Ignite Creation Date:
2025-12-25 @ 12:14 AM
Ignite Modification Date:
2025-12-25 @ 10:15 PM
Study NCT ID:
NCT01928758
Status:
COMPLETED
Last Update Posted:
2019-06-28
First Post:
2013-08-21
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Reduced Nicotine Cigarettes in Smokers With Mood and Anxiety Disorders
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D014029', 'term': 'Tobacco Use Disorder'}, {'id': 'D012907', 'term': 'Smoking'}], 'ancestors': [{'id': 'D019966', 'term': 'Substance-Related Disorders'}, {'id': 'D064419', 'term': 'Chemically-Induced Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D001519', 'term': 'Behavior'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D009538', 'term': 'Nicotine'}], 'ancestors': [{'id': 'D012991', 'term': 'Solanaceous Alkaloids'}, {'id': 'D000470', 'term': 'Alkaloids'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D011725', 'term': 'Pyridines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'jfoulds@psu.edu', 'phone': '717-531-3504', 'title': 'Jonathan Foulds', 'organization': 'Penn State College of Medicine'}, 'certainAgreement': {'piSponsorEmployee': True}, 'limitationsAndCaveats': {'description': 'The sample size was not reached due to a shortage of study cigarette inventory.'}}, 'adverseEventsModule': {'timeFrame': 'All randomized participants throughout the entire 33 weeks of the trial.', 'description': 'Adverse events (AEs) were systematically collected at each study visit by asking participants about any changes in their physical or mental health or if they needed to seek immediate medical care at an emergency room or hospital.', 'eventGroups': [{'id': 'EG000', 'title': 'Reduced Nicotine Content Cigarettes', 'description': 'The experimental group will smoke cigarettes with gradually Reduced Nicotine Content (11.6, 8.6, 4.0, 1.8, 0.9 and 0.3 mg per cigarette) cigarettes, with each nicotine level smoked for 3 weeks, except the lowest level which continues for 6 weeks\n\nReduced Nicotine Content Cigarettes: Research cigarettes will have gradually reduced nicotine content', 'otherNumAtRisk': 94, 'deathsNumAtRisk': 94, 'otherNumAffected': 70, 'seriousNumAtRisk': 94, 'deathsNumAffected': 0, 'seriousNumAffected': 7}, {'id': 'EG001', 'title': 'Usual Nicotine Content Cigarettes', 'description': "Research cigarettes with a nicotine content similar to participant's usual brand of cigarettes (around 11.6mg)\n\nUsual Nicotine Content Cigarettes: Usual Nicotine Content Cigarettes", 'otherNumAtRisk': 94, 'deathsNumAtRisk': 94, 'otherNumAffected': 72, 'seriousNumAtRisk': 94, 'deathsNumAffected': 0, 'seriousNumAffected': 10}], 'otherEvents': [{'term': 'Allergic rhinitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 94, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 94, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Anxiety', 'stats': [{'groupId': 'EG000', 'numAtRisk': 94, 'numEvents': 28, 'numAffected': 22}, {'groupId': 'EG001', 'numAtRisk': 94, 'numEvents': 22, 'numAffected': 19}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 94, 'numEvents': 4, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 94, 'numEvents': 6, 'numAffected': 6}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 94, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 94, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Depression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 94, 'numEvents': 39, 'numAffected': 30}, {'groupId': 'EG001', 'numAtRisk': 94, 'numEvents': 26, 'numAffected': 21}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Flu like symptoms', 'stats': [{'groupId': 'EG000', 'numAtRisk': 94, 'numEvents': 9, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 94, 'numEvents': 14, 'numAffected': 11}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 94, 'numEvents': 9, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 94, 'numEvents': 5, 'numAffected': 4}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 94, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 94, 'numEvents': 7, 'numAffected': 7}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Irritability', 'stats': [{'groupId': 'EG000', 'numAtRisk': 94, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 94, 'numEvents': 7, 'numAffected': 6}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Pain in extremity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 94, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 94, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Respiratory, thoracic and mediastinal disorders - Other', 'stats': [{'groupId': 'EG000', 'numAtRisk': 94, 'numEvents': 13, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 94, 'numEvents': 15, 'numAffected': 13}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Suicidal