Ignite Creation Date:
2025-12-25 @ 12:14 AM
Ignite Modification Date:
2026-02-23 @ 1:53 PM
Study NCT ID:
NCT01378858
Status:
COMPLETED
Last Update Posted:
2021-03-11
First Post:
2011-06-21
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Varenicline Smoking Cessation Treatment for Methadone Maintenance Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D014029', 'term': 'Tobacco Use Disorder'}, {'id': 'D055118', 'term': 'Medication Adherence'}, {'id': 'D012907', 'term': 'Smoking'}, {'id': 'D019966', 'term': 'Substance-Related Disorders'}], 'ancestors': [{'id': 'D064419', 'term': 'Chemically-Induced Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D010349', 'term': 'Patient Compliance'}, {'id': 'D010342', 'term': 'Patient Acceptance of Health Care'}, {'id': 'D000074822', 'term': 'Treatment Adherence and Compliance'}, {'id': 'D015438', 'term': 'Health Behavior'}, {'id': 'D001519', 'term': 'Behavior'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000068580', 'term': 'Varenicline'}], 'ancestors': [{'id': 'D001552', 'term': 'Benzazepines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D011810', 'term': 'Quinoxalines'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'snahvi@montefiore.org', 'phone': '718 920 5379', 'title': 'Shadi Nahvi, MD, MS', 'organization': 'Albert Einstein College of Medicine'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': '12 week intervention period, and 12 week post intervention follow up', 'eventGroups': [{'id': 'EG000', 'title': 'Varenicline Treatment as Usual (TAU)', 'description': 'Subjects in the TAU arm will self administer varenicline for 12 weeks.\n\nVarenicline: Varenicline, titrated to 1 mg twice daily, will be given to participants in both study arms for 12 weeks.', 'otherNumAtRisk': 50, 'deathsNumAtRisk': 50, 'otherNumAffected': 50, 'seriousNumAtRisk': 50, 'deathsNumAffected': 0, 'seriousNumAffected': 2}, {'id': 'EG001', 'title': 'Varenicline Directly Observed Therapy', 'description': 'Subjects in the directly observed therapy (DOT) arm will receive varenicline directly administered by methadone clinic nurses 4-6 times per week at the same time as they receive methadone, as well as individually packaged take-home doses for self administration on evenings/weekends.\n\nVarenicline: Varenicline, titrated to 1 mg twice daily, will be given to participants in both study arms for 12 weeks.', 'otherNumAtRisk': 50, 'deathsNumAtRisk': 50, 'otherNumAffected': 50, 'seriousNumAtRisk': 50, 'deathsNumAffected': 0, 'seriousNumAffected': 3}], 'otherEvents': [{'term': 'Change in taste', 'notes': 'Assessed through structured questionnaire, assessing specific symptoms reported in varenicline clinical trials, and open-ended assessment', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 50, 'numAffected': 15}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Dry mouth', 'notes': 'Assessed through structured questionnaire, assessing specific symptoms reported in varenicline clinical trials, and open-ended assessment', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numAffected': 20}, {'groupId': 'EG001', 'numAtRisk': 50, 'numAffected': 24}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Change in appetite', 'notes': 'Assessed through structured questionnaire, assessing specific symptoms reported in varenicline clinical trials, and open-ended assessment', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numAffected': 18}, {'groupId': 'EG001', 'numAtRisk': 50, 'numAffected': 19}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Nausea', 'notes': 'Assessed through structured questionnaire, assessing specific symptoms reported in varenicline clinical trials, and open-ended assessment', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numAffected': 19}, {'groupId': 'EG001', 'numAtRisk': 50, 'numAffected': 27}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Vomiting', 'notes': 'Assessed through structured questionnaire, assessing specific symptoms reported in varenicline clinical trials, and open-ended assessment', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 50, 'numAffected': 13}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Gas', 'notes': 'Assessed through structured questionnaire, assessing specific symptoms reported in varenicline clinical trials, and open-ended assessment', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 