 'Nicotine Replacement Therapy Sampling', 'description': 'Participants are provided with a 2-week supply of nicotine patches and a 2 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'ciNumSides': 'TWO_SIDED', 'paramValue': '3.492', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '30 days', 'description': 'A self-described "serious" attempt to quit smoking cigarettes since the initial study appointment, measured by the "Quitting Preparation and Actions Questionnaire."', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': "Self-reported Treatment Seeking Measured Via the 'Quitting Preparation and Actions Questionnaire'", 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}, {'value': '17', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Motivational Interviewing', 'description': '35 minute individual motivational interviewing intervention concluding with a written referral sheet for a local smoking cessation clinic and the New Jersey State Quit Line\n\nMotivational 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'groups': [{'id': 'OG000', 'title': 'Motivational Interviewing', 'description': '35 minute individual motivational interviewing intervention concluding with a written referral sheet for a local smoking cessation clinic and the New Jersey State Quit Line\n\nMotivational Interviewing: Participants are provided with a 35 minute counseling session designed to increase motivation to quit smoking and then provided with a written referral for tobacco dependence treatment.'}, {'id': 'OG001', 'title': 'Nicotine Replacement Therapy Sampling', 'description': 'Participants are provided with a 2-week supply of nicotine patches and a 2 week supply of nicotine lozenges with a recommendation to try them and are also given a written referral sheet for a local smoking cessation clinic and the New Jersey State Quit Line.\n\nNicotine Replacement Therapy Sampling: Participants are provided with a two-week sample of over-the-counter nicotine replacement therapy (i.e., nicotine lozenge and nicotine patch) and then provided with a written referral for tobacco dependence treatment.'}, {'id': 'OG002', 'title': 'Referral Only', 'description': 'Participants are provided with a written referral sheet for a local smoking cessation clinic and the New Jersey State Quit Line.\n\nReferral Only: Participants are provided with a written referral for tobacco dependence treatment.'}], 'classes': [{'categories': [{'measurements': [{'value': '13.0', 'spread': '7.1', 'groupId': 'OG000'}, {'value': '7.6', 'spread': '6.3', 'groupId': 'OG001'}, {'value': '10.3', 'spread': '6.9', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '.032', 'groupIds': ['OG000', 'OG001', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'paramValue': '3.661', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': '30 days', 'description': 'Self-reported cigarettes smoked per day; abstinence to be biochemically verified with carbon monoxide \\< 5ppm', 'unitOfMeasure': 'cigarettes/day', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Importance, Confidence, & Readiness Questionnaire', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}, {'value': '17', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Motivational Interviewing', 'description': '35 minute individual motivational interviewing intervention concluding with a written referral sheet for a local smoking cessation clinic and the New Jersey State Quit Line\n\nMotivational Interviewing: Participants are provided with a 35 minute counseling session designed to increase motivation to quit smoking and then provided with a written referral for tobacco dependence treatment.'}, {'id': 'OG001', 'title': 'Nicotine Replacement Therapy Sampling', 'description': 'Participants are provided with a 2-week supply of nicotine patches and a 2 week supply of nicotine lozenges with a recommendation to try them and are also given a written referral sheet for a local smoking cessation clinic and the New Jersey State Quit Line.\n\nNicotine Replacement Therapy Sampling: Participants are provided with a two-week sample of over-the-counter nicotine replacement therapy (i.e., nicotine lozenge and nicotine patch) and then provided with a written referral for tobacco dependence treatment.'}, {'id': 'OG002', 'title': 'Referral Only', 'description': 'Participants are provided with a written referral sheet for a local smoking cessation clinic and the New Jersey State Quit Line.\n\nReferral Only: Participants are provided with a written referral for tobacco dependence treatment.'}], 'classes': [{'title': 'Confidence in ability to quit (0-10)', 'categories': [{'measurements': [{'value': '4.8', 'spread': '2.8', 'groupId': 'OG000'}, {'value': '5.5', 'spread': '3.2', 'groupId': 'OG001'}, {'value': '6.5', 'spread': '2.8', 'groupId': 'OG002'}]}]}, {'title': 'Importance of Quitting (0-10)', 'categories': [{'measurements': [{'value': '7.6', 'spread': '2.9', 'groupId': 'OG000'}, {'value': '7.3', 'spread': '3.4', 'groupId': 'OG001'}, {'value': '8.1', 'spread': '3.0', 'groupId': 'OG002'}]}]}, {'title': 'Readiness to Quit (0-10)', 'categories': [{'measurements': [{'value': '3.8', 'spread': '3.1', 'groupId': 'OG000'}, {'value': '5.1', 'spread': '3.2', 'groupId': 'OG001'}, {'value': '5.6', 'spread': '3.0', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '.227', 'groupIds': ['OG000', 'OG001', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'paramValue': '1.543', 'groupDescription': 'Examination of differences between groups at follow-up on a measure of confidence in ability to quit.