ideation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 94, 'numEvents': 14, 'numAffected': 14}, {'groupId': 'EG001', 'numAtRisk': 94, 'numEvents': 11, 'numAffected': 11}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Surgical and medical procedures - Other', 'stats': [{'groupId': 'EG000', 'numAtRisk': 94, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 94, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Upper respiratory infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 94, 'numEvents': 32, 'numAffected': 29}, {'groupId': 'EG001', 'numAtRisk': 94, 'numEvents': 30, 'numAffected': 24}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}], 'seriousEvents': [{'term': 'Appendicitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 94, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 94, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Cardiac disorders - Other', 'notes': 'Blocked artery', 'stats': [{'groupId': 'EG000', 'numAtRisk': 94, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 94, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Depression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 94, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 94, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Dyspnea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 94, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 94, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Endocarditis infective', 'stats': [{'groupId': 'EG000', 'numAtRisk': 94, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 94, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 94, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 94, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Heart failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 94, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 94, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Infections and infestations - Other', 'notes': 'Lung and leg infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 94, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 94, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Injury, poisoning and procedural complications - Other', 'notes': 'Accidental drug overdose', 'stats': [{'groupId': 'EG000', 'numAtRisk': 94, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 94, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Musculoskeletal and connective tissue disorder - Other', 'notes': 'Rhabdomyolysis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 94, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 94, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Psychiatric disorders - Other', 'notes': 'Drug relapse', 'stats': [{'groupId': 'EG000', 'numAtRisk': 94, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 94, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Respiratory, thoracic and mediastinal disorders - Other', 'stats': [{'groupId': 'EG000', 'numAtRisk': 94, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 94, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Suicidal ideation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 94, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 94, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Surgical and medical procedures - Other', 'notes': 'Dog bite requiring surgery', 'stats': [{'groupId': 'EG000', 'numAtRisk': 94, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 94, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Upper respiratory infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 94, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 94, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Acute coronary syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 94, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 94, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Aortic valve disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 94, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 94, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Plasma Cotinine Concentration', 'denoms': [{'units': 'Participants', 'counts': [{'value': '66', 'groupId': 'OG000'}, {'value': '72', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Reduced Nicotine Content Cigarettes', 'description': 'The experimental group will smoke cigarettes with gradually Reduced Nicotine Content (11.6, 7.4, 3.3, 1.4, 0.7 and 0.2 mg per cigarette) cigarettes, with each nicotine level smoked for 3 weeks, except the lowest level which continues for 6 weeks\n\nReduced Nicotine Content Cigarettes: Research cigarettes will have gradually reduced nicotine content'}, {'id': 'OG001', 'title': 'Usual Nicotine Content Cigarettes', 'description': "Research cigarettes with a nicotine content similar to