Ignite Creation Date:
2025-12-24 @ 9:28 PM
Ignite Modification Date:
2025-12-25 @ 7:14 PM
Study NCT ID:
NCT01480232
Status:
TERMINATED
Last Update Posted:
2017-04-06
First Post:
2011-11-23
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
A Safety and Cognitive Function Study of EVP-6124 Versus Placebo in Subjects With Nicotine Dependence
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D014029', 'term': 'Tobacco Use Disorder'}, {'id': 'D016540', 'term': 'Smoking Cessation'}], 'ancestors': [{'id': 'D019966', 'term': 'Substance-Related Disorders'}, {'id': 'D064419', 'term': 'Chemically-Induced Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D015438', 'term': 'Health Behavior'}, {'id': 'D001519', 'term': 'Behavior'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C573817', 'term': '7-chloro-N-quinuclidin-3-yl-benzo(b)thiophene-2-carboxamide'}, {'id': 'D015444', 'term': 'Exercise'}, {'id': 'D001521', 'term': 'Behavior Therapy'}], 'ancestors': [{'id': 'D009043', 'term': 'Motor Activity'}, {'id': 'D009068', 'term': 'Movement'}, {'id': 'D009142', 'term': 'Musculoskeletal Physiological Phenomena'}, {'id': 'D055687', 'term': 'Musculoskeletal and Neural Physiological Phenomena'}, {'id': 'D011613', 'term': 'Psychotherapy'}, {'id': 'D004191', 'term': 'Behavioral Disciplines and Activities'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'aeevins@mgh.harvard.edu', 'phone': '617-643-4679', 'title': 'A. Eden Evins, MD, MPH', 'organization': 'Massachusetts General Hospital-Center for Addiction Medicine'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'week 1 to week 12', 'eventGroups': [{'id': 'EG000', 'title': 'EVP-6124 + NicoDerm (Active)', 'description': 'One EVP-6124 capsule ingested orally daily for 12 weeks (84 days) and one NicoDerm patch (Active) daily for first 6 weeks (42 days)\n\nEVP-6124: One EVP-6124 capsule ingested orally daily for 12 weeks (84 days)\n\nNicoDerm Patch (Active): One NicoDerm patch once daily for first 6 weeks (42 days). Dosage will taper from 21 mg (Weeks 1-3) to 14 mg (Weeks 4-5) to 7 mg (Week 6).\n\nBrief Supportive and Behavioral Treatment: Brief, standard, manualized individual cognitive behavioral therapy intervention will be based on the Freedom from Smoking curriculum from the American Lung Association.', 'otherNumAtRisk': 40, 'otherNumAffected': 35, 'seriousNumAtRisk': 40, 'seriousNumAffected': 1}, {'id': 'EG001', 'title': 'EVP-6124 + NRT Patch (Placebo)', 'description': 'One EVP-6124 capsule ingested orally daily for 12 weeks (84 days) and one NRT patch (Placebo) daily for first 6 weeks (42 days)\n\nEVP-6124: One EVP-6124 capsule ingested orally daily for 12 weeks (84 days)\n\nNRT Patch (Placebo): One NRT patch (Placebo) daily for first 6 weeks (42 days).\n\nBrief Supportive and Behavioral Treatment: Brief, standard, manualized individual cognitive behavioral therapy intervention will be based on the Freedom from Smoking curriculum from the American Lung Association.', 'otherNumAtRisk': 41, 'otherNumAffected': 30, 'seriousNumAtRisk': 41, 'seriousNumAffected': 1}, {'id': 'EG002', 'title': 'Placebo + NicoDerm (Active)', 'description': 'One placebo capsule ingested orally daily for 12 weeks (84 days) and one NicoDerm patch (Active) daily for first 6 weeks (42 days)\n\nPlacebo Capsule: One placebo capsule ingested orally daily for 12 weeks (84 days)\n\nNicoDerm Patch (Active): One NicoDerm patch once daily for first 6 weeks (42 days). Dosage will taper from 21 mg (Weeks 1-3) to 14 mg (Weeks 4-5) to 7 mg (Week 6).\n\nBrief Supportive and Behavioral Treatment: Brief, standard, manualized individual cognitive behavioral therapy intervention will be based on the Freedom from Smoking curriculum from the American Lung Association.', 'otherNumAtRisk': 38, 'otherNumAffected': 34, 'seriousNumAtRisk': 38, 'seriousNumAffected': 1}, {'id': 'EG003', 'title': 'Placebo + NRT Patch (Placebo)', 'description': 'One placebo capsule ingested orally daily for 12 weeks (84 days) and one NRT patch (Placebo) daily for first 6 weeks (42 days)\n\nPlacebo Capsule: One placebo capsule ingested orally daily for 12 weeks (84 days)\n\nNRT Patch (Placebo): One NRT patch (Placebo) daily for first 6 weeks (42 days).