50, 'numAffected': 17}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Constipation', 'notes': 'Assessed through structured questionnaire, assessing specific symptoms reported in varenicline clinical trials, and open-ended assessment', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numAffected': 16}, {'groupId': 'EG001', 'numAtRisk': 50, 'numAffected': 24}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Change in concentration', 'notes': 'Assessed through structured questionnaire, assessing specific symptoms reported in varenicline clinical trials, and open-ended assessment', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 50, 'numAffected': 7}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Headache', 'notes': 'Assessed through structured questionnaire, assessing specific symptoms reported in varenicline clinical trials, and open-ended assessment', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 50, 'numAffected': 13}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Fatigue', 'notes': 'Assessed through structured questionnaire, assessing specific symptoms reported in varenicline clinical trials, and open-ended assessment', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 50, 'numAffected': 12}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Insomnia', 'notes': 'Assessed through structured questionnaire, assessing specific symptoms reported in varenicline clinical trials, and open-ended assessment', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numAffected': 18}, {'groupId': 'EG001', 'numAtRisk': 50, 'numAffected': 14}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Dizziness', 'notes': 'Assessed through structured questionnaire, assessing specific symptoms reported in varenicline clinical trials, and open-ended assessment', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 50, 'numAffected': 4}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Irritability', 'notes': 'Assessed through structured questionnaire, assessing specific symptoms reported in varenicline clinical trials, and open-ended assessment', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 50, 'numAffected': 8}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Vivid/more frequent dreams', 'notes': 'Assessed through structured questionnaire, assessing specific symptoms reported in varenicline clinical trials, and open-ended assessment', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 50, 'numAffected': 16}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'seriousEvents': [{'term': 'Incident major depressive episode', 'notes': 'Assessed using the Mini-International Neuropsychiatric Interview 6.0.0', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 50, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Incident psychotic disorder', 'notes': 'Assessed using the Mini-International Neuropsychiatric Interview 6.0.0', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 50, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Suicidal ideation', 'notes': 'Wishes to be dead, or thoughts of killing self, assessed using the Columbia Suicide Severity Scale', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 50, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Varenicline Adherence as Measured by Pill Count', 'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Varenicline Treatment as Usual (TAU)', 'description': 'Subjects in the TAU arm will self administer varenicline for 12 weeks.\n\nVarenicline: Varenicline, titrated to 1 mg twice daily, will be given to participants in both study arms for 12 weeks.'}, {'id': 'OG001', 'title': 'Varenicline Directly Observed Therapy', 'description': 'Subjects in the directly observed therapy (DOT) arm will receive varenicline directly administered by methadone clinic nurses 4-6 times per week at the same time as they receive methadone, as well as individually packaged take-home doses for self administration on evenings/weekends.