participant's usual brand of cigarettes (around 11.6mg)\n\nUsual Nicotine Content Cigarettes: Usual Nicotine Content Cigarettes"}], 'classes': [{'categories': [{'measurements': [{'value': '82.8', 'spread': '154.3', 'groupId': 'OG000'}, {'value': '259.0', 'spread': '151.3', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-175.7', 'ciLowerLimit': '-218.3', 'ciUpperLimit': '-133.1', 'pValueComment': 'Complete case analysis', 'estimateComment': 'The direction of comparison is reduced nicotine content vs. usual nicotine content cigarette treatment group.', 'statisticalMethod': 'Regression, Linear', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'Model was adjusted for baseline cotinine after smoking usual nicotine content cigarettes for 2-weeks.'}], 'paramType': 'MEAN', 'timeFrame': 'Measured at the end of the last 3 weeks of randomization trial phase', 'description': 'Plasma cotinine is a measure of daily nicotine exposure. Samples were measured in ng/mL.', 'unitOfMeasure': 'ng/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Randomized trial phase completers with non-missing values for the outcome at both time points being used in the regression (complete case analysis).'}, {'type': 'SECONDARY', 'title': 'Quick Inventory of Depressive Symptomatology', 'denoms': [{'units': 'Participants', 'counts': [{'value': '69', 'groupId': 'OG000'}, {'value': '72', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Reduced Nicotine Content Cigarettes', 'description': 'The experimental group will smoke cigarettes with gradually Reduced Nicotine Content (11.6, 7.4, 3.3, 1.4, 0.7 and 0.2 mg per cigarette) cigarettes, with each nicotine level smoked for 3 weeks, except the lowest level which continues for 6 weeks\n\nReduced Nicotine Content Cigarettes: Research cigarettes will have gradually reduced nicotine content'}, {'id': 'OG001', 'title': 'Usual Nicotine Content Cigarettes', 'description': "Research cigarettes with a nicotine content similar to participant's usual brand of cigarettes (around 11.6mg)\n\nUsual Nicotine Content Cigarettes: Usual Nicotine Content Cigarettes"}], 'classes': [{'categories': [{'measurements': [{'value': '5.5', 'spread': '4.3', 'groupId': 'OG000'}, {'value': '5.3', 'spread': '3.9', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.16', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.69', 'ciLowerLimit': '-0.28', 'ciUpperLimit': '1.65', 'pValueComment': 'Complete case analysis', 'estimateComment': 'The direction of comparison is reduced nicotine content vs. usual nicotine content cigarette treatment group', 'statisticalMethod': 'Regression, Linear', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'Model was adjusted for baseline score after smoking usual nicotine content cigarettes for 2 weeks'}], 'paramType': 'MEAN', 'timeFrame': 'Measured at the end of the last 3 weeks of randomization trial phase', 'description': 'A 16-item scale on depression symptoms. The scale range is 0-27 where 0 = Least Severe and 27 = Most Severe.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Randomized trial phase completers with non-missing values for the outcome at both time points being used in the regression (complete case analysis).'}, {'type': 'SECONDARY', 'title': 'Perceived Stress Scale', 'denoms': [{'units': 'Participants', 'counts': [{'value': '69', 'groupId': 'OG000'}, {'value': '74', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Reduced Nicotine Content Cigarettes', 'description': 'The experimental group will smoke cigarettes with gradually Reduced Nicotine Content (11.6, 7.4, 3.3, 1.4, 0.7 and 0.2 mg per cigarette) cigarettes, with each nicotine level smoked for 3 weeks, except the lowest level which continues for 6 weeks\n\nReduced Nicotine Content Cigarettes: Research cigarettes will have gradually reduced nicotine content'}, {'id': 'OG001', 'title': 'Usual Nicotine Content Cigarettes', 'description': "Research cigarettes with a nicotine content similar to participant's usual brand of cigarettes (around 11.6mg)\n\nUsual Nicotine Content Cigarettes: Usual Nicotine Content Cigarettes"}], 'classes': [{'categories': [{'measurements': [{'value': '15.0', 'spread': '7.6', 'groupId': 'OG000'}, {'value': '15.1', 'spread': '7.8', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.67', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.38', 'ciLowerLimit': '-1.40', 'ciUpperLimit': '2.16', 'pValueComment': 'Complete case analysis', 'estimateComment': 'The direction of comparison is reduced nicotine content vs. usual nicotine content cigarette treatment group.', 'statisticalMethod': 'Regression, Linear', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'Model was adjusted for baseline score after smoking usual nicotine content cigarettes for 2 weeks'}], 'paramType': 'MEAN', 'timeFrame': 'Measured at the end of the last 3 weeks of randomization trial phase', 'description': '10-item questionnaire measuring the degree to which life situations are appraised stressful. Scale range is 0-40. Higher scores indicate more stress.