\n\nBrief Supportive and Behavioral Treatment: Brief, standard, manualized individual cognitive behavioral therapy intervention will be based on the Freedom from Smoking curriculum from the American Lung Association.', 'otherNumAtRisk': 41, 'otherNumAffected': 34, 'seriousNumAtRisk': 41, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numEvents': 11, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 41, 'numEvents': 8, 'numAffected': 8}, {'groupId': 'EG002', 'numAtRisk': 38, 'numEvents': 8, 'numAffected': 8}, {'groupId': 'EG003', 'numAtRisk': 41, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Upper respiratory infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numEvents': 10, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 41, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 38, 'numEvents': 7, 'numAffected': 7}, {'groupId': 'EG003', 'numAtRisk': 41, 'numAffected': 7}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Elevated Creatine phosphokinase (CPK)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 41, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 38, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 41, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Depressive symptoms', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 41, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 38, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 41, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numEvents': 10, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 41, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 38, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 41, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Cold/flu', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numEvents': 7, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 41, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 38, 'numEvents': 7, 'numAffected': 7}, {'groupId': 'EG003', 'numAtRisk': 41, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Skin Irritation at Patch Site', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numEvents': 12, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 41, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 38, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 41, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 41, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 38, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 41, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Insomnia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 41, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 38, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG003', 'numAtRisk': 41, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Stomach pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 41, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 38, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 41, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 41, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 38, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 41, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Anxiety', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 41, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 38, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 41, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'weight gain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 41, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 38, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 41, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Irritability', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 41, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 38, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 41, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Increase appetite', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 41, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 38, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 41, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Muscle spasm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numEvents': 7, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 41, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 38, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 41, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Allergies', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 41, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 38, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 41, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Abnormal sleeping pattern', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 41, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 38, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG003', 'numAtRisk': 41, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'seriousEvents': [{'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 41, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 38, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 41, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Diverticulitis Flare', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 41, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 38, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 41, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Effects of EVP-6124 on 7-day Point-prevalence Smoking Abstinence', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}, {'value': '41', 'groupId': 'OG001'}, {'value': '38', 'groupId': 'OG002'}, {'value': '41', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'EVP-6124 + NicoDerm CQ (Active)', 'description': 'One EVP-6124 capsule ingested orally daily for 12 weeks (84 days) and one NicoDerm CQ patch (Active) daily for first 6 weeks (42 days)\n\nEVP-6124: One EVP-6124 capsule ingested orally daily for 12 weeks (84 days)\n\nNicoDerm CQ Patch (Active): One NicoDerm CQ patch once daily for first 6 weeks (42 days). Dosage will taper from 21 mg (Weeks 1-3) to 14 mg (Weeks 4-5) to 7 mg (Week 6).\n\nBrief Supportive and Behavioral Treatment: Brief, standard, manualized individual cognitive behavioral therapy intervention will be based on the Freedom from Smoking curriculum from the American Lung Association.'}, {'id': 'OG001', 'title': 'EVP-6124 + NRT Patch (Placebo)', 'description': 'One EVP-6124 capsule ingested orally daily for 12 weeks (84 days) and one NRT patch (Placebo) daily for first 6 weeks (42 days)\n\nEVP-6124: One EVP-6124 capsule ingested orally daily for 12 weeks (84 days)\n\nNRT Patch (Placebo): One NRT patch (Placebo) daily for first 6 weeks (42 days).\n\nBrief Supportive and Behavioral Treatment: Brief, standard, manualized individual cognitive behavioral therapy intervention will be based on the Freedom from Smoking curriculum from the American Lung Association.'}, {'id': 'OG002', 'title': 'Placebo + NicoDerm CQ (Active)', 'description': 'One placebo capsule ingested orally daily for 12 weeks (84 days) and one NicoDerm CQ patch (Active) daily for first 6 weeks (42 days)\n\nPlacebo Capsule: One placebo capsule ingested orally daily for 12 weeks (84 days)\n\nNicoDerm CQ Patch (Active): One NicoDerm CQ patch once daily for first 6 weeks (42 days). Dosage will taper from 21 mg (Weeks 1-3) to 14 mg (Weeks 4-5) to 7 mg (Week 6).\n\nBrief Supportive and Behavioral Treatment: Brief, standard, manualized individual cognitive behavioral therapy intervention will be based on the Freedom from Smoking curriculum from the American Lung Association.'}, {'id': 'OG003', 'title': 'Placebo + NRT Patch (Placebo)', 'description': 'One placebo capsule ingested orally daily for 12 weeks (84 days) and one NRT patch (Placebo) daily for first 6 weeks (42 days)\n\nPlacebo Capsule: One placebo capsule ingested orally daily for 12 weeks (84 days)\n\nNRT Patch (Placebo): One NRT patch (Placebo) daily for first 6 weeks (42 days).\n\nBrief Supportive and Behavioral Treatment: Brief, standard, manualized individual cognitive behavioral therapy intervention will be based on the Freedom from Smoking curriculum from the American Lung Association.'