\n\nVarenicline: Varenicline, titrated to 1 mg twice daily, will be given to participants in both study arms for 12 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '61.8', 'groupId': 'OG000', 'lowerLimit': '55.0', 'upperLimit': '68.6'}, {'value': '78.5', 'groupId': 'OG001', 'lowerLimit': '71.8', 'upperLimit': '85.2'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Weeks 0-1, 1-2, 2-3, 4-6, 7-9, 10-12', 'description': 'Pill count adherence, measured as pills taken divided by pills dispensed, analyzed as a continuous measure', 'unitOfMeasure': 'percentage pills taken/pills dispensed', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Comparison of varenicline TAU and DOT groups'}, {'type': 'SECONDARY', 'title': 'Tobacco Abstinence Biochemically Verified With Expired Carbon Monoxide (CO) < 8 p.p.m. at 12 Weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Varenicline Treatment as Usual (TAU)', 'description': 'Subjects in the TAU arm will self administer varenicline for 12 weeks.\n\nVarenicline: Varenicline, titrated to 1 mg twice daily, will be given to participants in both study arms for 12 weeks.'}, {'id': 'OG001', 'title': 'Varenicline Directly Observed Therapy', 'description': 'Subjects in the directly observed therapy (DOT) arm will receive varenicline directly administered by methadone clinic nurses 4-6 times per week at the same time as they receive methadone, as well as individually packaged take-home doses for self administration on evenings/weekends.\n\nVarenicline: Varenicline, titrated to 1 mg twice daily, will be given to participants in both study arms for 12 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Week 12 of treatment', 'description': 'Number of participants achieving self reported, seven day point prevalence abstinence, biochemically verified with expired carbon monoxide (CO) \\< 8 p.p.m., missing = smoking', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'intent to treat'}, {'type': 'SECONDARY', 'title': 'Tobacco Abstinence Biochemically Verified With Expired Carbon Monoxide (CO) < 8 p.p.m. at 24 Weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Varenicline Treatment as Usual (TAU)', 'description': 'Subjects in the TAU arm will self administer varenicline for 12 weeks.\n\nVarenicline: Varenicline, titrated to 1 mg twice daily, will be given to participants in both study arms for 12 weeks.'}, {'id': 'OG001', 'title': 'Varenicline Directly Observed Therapy', 'description': 'Subjects in the directly observed therapy (DOT) arm will receive varenicline directly administered by methadone clinic nurses 4-6 times per week at the same time as they receive methadone, as well as individually packaged take-home doses for self administration on evenings/weekends.\n\nVarenicline: Varenicline, titrated to 1 mg twice daily, will be given to participants in both study arms for 12 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '24 weeks', 'description': 'Number of participants achieving self reported, seven day point prevalence abstinence, biochemically verified with expired carbon monoxide (CO) \\< 8 p.p.m.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Missing = smoking'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Varenicline Treatment as Usual (TAU)', 'description': 'Subjects in the TAU arm will self administer varenicline for 12 weeks.\n\nVarenicline: Varenicline, titrated to 1 mg twice daily, will be given to participants in both study arms for 12 weeks.'}, {'id': 'FG001', 'title': 'Varenicline Directly Observed Therapy', 'description': 'Subjects in the directly observed therapy (DOT) arm will receive varenicline directly administered by methadone clinic nurses 4-6 times per week at the same time as they receive methadone, as well as individually packaged take-home doses for self administration on evenings/weekends.\n\nVarenicline: Varenicline, titrated to 1 mg twice daily, will be given to participants in both study arms for 12 weeks.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '50'}, {'groupId': 'FG001', 'numSubjects': '50'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '46'}, {'groupId': 'FG001', 'numSubjects': '46'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '4'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '4'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'BG000'}, {'value': '50', 'groupId': 'BG001'}, {'value': '100', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Varenicline Treatment as Usual (TAU)', 'description': 'Subjects in the TAU arm will self administer varenicline for 12 weeks.\n\nVarenicline: Varenicline, titrated to 1 mg twice daily, will be given to participants in both study arms for 12 weeks.'