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Randomized trial phase completers with non-missing values for the outcome at both time points being used in the regression (complete case analysis).'}, {'type': 'SECONDARY', 'title': 'Minnesota Nicotine Withdrawal Scale', 'denoms': [{'units': 'Participants', 'counts': [{'value': '69', 'groupId': 'OG000'}, {'value': '74', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Reduced Nicotine Content Cigarettes', 'description': 'The experimental group will smoke cigarettes with gradually Reduced Nicotine Content (11.6, 7.4, 3.3, 1.4, 0.7 and 0.2 mg per cigarette) cigarettes, with each nicotine level smoked for 3 weeks, except the lowest level which continues for 6 weeks\n\nReduced Nicotine Content Cigarettes: Research cigarettes will have gradually reduced nicotine content'}, {'id': 'OG001', 'title': 'Usual Nicotine Content Cigarettes', 'description': "Research cigarettes with a nicotine content similar to participant's usual brand of cigarettes (around 11.6mg)\n\nUsual Nicotine Content Cigarettes: Usual Nicotine Content Cigarettes"}], 'classes': [{'categories': [{'measurements': [{'value': '8.1', 'spread': '6.8', 'groupId': 'OG000'}, {'value': '9.0', 'spread': '5.9', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.65', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.31', 'ciLowerLimit': '-1.68', 'ciUpperLimit': '1.05', 'pValueComment': 'Complete case analysis', 'estimateComment': 'The direction of comparison is reduced nicotine content vs. usual nicotine content cigarette treatment group', 'statisticalMethod': 'Regression, Linear', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'Model was adjusted for baseline score after smoking usual nicotine content cigarettes for 2 weeks'}], 'paramType': 'MEAN', 'timeFrame': 'Measured at the end of the last 3 weeks of randomization trial phase', 'description': 'This 8-item scale measures nicotine withdrawal symptoms and the scale range is from 0-32. Higher scores indicate higher severity.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Randomized trial phase completers with non-missing values for the outcome at both time points being used in the regression (complete case analysis).'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Intention to Quit Smoking', 'denoms': [{'units': 'Participants', 'counts': [{'value': '69', 'groupId': 'OG000'}, {'value': '74', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Reduced Nicotine Content Cigarettes', 'description': 'The experimental group will smoke cigarettes with gradually Reduced Nicotine Content (11.6, 7.4, 3.3, 1.4, 0.7 and 0.2 mg per cigarette) cigarettes, with each nicotine level smoked for 3 weeks, except the lowest level which continues for 6 weeks\n\nReduced Nicotine Content Cigarettes: Research cigarettes will have gradually reduced nicotine content'}, {'id': 'OG001', 'title': 'Usual Nicotine Content Cigarettes', 'description': 'Research cigarettes with a usual nicotine content (around 11.6mg per cigarette)\n\nUsual Nicotine Content Cigarettes: Usual Nicotine Content Cigarettes'}], 'classes': [{'categories': [{'measurements': [{'value': '33', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'At end of 18-week randomized trial phase', 'description': 'Smokers assigned to the reduced nicotine content cigarette group may have lower perceived dependence and be more likely to report intention to quit smoking', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants who attended the visit at the end of the 18-week randomized trial phase'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Abstinence From Smoking', 'denoms': [{'units': 'Participants', 'counts': [{'value': '94', 'groupId': 'OG000'}, {'value': '94', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Reduced Nicotine Content Cigarettes', 'description': 'The experimental group will smoke cigarettes with gradually Reduced Nicotine Content (11.6, 7.4, 3.3, 1.4, 0.7 and 0.2 mg per cigarette) cigarettes, with each nicotine level smoked for 3 weeks, except the lowest level which continues for 6 weeks\n\nReduced Nicotine Content Cigarettes: Research cigarettes will have gradually reduced nicotine content'}, {'id': 'OG001', 'title': 'Usual Nicotine Content Cigarettes', 'description': "Research cigarettes with a nicotine content similar to participant's usual brand of cigarettes (around 11.6mg)\n\nUsual Nicotine Content Cigarettes: Usual Nicotine Content Cigarettes"}], 'classes': [{'categories': [{'measurements': [{'value': '17', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Follow-up appointment 30 weeks after randomization (12 weeks after last visit of randomized trial phase).', 'description': 'Smokers assigned to reduced nicotine content cigarettes will be more likely to successfully abstain from smoking at the end of the trial, based on all randomized participants, defined as no cigarette use in past 7 days, verified by exhaled carbon monoxide \\<10ppm.