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '.715', 'groupIds': ['OG000', 'OG001', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'paramValue': '0.338', 'groupDescription': 'Examination of differences between groups at follow-up on a measure of self-reported importance of quitting smoking.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '.190', 'groupIds': ['OG000', 'OG001', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'paramValue': '1.712', 'groupDescription': 'Examination of differences between groups at follow-up on a measure of self-reported readiness to quit smoking.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': '30 days', 'description': 'Motivation and Self-efficacy for quitting smoking measured via Importance, Confidence, \\& Readiness Questionnaire" (rated on a 0 to 10 scale with higher numbers indicating greater importance, confidence, or readiness to quit)', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Readiness to Quit Ladder', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}, {'value': '17', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Motivational Interviewing', 'description': '35 minute individual motivational interviewing intervention concluding with a written referral sheet for a local smoking cessation clinic and the New Jersey State Quit Line\n\nMotivational Interviewing: Participants are provided with a 35 minute counseling session designed to increase motivation to quit smoking and then provided with a written referral for tobacco dependence treatment.'}, {'id': 'OG001', 'title': 'Nicotine Replacement Therapy Sampling', 'description': 'Participants are provided with a 2-week supply of nicotine patches and a 2 week supply of nicotine lozenges with a recommendation to try them and are also given a written referral sheet for a local smoking cessation clinic and the New Jersey State Quit Line.\n\nNicotine Replacement Therapy Sampling: Participants are provided with a two-week sample of over-the-counter nicotine replacement therapy (i.e., nicotine lozenge and nicotine patch) and then provided with a written referral for tobacco dependence treatment.'}, {'id': 'OG002', 'title': 'Referral Only', 'description': 'Participants are provided with a written referral sheet for a local smoking cessation clinic and the New Jersey State Quit Line.\n\nReferral Only: Participants are provided with a written referral for tobacco dependence treatment.'}], 'classes': [{'categories': [{'measurements': [{'value': '5.7', 'spread': '1.3', 'groupId': 'OG000'}, {'value': '6.6', 'spread': '2.1', 'groupId': 'OG001'}, {'value': '6.4', 'spread': '2.0', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '.188', 'groupIds': ['OG000', 'OG001', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'paramValue': '1.728', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': '30 days', 'description': '"Readiness to Quit Ladder" (with 10 non-numbered choices, ranging from 0 to 10 reflecting varying degrees of readiness to quit smoking; higher numbers reflect greater readiness to quit smoking)', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Motivational Interviewing', 'description': '35 minute individual motivational interviewing intervention concluding with a written referral sheet for a local smoking cessation clinic and the New Jersey State Quit Line\n\nMotivational Interviewing: Participants are provided with a 35 minute counseling session designed to increase motivation to quit smoking and then provided with a written referral for tobacco dependence treatment.'}, {'id': 'FG001', 'title': 'Nicotine Replacement Therapy Sampling', 'description': 'Participants are provided with a 2-week supply of nicotine patches and a 2 week supply of nicotine lozenges with a recommendation to try them and are also given a written referral sheet for a local smoking cessation clinic and the New Jersey State Quit Line.\n\nNicotine Replacement Therapy Sampling: Participants are provided with a two-week sample of over-the-counter nicotine replacement therapy (i.e., nicotine lozenge and nicotine patch) and then provided with a written referral for tobacco dependence treatment.'}, {'id': 'FG002', 'title': 'Referral Only', 'description': 'Participants are provided with a written referral sheet for a local smoking cessation clinic and the New Jersey State Quit Line.\n\nReferral Only: Participants are provided with a written referral for tobacco dependence treatment.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '19'}, {'groupId': 'FG001', 'numSubjects': '19'}, {'groupId': 'FG002', 'numSubjects': '20'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '18'}, {'groupId': 'FG001', 'numSubjects': '18'}, {'groupId': 'FG002', 'numSubjects': '17'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '3'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '2'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'BG000'}, {'value': '19', 'groupId': 'BG001'}, {'value': '20', 'groupId': 'BG002'}, {'value': '58', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 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referral for tobacco dependence treatment.'