}, {'id': 'BG001', 'title': 'Varenicline Directly Observed Therapy', 'description': 'Subjects in the directly observed therapy (DOT) arm will receive varenicline directly administered by methadone clinic nurses 4-6 times per week at the same time as they receive methadone, as well as individually packaged take-home doses for self administration on evenings/weekends.\n\nVarenicline: Varenicline, titrated to 1 mg twice daily, will be given to participants in both study arms for 12 weeks.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '49', 'groupId': 'BG000', 'lowerLimit': '45', 'upperLimit': '52'}, {'value': '49', 'groupId': 'BG001', 'lowerLimit': '46', 'upperLimit': '53'}, {'value': '49', 'groupId': 'BG002', 'lowerLimit': '45', 'upperLimit': '53'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'years', 'dispersionType': 'INTER_QUARTILE_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '20', 'groupId': 'BG000'}, {'value': '24', 'groupId': 'BG001'}, {'value': '44', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '30', 'groupId': 'BG000'}, {'value': '26', 'groupId': 'BG001'}, {'value': '56', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'Hispanic', 'categories': [{'measurements': [{'value': '22', 'groupId': 'BG000'}, {'value': '22', 'groupId': 'BG001'}, {'value': '44', 'groupId': 'BG002'}]}]}, {'title': 'Black', 'categories': [{'measurements': [{'value': '13', 'groupId': 'BG000'}, {'value': '17', 'groupId': 'BG001'}, {'value': '30', 'groupId': 'BG002'}]}]}, {'title': 'Mutliracial/multiethnic', 'categories': [{'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}]}]}, {'title': 'White', 'categories': [{'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '14', 'groupId': 'BG002'}]}]}, {'title': 'Other', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Cigarettes smoked per day', 'classes': [{'categories': [{'measurements': [{'value': '10', 'groupId': 'BG000', 'lowerLimit': '8', 'upperLimit': '15'}, {'value': '12', 'groupId': 'BG001', 'lowerLimit': '8', 'upperLimit': '20'}, {'value': '10', 'groupId': 'BG002', 'lowerLimit': '8', 'upperLimit': '20'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'cigarettes smoked per day', 'dispersionType': 'INTER_QUARTILE_RANGE'}, {'title': 'Expired carbon monoxide', 'classes': [{'categories': [{'measurements': [{'value': '7', 'groupId': 'BG000', 'lowerLimit': '5', 'upperLimit': '10'}, {'value': '8', 'groupId': 'BG001', 'lowerLimit': '5', 'upperLimit': '10'}, {'value': '7', 'groupId': 'BG002', 'lowerLimit': '5', 'upperLimit': '10'}]}]}], 'paramType': 'MEDIAN', 'description': "A measure of the amount of carbon monoxide on a person's breath, which is checked using a Smokerlyzer monitor (Bedfont Scientific).", 'unitOfMeasure': 'parts per million', 'dispersionType': 'INTER_QUARTILE_RANGE'}, {'title': 'Fagerstrom Test of Nicotine Dependence score', 'classes': [{'categories': [{'measurements': [{'value': '5', 'groupId': 'BG000', 'lowerLimit': '4', 'upperLimit': '6'}, {'value': '5', 'groupId': 'BG001', 'lowerLimit': '4', 'upperLimit': '7'}, {'value': '5', 'groupId': 'BG002', 'lowerLimit': '4', 'upperLimit': '6'}]}]}], 'paramType': 'MEDIAN', 'description': "In scoring the Fagerstrom Test for Nicotine Dependence, yes/no items are scored from 0 to 1 and multiple-choice items are scored from 0 to 3. The items are summed to yield a total score of 0-10. The higher the total Fagerström score, the more intense is the patient's physical dependence on nicotine.", 'unitOfMeasure': 'units on a scale', 'dispersionType': 'INTER_QUARTILE_RANGE'}, {'title': 'Ladder of change score', 'classes': [{'categories': [{'measurements': [{'value': '8', 'groupId': 'BG000', 'lowerLimit': '7', 'upperLimit': '8'}, {'value': '8', 'groupId': 'BG001', 'lowerLimit': '6', 'upperLimit': '8'}, {'value': '8', 'groupId': 'BG002', 'lowerLimit': '6', 'upperLimit': '8'}]}]}], 'paramType': 'MEDIAN', 'description': 'The Ladder is a continuous measure of motivation to change smoking where a score of 1 indicates low readiness to quit smoking and a score of 10 indicates high readiness to quit smoking.