}], 'classes': [{'title': 'Seven-Day Point Prevalence Abstinence Rate week 1', 'categories': [{'measurements': [{'value': '25.0', 'groupId': 'OG000'}, {'value': '12.2', 'groupId': 'OG001'}, {'value': '28.9', 'groupId': 'OG002'}, {'value': '17.1', 'groupId': 'OG003'}]}]}, {'title': 'Seven-Day Point Prevalence Abstinence Rate week 2', 'categories': [{'measurements': [{'value': '47.5', 'groupId': 'OG000'}, {'value': '19.5', 'groupId': 'OG001'}, {'value': '42.1', 'groupId': 'OG002'}, {'value': '24.4', 'groupId': 'OG003'}]}]}, {'title': 'Seven-Day Point Prevalence Abstinence Rate week 4', 'categories': [{'measurements': [{'value': '40.0', 'groupId': 'OG000'}, {'value': '17.1', 'groupId': 'OG001'}, {'value': '44.7', 'groupId': 'OG002'}, {'value': '19.5', 'groupId': 'OG003'}]}]}, {'title': 'Seven-Day Point Prevalence Abstinence Rate week 6', 'categories': [{'measurements': [{'value': '52.5', 'groupId': 'OG000'}, {'value': '14.6', 'groupId': 'OG001'}, {'value': '34.2', 'groupId': 'OG002'}, {'value': '22.0', 'groupId': 'OG003'}]}]}, {'title': 'Seven-Day Point Prevalence Abstinence Rate week 8', 'categories': [{'measurements': [{'value': '37.5', 'groupId': 'OG000'}, {'value': '14.6', 'groupId': 'OG001'}, {'value': '28.9', 'groupId': 'OG002'}, {'value': '24.4', 'groupId': 'OG003'}]}]}, {'title': 'Seven-Day Point Prevalence Abstinence Rate week 10', 'categories': [{'measurements': [{'value': '37.5', 'groupId': 'OG000'}, {'value': '12.2', 'groupId': 'OG001'}, {'value': '23.7', 'groupId': 'OG002'}, {'value': '24.4', 'groupId': 'OG003'}]}]}, {'title': 'Seven-Day Point Prevalence Abstinence Rate week 12', 'categories': [{'measurements': [{'value': '25.0', 'groupId': 'OG000'}, {'value': '12.2', 'groupId': 'OG001'}, {'value': '18.4', 'groupId': 'OG002'}, {'value': '19.5', 'groupId': 'OG003'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Week 1, 2, 4, 6, 8, 10, 12', 'description': 'Smoking abstinence is defined as a self-report of smoking no cigarettes for the past 7 days by time-line follow-back, confirmed by expired carbon monoxide (CO) \\<10 ppm and/or urine cotinine \\<50 ng/mL.', 'unitOfMeasure': '% participants with 7-Day Point Prevalen', 'reportingStatus': 'POSTED', 'populationDescription': 'The primary smoking cessation variable is biochemically verified self-report of 7-day point prevalence abstinence at 12 weeks (end of treatment).'}, {'type': 'PRIMARY', 'title': 'Difference in Expired Carbon Monoxide (CO) Concentration From Baseline to End Point', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}, {'value': '41', 'groupId': 'OG001'}, {'value': '38', 'groupId': 'OG002'}, {'value': '41', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'EVP-6124 + NicoDerm CQ (Active)', 'description': 'One EVP-6124 capsule ingested orally daily for 12 weeks (84 days) and one NicoDerm CQ patch (Active) daily for first 6 weeks (42 days)\n\nEVP-6124: One EVP-6124 capsule ingested orally daily for 12 weeks (84 days)\n\nNicoDerm CQ Patch (Active): One NicoDerm CQ patch once daily for first 6 weeks (42 days). Dosage will taper from 21 mg (Weeks 1-3) to 14 mg (Weeks 4-5) to 7 mg (Week 6).\n\nBrief Supportive and Behavioral Treatment: Brief, standard, manualized individual cognitive behavioral therapy intervention will be based on the Freedom from Smoking curriculum from the American Lung Association.'}, {'id': 'OG001', 'title': 'EVP-6124 + NRT Patch (Placebo)', 'description': 'One EVP-6124 capsule ingested orally daily for 12 weeks (84 days) and one NRT patch (Placebo) daily for first 6 weeks (42 days)\n\nEVP-6124: One EVP-6124 capsule ingested orally daily for 12 weeks (84 days)\n\nNRT Patch (Placebo): One NRT patch (Placebo) daily for first 6 weeks (42 days).\n\nBrief Supportive and Behavioral Treatment: Brief, standard, manualized individual cognitive behavioral therapy intervention will be based on the Freedom from Smoking curriculum from the American Lung Association.'}, {'id': 'OG002', 'title': 'Placebo + NicoDerm CQ (Active)', 'description': 'One placebo capsule ingested orally daily for 12 weeks (84 days) and one NicoDerm CQ patch (Active) daily for first 6 weeks (42 days)\n\nPlacebo Capsule: One placebo capsule ingested orally daily for 12 weeks (84 days)\n\nNicoDerm CQ Patch (Active): One NicoDerm CQ patch once daily for first 6 weeks (42 days). Dosage will taper from 21 mg (Weeks 1-3) to 14 mg (Weeks 4-5) to 7 mg (Week 6).\n\nBrief Supportive and Behavioral Treatment: Brief, standard, manualized individual cognitive behavioral therapy intervention will be based on the Freedom from Smoking curriculum from the American Lung Association.'}, {'id': 'OG003', 'title': 'Placebo + NRT Patch (Placebo)', 'description': 'One placebo capsule ingested orally daily for 12 weeks (84 days) and one NRT patch (Placebo) daily for first 6 weeks (42 days)\n\nPlacebo Capsule: One placebo capsule ingested orally daily for 12 weeks (84 days)\n\nNRT Patch (Placebo): One NRT patch (Placebo) daily for first 6 weeks (42 days).