}, {'id': 'BG002', 'title': 'Referral Only', 'description': 'Participants are provided with a written referral sheet for a local smoking cessation clinic and the New Jersey State Quit Line.\n\nReferral Only: Participants are provided with a written referral for tobacco dependence treatment.'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '46.32', 'spread': '12.37', 'groupId': 'BG000'}, {'value': '50.53', 'spread': '7.97', 'groupId': 'BG001'}, {'value': '45.65', 'spread': '10.87', 'groupId': 'BG002'}, {'value': '47.47', 'spread': '10.61', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex/Gender, Customized', 'classes': [{'title': 'Male', 'categories': [{'measurements': [{'value': '11', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '14', 'groupId': 'BG002'}, {'value': '39', 'groupId': 'BG003'}]}]}, {'title': 'Female', 'categories': [{'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}, {'value': '17', 'groupId': 'BG003'}]}]}, {'title': 'Transgender Woman', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}]}]}, {'title': 'Transgender Man', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'White / Latinx', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '6', 'groupId': 'BG003'}]}]}, {'title': 'White / Non-Latinx', 'categories': [{'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}, {'value': '22', 'groupId': 'BG003'}]}]}, {'title': 'Black / Latinx', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}]}]}, {'title': 'Black / Non-Latinx', 'categories': [{'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}, {'value': '22', 'groupId': 'BG003'}]}]}, {'title': 'American Indian / Alaskan Native and Latinx', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}]}]}, {'title': 'Asian', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}]}, {'title': "Don't Know / Refused", 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '4', 'groupId': 'BG003'}]}]}, {'title': 'Other', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}]}]}, {'title': 'American Indian / Alaskan Native and Not Latinx', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '19', 'groupId': 'BG000'}, {'value': '19', 'groupId': 'BG001'}, {'value': '20', 'groupId': 'BG002'}, {'value': '58', 'groupId': 'BG003'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Cigarettes Per day', 'classes': [{'categories': [{'measurements': [{'value': '15.47', 'spread': '6.57', 'groupId': 'BG000'}, {'value': '11.84', 'spread': '10.94', 'groupId': 'BG001'}, {'value': '13.45', 'spread': '6.58', 'groupId': 'BG002'}, {'value': '13.59', 'spread': '8.25', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'cigarettes per day', 'dispersionType': 'STANDARD_DEVIATION'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2019-03-15', 'size': 275742, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2019-09-25T17:22', 'hasProtocol': True}, {'date': '2019-09-27', 'size': 181665, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2019-10-25T10:35', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR'], 'maskingDescription': 'The individual conducting the outcomes assessment is blind to study condition.'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Randomized clinical trial in which participants are randomized to one of three groups.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 58}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-05-30', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-11', 'completionDateStruct': {'date': '2018-10-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-11-13', 'studyFirstSubmitDate': '2018-06-29', 'resultsFirstSubmitDate': '2019-09-27', 'studyFirstSubmitQcDate': '2018-08-06', 'lastUpdatePostDateStruct': {'date': '2019-11-15', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2019-11-13', 'studyFirstPostDateStruct': {'date': '2018-08-08', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2019-11-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-10-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': "Self-reported Serious Quit Attempt Measured Via the 'Quitting Preparation and Actions Questionnaire'", 'timeFrame': '30 days', 'description': 'A self-described "serious" attempt to quit smoking cigarettes since the initial study appointment, measured by the "Quitting Preparation and Actions Questionnaire."'