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Reduced Nicotine Content Cigarettes', 'description': 'The experimental group will smoke cigarettes with gradually Reduced Nicotine Content (11.6, 7.4, 3.3, 1.4, 0.7 and 0.2 mg per cigarette) cigarettes, with each nicotine level smoked for 3 weeks, except the lowest level which continues for 6 weeks\n\nReduced Nicotine Content Cigarettes: Research cigarettes will have gradually reduced nicotine content'}, {'id': 'FG001', 'title': 'Usual Nicotine Content Cigarettes', 'description': "Research cigarettes with a nicotine content similar to participant's usual brand of cigarettes (around 11.6mg)\n\nUsual Nicotine Content Cigarettes: Usual Nicotine Content Cigarettes"}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '94'}, {'groupId': 'FG001', 'numSubjects': '94'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '69'}, {'groupId': 'FG001', 'numSubjects': '74'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '25'}, {'groupId': 'FG001', 'numSubjects': '20'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '14'}, {'groupId': 'FG001', 'numSubjects': '9'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '2'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '5'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '4'}]}]}], 'preAssignmentDetails': '27 participants attended Visit 1 and consented but did not meet final eligibility criteria. The remaining participants (n=218) began a baseline phase during which 30 participants were lost to follow up or withdrawn from the study before being randomized to the study intervention. 188 participants were randomized into an intervention.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '94', 'groupId': 'BG000'}, {'value': '94', 'groupId': 'BG001'}, {'value': '188', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Reduced Nicotine Content Cigarettes', 'description': 'The experimental group will smoke cigarettes with gradually Reduced Nicotine Content (11.6, 7.4, 3.3, 1.4, 0.7 and 0.2 mg per cigarette) cigarettes, with each nicotine level smoked for 3 weeks, except the lowest level which continues for 6 weeks\n\nReduced Nicotine Content Cigarettes: Research cigarettes will have gradually reduced nicotine content'}, {'id': 'BG001', 'title': 'Usual Nicotine Content Cigarettes', 'description': "Research cigarettes with a nicotine content similar to participant's usual brand of cigarettes (around 11.6mg)\n\nUsual Nicotine Content Cigarettes: Usual Nicotine Content Cigarettes"}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '43.3', 'spread': '11.7', 'groupId': 'BG000'}, {'value': '43.1', 'spread': '13.3', 'groupId': 'BG001'}, {'value': '43.2', 'spread': '12.5', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '60', 'groupId': 'BG000'}, {'value': '54', 'groupId': 'BG001'}, {'value': '114', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '34', 'groupId': 'BG000'}, {'value': '40', 'groupId': 'BG001'}, {'value': '74', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '87', 'groupId': 'BG000'}, {'value': '93', 'groupId': 'BG001'}, {'value': '180', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'Caucasian/white', 'categories': [{'measurements': [{'value': '70', 'groupId': 'BG000'}, {'value': '76', 'groupId': 'BG001'}, {'value': '146', 'groupId': 'BG002'}]}]}, {'title': 'African American/black', 'categories': [{'measurements': [{'value': '15', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '26', 'groupId': 'BG002'}]}]}, {'title': 'Asian', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}]}, {'title': 'Native Hawaiian or Pacific Island', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}, {'title': 'American Indian/Alaskan native', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}]}, {'title': 'Other', 'categories': [{'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '11', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '94', 'groupId': 'BG000'}, {'value': '94', 'groupId': 'BG001'}, {'value': '188', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Menthol smoker', 'classes': [{'categories': [{'measurements': [{'value': '38', 'groupId': 'BG000'}, {'value': '36', 'groupId': 'BG001'}, {'value': '74', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Quick Inventory of Depressive Symptomatology', 'classes': [{'categories': [{'measurements': [{'value': '5.5', 'spread': '4.8', 'groupId': 'BG000'}, {'value': '6.3', 'spread': '4.3', 'groupId': 'BG001'}, {'value': '5.9', 'spread': '4.5', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'The 16-item scale uses a continuous score and the scale range is 0-27 where 0 = Least Severe and 27 = Most Severe.