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'INTER_QUARTILE_RANGE'}, {'title': 'Quit importance', 'classes': [{'categories': [{'measurements': [{'value': '10', 'groupId': 'BG000', 'lowerLimit': '9', 'upperLimit': '10'}, {'value': '10', 'groupId': 'BG001', 'lowerLimit': '9', 'upperLimit': '10'}, {'value': '10', 'groupId': 'BG002', 'lowerLimit': '9', 'upperLimit': '10'}]}]}], 'paramType': 'MEDIAN', 'description': 'Quit importance measures importance of quitting smoking for participants on a scale from 1 to 10 where 1 is not important and 10 is highly important', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'INTER_QUARTILE_RANGE'}, {'title': 'Quit confidence', 'classes': [{'categories': [{'measurements': [{'value': '7', 'groupId': 'BG000', 'lowerLimit': '5', 'upperLimit': '10'}, {'value': '8', 'groupId': 'BG001', 'lowerLimit': '6', 'upperLimit': '10'}, {'value': '8', 'groupId': 'BG002', 'lowerLimit': '5', 'upperLimit': '10'}]}]}], 'paramType': 'MEDIAN', 'description': 'Quit confidence measures confidence in quitting smoking for participants on a scale from 1 to 10 where 1 is not confident at all and 10 is highly confident', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'INTER_QUARTILE_RANGE'}, {'title': 'Any past quit attempts', 'classes': [{'categories': [{'measurements': [{'value': '39', 'groupId': 'BG000'}, {'value': '42', 'groupId': 'BG001'}, {'value': '81', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Preferred brand of cigarettes menthol', 'classes': [{'categories': [{'measurements': [{'value': '46', 'groupId': 'BG000'}, {'value': '42', 'groupId': 'BG001'}, {'value': '88', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Number of participants with unstable housing', 'classes': [{'categories': [{'measurements': [{'value': '27', 'groupId': 'BG000'}, {'value': '37', 'groupId': 'BG001'}, {'value': '64', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'description': 'Living in a shelter, temporary housing, hotel/motel, or on the street', 'unitOfMeasure': 'participants'}, {'title': 'Number of participants currently employed', 'classes': [{'categories': [{'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '20', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Number of participants married or living with a partner', 'classes': [{'categories': [{'measurements': [{'value': '19', 'groupId': 'BG000'}, {'value': '26', 'groupId': 'BG001'}, {'value': '45', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Lifetime major depressive episode', 'classes': [{'categories': [{'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '21', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Assessed using the Mini-International Neuropsychiatric Interview 6.0.0. The Mini-International Neuropsychiatric Interview (M.I.N.I.) is a short structured diagnostic interview for assessing DSM-IV and ICD-10 psychiatric disorders.', 'unitOfMeasure': 'Participants'}, {'title': 'Lifetime psychotic disorder', 'classes': [{'categories': [{'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Assessed using the Mini-International Neuropsychiatric Interview 6.0.0. The Mini-International Neuropsychiatric Interview (M.I.N.I.) is a short structured diagnostic interview for assessing DSM-IV and ICD-10 psychiatric disorders.', 'unitOfMeasure': 'Participants'}, {'title': 'Lifetime suicide attempt', 'classes': [{'categories': [{'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '15', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Assessed using the Columbia Suicide Severity Scale, a structured interview which assesses suicidal ideation, plans, intent, and behavior', 'unitOfMeasure': 'Participants'}, {'title': 'Severe global psychiatric symptoms', 'classes': [{'categories': [{'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '17', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Assessed using the Brief Symptom Inventory Global Severity Index, a 53-item self report scale, with scores dichotomized at a T score ≥ 63', 'unitOfMeasure': 'Participants'}, {'title': 'Currently receiving psychiatric treatment', 'classes': [{'categories': [{'measurements': [{'value': '19', 'groupId': 'BG000'}, {'value': '18', 'groupId': 'BG001'}, {'value': '37', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Participants with COPD/Asthma', 'classes': [{'categories': [{'measurements': [{'value': '15', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '30', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Participants with HIV/AIDS', 'classes': [{'categories': [{'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '20', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Median duration methadone maintenance', 