}, {'measure': "Self-reported Treatment Seeking Measured Via the 'Quitting Preparation and Actions Questionnaire'", 'timeFrame': '30 days', 'description': 'Self-reported contact with one of two treatment referrals provided at intervention since the time of the initial study appointment'}], 'secondaryOutcomes': [{'measure': 'Self-reported Cigarettes Per Day', 'timeFrame': '30 days', 'description': 'Self-reported cigarettes smoked per day; abstinence to be biochemically verified with carbon monoxide \\< 5ppm'}, {'measure': 'Importance, Confidence, & Readiness Questionnaire', 'timeFrame': '30 days', 'description': 'Motivation and Self-efficacy for quitting smoking measured via Importance, Confidence, \\& Readiness Questionnaire" (rated on a 0 to 10 scale with higher numbers indicating greater importance, confidence, or readiness to quit)'}, {'measure': 'Readiness to Quit Ladder', 'timeFrame': '30 days', 'description': '"Readiness to Quit Ladder" (with 10 non-numbered choices, ranging from 0 to 10 reflecting varying degrees of readiness to quit smoking; higher numbers reflect greater readiness to quit smoking)'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['tobacco', 'smoking', 'cigarette'], 'conditions': ['Tobacco Smoking']}, 'descriptionModule': {'briefSummary': 'Randomized clinical trial comparing 3 brief interventions designed to increase motivation to quit smoking in socioeconomically disadvantaged smokers.', 'detailedDescription': 'The investigators propose a randomized clinical trial comparing 3 brief interventions designed to increase motivation to quit smoking in socioeconomically disadvantaged smokers. Participants will be randomly assigned to receive a) A brief motivational interviewing intervention, b) A nicotine replacement therapy sampling intervention, or c) A referral-only intervention.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Participants must be between the age of 19 and 65\n* Participants must self-report being a daily smoker and provide biochemical verification of smoking status (expired breath carbon monoxide reading \\>5)\n* Participants must be at socioeconomic disadvantage, defined as receiving services at a New Brunswick, New Jersey based social services agency (i.e., living in New Brunswick Housing Authority-run public housing units or requesting social services from the community social service agency, "Elijah\'s Promise")\n* Participants must be able to speak and read English.\n\nExclusion Criteria:\n\n* Participants may not be taking FDA approved smoking cessation or anti-psychotic medications\n* Participants may not reported medical issues of potential concern to nicotine replacement users (e.g., unstable angina pectoris, myocardial infarction, or significant cardiac arrythmia (including atrial fibrillation) in the past 30 days)\n* Participants may not report pending legal issues with potential to result in incarceration.\n* Participants may not be pregnant or nursing, planning on becoming pregnant in the next two months, and must be using effective birth control.'}, 'identificationModule': {'nctId': 'NCT03620708', 'briefTitle': 'Tobacco and Socioeconomic Disadvantage', 'organization': {'class': 'OTHER', 'fullName': 'Rutgers, The State University of New Jersey'}, 'officialTitle': 'Addressing Tobacco Use Among Those At Socioeconomic Disadvantage', 'orgStudyIdInfo': {'id': 'Pro20170000679'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Motivational Interviewing', 'description': '35 minute individual motivational interviewing intervention concluding with a written referral sheet for a local smoking cessation clinic and the New Jersey State Quit Line', 'interventionNames': ['Behavioral: Motivational Interviewing']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Nicotine Replacement Therapy Sampling', 'description': 'Participants are provided with a 2-week supply of nicotine patches and a 2 week supply of nicotine lozenges with a recommendation to try them and are also given a written referral sheet for a local smoking cessation clinic and the New Jersey State Quit Line.', 'interventionNames': ['Drug: Nicotine Replacement Therapy Sampling']}, {'type': 'OTHER', 'label': 'Referral Only', 'description': 'Participants are provided with a written referral sheet for a local smoking cessation clinic and the New Jersey State Quit Line.', 'interventionNames': ['Behavioral: Referral Only']}], 'interventions': [{'name': 'Motivational Interviewing', 'type': 'BEHAVIORAL', 'description': 'Participants are provided with a 35 minute counseling session designed to increase motivation to quit smoking and then provided with a written referral for tobacco dependence treatment.', 'armGroupLabels': ['Motivational Interviewing']}, {'name': 'Nicotine Replacement Therapy Sampling', 'type': 'DRUG', 'otherNames': ['Nicotine Replacement Therapy'], 'description': 'Participants are provided with a two-week sample of over-the-counter nicotine replacement therapy (i.e., nicotine lozenge and nicotine patch) and then provided with a written referral for tobacco dependence treatment.', 'armGroupLabels': ['Nicotine Replacement Therapy Sampling']}, {'name': 'Referral Only', 'type': 'BEHAVIORAL', 'otherNames': ['Referral'], 'description': 'Participants are provided with a written referral for tobacco dependence treatment.', 'armGroupLabels': ['Referral Only']}]}, 'contactsLocationsModule': {'locations': [{'zip': '08901', 'city': 'New Brunswick', 'state': 'New Jersey', 'country': 'United States', 'facility': 'Division of Addiction Psychiatry', 'geoPoint': {'lat': 40.48622, 'lon': -74.45182}}], 'overallOfficials': [{'name': 'Marc L Steinberg, Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Rutgers Robert Wood Johnson Medical School'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Rutgers, The State University of New Jersey', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Marc L. Steinberg, Ph.D.', 'investigatorAffiliation': 'Rutgers, The State University of New Jersey'}}}}