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Perceived Stress Scale', 'classes': [{'categories': [{'measurements': [{'value': '16.0', 'spread': '7.5', 'groupId': 'BG000'}, {'value': '17.1', 'spread': '8.2', 'groupId': 'BG001'}, {'value': '16.5', 'spread': '7.9', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': '10-item version was used. Scale range is 0-40. Higher scores indicate more stress.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Overall Anxiety Severity and Impairment Scale', 'classes': [{'categories': [{'measurements': [{'value': '4.9', 'spread': '4.1', 'groupId': 'BG000'}, {'value': '5.7', 'spread': '4.3', 'groupId': 'BG001'}, {'value': '5.3', 'spread': '4.2', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'The OASIS is a 5-item scale to measure overall anxiety severity and impairment. The range is 0-20 where higher scores indicate higher anxiety.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Kessler-6 Scale', 'classes': [{'categories': [{'measurements': [{'value': '5.6', 'spread': '5.4', 'groupId': 'BG000'}, {'value': '6.5', 'spread': '5.1', 'groupId': 'BG001'}, {'value': '6.1', 'spread': '5.3', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'The Kessler-6 Scale is a 6-item scale with a total possible score range from 0-24 used to define serious psychological distress. Higher scores indicate more distress.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Cigarettes per day', 'classes': [{'categories': [{'measurements': [{'value': '20.2', 'spread': '10.7', 'groupId': 'BG000'}, {'value': '21.6', 'spread': '10.6', 'groupId': 'BG001'}, {'value': '20.9', 'spread': '10.7', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'cigarettes', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Exhaled Carbon Monoxide', 'classes': [{'categories': [{'measurements': [{'value': '29.4', 'spread': '17.7', 'groupId': 'BG000'}, {'value': '29.1', 'spread': '15.1', 'groupId': 'BG001'}, {'value': '29.3', 'spread': '16.4', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'parts per million', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Plasma Cotinine', 'classes': [{'categories': [{'measurements': [{'value': '245.7', 'spread': '137.2', 'groupId': 'BG000'}, {'value': '255.9', 'spread': '145.5', 'groupId': 'BG001'}, {'value': '250.9', 'spread': '141.2', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'Cotinine values below the assay Limit of Detection (LOD) are imputed using a common substitution formula (LOD/ square root of 2), which in the case of plasma cotinine equals 3 ng/mL.', 'unitOfMeasure': 'ng/mL', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Minnesota Nicotine Withdrawal Scale', 'classes': [{'categories': [{'measurements': [{'value': '9.9', 'spread': '7.3', 'groupId': 'BG000'}, {'value': '10.5', 'spread': '6.3', 'groupId': 'BG001'}, {'value': '10.2', 'spread': '6.8', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'The scale range is from 0-32 and includes 8 items. The scale is used to measure signs of nicotine withdrawal where higher scores indicate higher severity.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'STANDARD_DEVIATION'}], 'populationDescription': 'Baseline values for outcomes reflect levels after participants were on the usual nicotine content cigarettes for 2 weeks and before they received the intervention.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2019-01-11', 'size': 429392, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2019-01-11T13:14', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 245}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-06', 'completionDateStruct': {'date': '2018-03-23', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-06-19', 'studyFirstSubmitDate': '2013-08-21', 'resultsFirstSubmitDate': '2019-01-11', 'studyFirstSubmitQcDate': '2013-08-21', 'lastUpdatePostDateStruct': {'date': '2019-06-28', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2019-01-11', 'studyFirstPostDateStruct': {'date': '2013-08-27', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2019-02-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-01-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Intention to Quit Smoking', 'timeFrame': 'At end of 18-week randomized trial phase', 'description': 'Smokers assigned to the reduced nicotine content cigarette group may have lower perceived dependence and be more likely to report intention to quit smoking'}, {'measure': 'Abstinence From Smoking', 'timeFrame': 'Follow-up appointment 30 weeks after randomization (12 weeks after last visit of randomized trial phase).', 'description': 'Smokers assigned to reduced nicotine content cigarettes will be more likely to successfully abstain from smoking at the end of the trial, based on all randomized participants, defined as no cigarette use in past 7 days, verified by exhaled carbon monoxide \\<10ppm.'