'classes': [{'categories': [{'measurements': [{'value': '5', 'groupId': 'BG000', 'lowerLimit': '3.3', 'upperLimit': '8.9'}, {'value': '5.6', 'groupId': 'BG001', 'lowerLimit': '3.3', 'upperLimit': '8.9'}, {'value': '5.6', 'groupId': 'BG002', 'lowerLimit': '3.3', 'upperLimit': '8.9'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'years', 'dispersionType': 'INTER_QUARTILE_RANGE'}, {'title': 'Median methadone dose', 'classes': [{'categories': [{'measurements': [{'value': '92', 'groupId': 'BG000', 'lowerLimit': '60', 'upperLimit': '120'}, {'value': '83.5', 'groupId': 'BG001', 'lowerLimit': '70', 'upperLimit': '110'}, {'value': '90', 'groupId': 'BG002', 'lowerLimit': '61.5', 'upperLimit': '112.5'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'mg', 'dispersionType': 'INTER_QUARTILE_RANGE'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 100}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-03', 'completionDateStruct': {'date': '2015-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-03-09', 'studyFirstSubmitDate': '2011-06-21', 'resultsFirstSubmitDate': '2020-10-19', 'studyFirstSubmitQcDate': '2011-06-22', 'lastUpdatePostDateStruct': {'date': '2021-03-11', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2021-03-09', 'studyFirstPostDateStruct': {'date': '2011-06-23', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2021-03-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2015-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Varenicline Adherence as Measured by Pill Count', 'timeFrame': 'Weeks 0-1, 1-2, 2-3, 4-6, 7-9, 10-12', 'description': 'Pill count adherence, measured as pills taken divided by pills dispensed, analyzed as a continuous measure'}], 'secondaryOutcomes': [{'measure': 'Tobacco Abstinence Biochemically Verified With Expired Carbon Monoxide (CO) < 8 p.p.m. at 12 Weeks', 'timeFrame': 'Week 12 of treatment', 'description': 'Number of participants achieving self reported, seven day point prevalence abstinence, biochemically verified with expired carbon monoxide (CO) \\< 8 p.p.m., missing = smoking'}, {'measure': 'Tobacco Abstinence Biochemically Verified With Expired Carbon Monoxide (CO) < 8 p.p.m. at 24 Weeks', 'timeFrame': '24 weeks', 'description': 'Number of participants achieving self reported, seven day point prevalence abstinence, biochemically verified with expired carbon monoxide (CO) \\< 8 p.p.m.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Smoking', 'Substance-Related Disorders', 'medication adherence', 'Methadone'], 'conditions': ['Tobacco Use Disorder', 'Medication Adherence']}, 'referencesModule': {'references': [{'pmid': '37142273', 'type': 'DERIVED', 'citation': 'Livingstone-Banks J, Fanshawe TR, Thomas KH, Theodoulou A, Hajizadeh A, Hartman L, Lindson N. Nicotine receptor partial agonists for smoking cessation. Cochrane Database Syst Rev. 2023 May 5;5(5):CD006103. doi: 10.1002/14651858.CD006103.pub8.'}, {'pmid': '32857445', 'type': 'DERIVED', 'citation': 'Nahvi S, Adams TR, Ning Y, Zhang C, Arnsten JH. Effect of varenicline directly observed therapy versus varenicline self-administered therapy on varenicline adherence and smoking cessation in methadone-maintained smokers: a randomized controlled trial. Addiction. 2021 Apr;116(4):902-913. doi: 10.1111/add.15240. Epub 2020 Oct 13.'}, {'pmid': '24928218', 'type': 'DERIVED', 'citation': 'Nahvi S, Segal KS, Litwin AH, Arnsten JH. Rationale and design of a randomized controlled trial of varenicline directly observed therapy delivered in methadone clinics. Addict Sci Clin Pract. 2014 Jun 13;9(1):9. doi: 10.1186/1940-0640-9-9.'}]}, 'descriptionModule': {'briefSummary': 'This randomized trial will evaluate whether varenicline directly observed therapy provided at a methadone clinic is more efficacious than self-administered varenicline for promoting smoking cessation and enhancing adherence.', 'detailedDescription': "There is a marked prevalence of tobacco use and tobacco-related disease among methadone maintenance patients. Varenicline's demonstrated efficacy may not be generalizable to methadone maintained smokers because of poor adherence, which is highly prevalent among drug users. Adherence to smoking cessation medication is strongly associated with cessation, and is one of the few factors shown to increase cessation among methadone maintained smokers, but strategies to