}], 'primaryOutcomes': [{'measure': 'Plasma Cotinine Concentration', 'timeFrame': 'Measured at the end of the last 3 weeks of randomization trial phase', 'description': 'Plasma cotinine is a measure of daily nicotine exposure. Samples were measured in ng/mL.'}], 'secondaryOutcomes': [{'measure': 'Quick Inventory of Depressive Symptomatology', 'timeFrame': 'Measured at the end of the last 3 weeks of randomization trial phase', 'description': 'A 16-item scale on depression symptoms. The scale range is 0-27 where 0 = Least Severe and 27 = Most Severe.'}, {'measure': 'Perceived Stress Scale', 'timeFrame': 'Measured at the end of the last 3 weeks of randomization trial phase', 'description': '10-item questionnaire measuring the degree to which life situations are appraised stressful. Scale range is 0-40. Higher scores indicate more stress.'}, {'measure': 'Minnesota Nicotine Withdrawal Scale', 'timeFrame': 'Measured at the end of the last 3 weeks of randomization trial phase', 'description': 'This 8-item scale measures nicotine withdrawal symptoms and the scale range is from 0-32. Higher scores indicate higher severity.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Smoking', 'Nicotine'], 'conditions': ['Tobacco Dependence']}, 'referencesModule': {'references': [{'pmid': '28103841', 'type': 'BACKGROUND', 'citation': 'Allen SI, Foulds J, Pachas GN, Veldheer S, Cather C, Azzouz N, Hrabovsky S, Hameed A, Yingst J, Hammett E, Modesto J, Krebs NM, Zhu J, Liao J, Muscat JE, Richie J, Evins AE. A two-site, two-arm, 34-week, double-blind, parallel-group, randomized controlled trial of reduced nicotine cigarettes in smokers with mood and/or anxiety disorders: trial design and protocol. BMC Public Health. 2017 Jan 19;17(1):100. doi: 10.1186/s12889-016-3946-4.'}, {'pmid': '36322562', 'type': 'DERIVED', 'citation': 'Foulds J, Veldheer S, Pachas G, Hrabovsky S, Hameed A, Allen SI, Cather C, Azzouz N, Yingst J, Hammett E, Modesto J, Krebs NM, Lester C, Trushin N, Reinhart L, Wasserman E, Zhu J, Liao J, Muscat JE, Richie JP Jr, Evins AE. The effects of reduced nicotine content cigarettes on biomarkers of nicotine and toxicant exposure, smoking behavior and psychiatric symptoms in smokers with mood or anxiety disorders: A double-blind randomized trial. PLoS One. 2022 Nov 2;17(11):e0275522. doi: 10.1371/journal.pone.0275522. eCollection 2022.'}]}, 'descriptionModule': {'briefSummary': 'The overall aim of this project is to evaluate the effect of progressive nicotine reduction in cigarettes on smoking behavior, toxin exposure and psychiatric symptoms in smokers with comorbid mood and/or anxiety disorders.\n\nSmokers with mood and/or anxiety disorder will smoke research cigarettes that will contain either a) nicotine content similar to their preferred usual brand of cigarettes, or b) nicotine content per cigarette that is progressively reduced from approximately 11.6 mg to 0.2 mg per cigarette over 18 weeks.\n\nIt is our hypothesis that nicotine intake will decline as a function of cigarette nicotine content in the Reduced Nicotine Content group without significant increases in tobacco smoke exposure, severity of nicotine withdrawal symptoms, mood and anxiety symptomatology or protocol non-adherence over time in the Reduced Nicotine Content group as compared with the control group.', 'detailedDescription': 'The overall aim of this project is to evaluate the effect of progressive nicotine reduction in cigarettes on smoking behavior, toxicant exposure and psychiatric symptoms in smokers with comorbid mood and/or anxiety disorders.\n\nTo do so, we will randomly assign 200 adult smokers with a unipolar mood and/or anxiety disorder within the past year to smoke research cigarettes that will contain either a) Usual Nicotine Content (UNC): nicotine content similar to their preferred usual brand of cigarettes, or b) Reduced Nicotine Content (RNC): nicotine content per cigarette is progressively reduced from approximately 11.6 mg to 0.2 mg per cigarette over 18 weeks. All subjects will participate in baseline periods prior to double-blind randomization to assess normal smoking behavior and then to establish ability to tolerate research cigarettes prior to randomization.\n\nA total of 280 participants will be enrolled in the study at two sites with the aim of randomizing 200 who complete the baseline phase. 100 participants will be enrolled in the randomized phase at Penn State Hershey and 100 at the Massachusetts General Hospital site. Participants will be started on the study protocol during Baseline I and Baseline II but will be removed from the study if they are not able to comply with the protocol. We expect that approximately 40 participants at each site drop out from the study prior to randomization (due to inability to comply with study protocol).\n\nIt is our hypothesis that nicotine intake, as measured by plasma cotinine concentration, will decline as a function of cigarette nicotine content in the RNC group. Further, it is our hypothesis that by gradually reducing the nicotine content of the cigarettes in a step-wise fashion, there will not be significant increases in biomarkers of tobacco smoke exposure, severity of nicotine withdrawal symptoms, mood and anxiety symptomatology or protocol non-adherence over time in the experimental group (RNC) as compared with the UNC control group.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Smoke \\>4 cigarettes/day for at least a year\n* No quit attempt in prior month\n* Not planning to quit smoking within next 6 months\n* Plan to live in local area for next 8 months\n* Meet diagnostic criteria for a current or lifetime Anxiety Disorder or Mood Disorder as determined by the Mini-international Neuropsychiatric Interview\n* Read and write in English\n* Women not pregnant or nursing and taking steps to avoid pregnancy\n* Able to understand and consent to study procedures\n\nExclusion Criteria:\n\n* Unstable or significant medical condition such as Chronic Obstructive Pulmonary Disease or kidney failure\n* Use of non-cigarette nicotine delivery product in the past week or smoking cessation medicine in prior month\n* Currently reducing or planning to reduce cigarette consumption in next month\n* Uncontrolled serious psychotic illness or substance abuse or inpatient treatment for these in the past 6 months\n* Current suicide risk on clinical assessment\n* Aged \\<18 or \\>65\n* History of difficulty providing blood samples (fainting, poor venous access)\n* Unwilling to remain on one flavor of cigarette (regular or menthol) for the duration of the trial'}, 'identificationModule': {'nctId': 'NCT01928758', 'briefTitle': 'Reduced Nicotine Cigarettes in Smokers With Mood and Anxiety Disorders', 'organization': {'class': 'OTHER', 'fullName': 'Milton S. Hershey Medical Center'}, 'officialTitle': 'Reduced Nicotine Cigarettes in Smokers With Mood and Anxiety Disorders', 'orgStudyIdInfo': {'id': 'STUDY911'}, 'secondaryIdInfos': [{'id': 'P50DA036107', 'link': 'https://reporter.nih.gov/quickSearch/P50DA036107', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Reduced Nicotine Content Cigarettes', 'description': 'The experimental group will smoke cigarettes with gradually Reduced Nicotine Content (11.6, 7.4, 3.3, 1.4, 0.7 and 0.2 mg per cigarette) cigarettes, with each nicotine level smoked for 3 weeks, except the lowest level which continues for 6 weeks', 'interventionNames': ['Drug: Reduced Nicotine Content Cigarettes']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Usual Nicotine Content Cigarettes', 'description': 'Research cigarettes with a usual nicotine content (around 11.6mg per cigarette)', 'interventionNames': ['Drug: Usual Nicotine Content Cigarettes']}], 'interventions': [{'name': 'Reduced Nicotine Content Cigarettes', 'type': 'DRUG', 'otherNames': ['Nicotine'], 'description': 'Research cigarettes will have gradually reduced nicotine content', 'armGroupLabels': ['Reduced Nicotine Content Cigarettes']}, {'name': 'Usual Nicotine Content Cigarettes', 'type': 'DRUG', 'otherNames': ['Nicotine'], 'description': 'Usual Nicotine Content Cigarettes', 'armGroupLabels': ['Usual Nicotine Content Cigarettes']}]}, 'contactsLocationsModule': {'locations': [{'zip': '02199', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Massachusetts General Hospital', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '17033', 'city': 'Hershey', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Penn State College of Medicine', 'geoPoint': {'lat': 40.28592, 'lon': -76.65025}}], 'overallOfficials': [{'name': 'Jonathan A Foulds, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Penn State College of Medicine'}, {'name': 'A. Eden Evins, MD, MPH', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Massachusetts General Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Milton S. Hershey Medical Center', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institute on Drug Abuse (NIDA)', 'class': 'NIH'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Jonathan Foulds', 'investigatorAffiliation': 'Milton S. Hershey Medical Center'}}}}