promote smoking cessation medication adherence have not been evaluated in methadone patients. Based on the Information, Motivation, and Behavior model, the investigators plan a directly observed therapy (DOT)-based intervention targeting behavioral skills necessary for optimal adherence. Because methadone clinic-based DOT interventions have been shown to improve medication adherence and clinical outcomes in HIV and TB, the investigators plan to determine in a randomized trial whether DOT varenicline provided at a methadone clinic is more efficacious than self-administered varenicline for promoting smoking cessation and enhancing adherence. The investigators will also evaluate moderating effects of drug and alcohol use and psychiatric symptoms on DOT effects. The investigators hypothesize subjects in the mDOT arm will have greater 7 day point prevalence abstinence at 12 weeks, reduction in cigarettes/day, time to first daily cigarette, ≥ 24 hour quit attempts, and 7 day point prevalence abstinence at 24 weeks compared to subjects receiving self administered varenicline. The investigators also hypothesize that adherence in the mDOT arm will be higher than in the TAU arm. Lastly the investigators hypothesize that ongoing illicit drug use and psychiatric symptoms will moderate the effect of mDOT on adherence."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age 18 years or older\n* English speaking\n* Smoked at least 100 cigarettes/lifetime\n* Smoke 5 or more cigarettes per day\n* Interested in quitting smoking (preparation or contemplation stage of change)\n* Enrolled in Einstein/Montefiore methadone program for 12 weeks or more\n* Receiving methadone in clinic three, four, five or six times per week\n* No more than 2 methadone clinic misses in prior 14 days\n* Agree to use contraception for the duration of the trial (among women with reproductive potential)\n* Willing to participate in all study components\n* Able to provide informed consent\n\nExclusion Criteria:\n\n* Serious or unstable HIV/AIDS, liver, cardiovascular, or pulmonary disease\n* Psychiatric instability\n* Women who are pregnant, breastfeeding, or contemplating pregnancy\n* Creatinine clearance \\<30 mL/min'}, 'identificationModule': {'nctId': 'NCT01378858', 'briefTitle': 'Varenicline Smoking Cessation Treatment for Methadone Maintenance Patients', 'organization': {'class': 'OTHER', 'fullName': 'Albert Einstein College of Medicine'}, 'officialTitle': 'Varenicline Smoking Cessation Treatment for Methadone Maintenance Patients', 'orgStudyIdInfo': {'id': '2010-279'}, 'secondaryIdInfos': [{'id': 'K23DA025736', 'link': 'https://reporter.nih.gov/quickSearch/K23DA025736', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Varenicline treatment as usual (TAU)', 'description': 'Subjects in the TAU arm will self administer varenicline for 12 weeks.', 'interventionNames': ['Drug: Varenicline']}, {'type': 'EXPERIMENTAL', 'label': 'Varenicline directly observed therapy', 'description': 'Subjects in the directly observed therapy (DOT) arm will receive varenicline directly administered by methadone clinic nurses 4-6 times per week at the same time as they receive methadone, as well as individually packaged take-home doses for self administration on evenings/weekends.', 'interventionNames': ['Drug: Varenicline']}], 'interventions': [{'name': 'Varenicline', 'type': 'DRUG', 'otherNames': ['Chantix'], 'description': 'Varenicline, titrated to 1 mg twice daily, will be given to participants in both study arms for 12 weeks.', 'armGroupLabels': ['Varenicline directly observed therapy', 'Varenicline treatment as usual (TAU)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10467', 'city': 'The Bronx', 'state': 'New York', 'country': 'United States', 'facility': 'Albert Einstein College of Medicine', 'geoPoint': {'lat': 40.84985, 'lon': -73.86641}}], 'overallOfficials': [{'name': 'Shadi Nahvi, M.D., M.S.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Albert Einstein College of Medicine'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Albert Einstein College of Medicine', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institute on Drug Abuse (NIDA)', 'class': 'NIH'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor', 'investigatorFullName': 'Shadi Nahvi', 'investigatorAffiliation': 'Albert Einstein College of Medicine'}}}}