\n\nBrief Supportive and Behavioral Treatment: Brief, standard, manualized individual cognitive behavioral therapy intervention will be based on the Freedom from Smoking curriculum from the American Lung Association.'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '20.2', 'spread': '11', 'groupId': 'OG000'}, {'value': '17.2', 'spread': '9.8', 'groupId': 'OG001'}, {'value': '20.5', 'spread': '13.7', 'groupId': 'OG002'}, {'value': '19.3', 'spread': '9.4', 'groupId': 'OG003'}]}]}, {'title': 'Week 1', 'categories': [{'measurements': [{'value': '8.6', 'spread': '11', 'groupId': 'OG000'}, {'value': '9.2', 'spread': '10.1', 'groupId': 'OG001'}, {'value': '5.2', 'spread': '6', 'groupId': 'OG002'}, {'value': '8.1', 'spread': '8.6', 'groupId': 'OG003'}]}]}, {'title': 'Week 2', 'categories': [{'measurements': [{'value': '7.7', 'spread': '11.5', 'groupId': 'OG000'}, {'value': '10.1', 'spread': '10.2', 'groupId': 'OG001'}, {'value': '4.9', 'spread': '5.4', 'groupId': 'OG002'}, {'value': '8.5', 'spread': '8.5', 'groupId': 'OG003'}]}]}, {'title': 'Week 4', 'categories': [{'measurements': [{'value': '6.1', 'spread': '7.7', 'groupId': 'OG000'}, {'value': '9.8', 'spread': '11.5', 'groupId': 'OG001'}, {'value': '6.3', 'spread': '7.9', 'groupId': 'OG002'}, {'value': '9.6', 'spread': '10.5', 'groupId': 'OG003'}]}]}, {'title': 'Week 6', 'categories': [{'measurements': [{'value': '7.5', 'spread': '11.4', 'groupId': 'OG000'}, {'value': '12.7', 'spread': '16.3', 'groupId': 'OG001'}, {'value': '5.3', 'spread': '5.7', 'groupId': 'OG002'}, {'value': '7.8', 'spread': '6.4', 'groupId': 'OG003'}]}]}, {'title': 'Week 8', 'categories': [{'measurements': [{'value': '7.2', 'spread': '10.5', 'groupId': 'OG000'}, {'value': '12.6', 'spread': '16.8', 'groupId': 'OG001'}, {'value': '7.5', 'spread': '6.4', 'groupId': 'OG002'}, {'value': '7.6', 'spread': '6.8', 'groupId': 'OG003'}]}]}, {'title': 'Week 10', 'categories': [{'measurements': [{'value': '7.2', 'spread': '10.9', 'groupId': 'OG000'}, {'value': '11.2', 'spread': '11.9', 'groupId': 'OG001'}, {'value': '8.2', 'spread': '7.4', 'groupId': 'OG002'}, {'value': '5.3', 'spread': '5', 'groupId': 'OG003'}]}]}, {'title': 'Week 12', 'categories': [{'measurements': [{'value': '8.8', 'spread': '8.7', 'groupId': 'OG000'}, {'value': '11.4', 'spread': '13.6', 'groupId': 'OG001'}, {'value': '9', 'spread': '8.1', 'groupId': 'OG002'}, {'value': '8.3', 'spread': '9.3', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Weeks 1, 2, 4, 6, 8, 10, 12', 'description': 'CO concentration was measured at every visit.', 'unitOfMeasure': 'part per million', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Effects of EVP-6124 on Cognitive Performance as Measured by the Continuous Performance Test Hit Reaction Time', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}, {'value': '41', 'groupId': 'OG001'}, {'value': '38', 'groupId': 'OG002'}, {'value': '41', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'EVP-6124 + NicoDerm CQ (Active)', 'description': 'One EVP-6124 capsule ingested orally daily for 12 weeks (84 days) and one NicoDerm CQ patch (Active) daily for first 6 weeks (42 days)\n\nEVP-6124: One EVP-6124 capsule ingested orally daily for 12 weeks (84 days)\n\nNicoDerm CQ Patch (Active): One NicoDerm CQ patch once daily for first 6 weeks (42 days). Dosage will taper from 21 mg (Weeks 1-3) to 14 mg (Weeks 4-5) to 7 mg (Week 6).\n\nBrief Supportive and Behavioral Treatment: Brief, standard, manualized individual cognitive behavioral therapy intervention will be based on the Freedom from Smoking curriculum from the American Lung Association.'}, {'id': 'OG001', 'title': 'EVP-6124 + NRT Patch (Placebo)', 'description': 'One EVP-6124 capsule ingested orally daily for 12 weeks (84 days) and one NRT patch (Placebo) daily for first 6 weeks (42 days)\n\nEVP-6124: One EVP-6124 capsule ingested orally daily for 12 weeks (84 days)\n\nNRT Patch (Placebo): One NRT patch (Placebo) daily for first 6 weeks (42 days).\n\nBrief Supportive and Behavioral Treatment: Brief, standard, manualized individual cognitive behavioral therapy intervention will be based on the Freedom from Smoking curriculum from the American Lung Association.'}, {'id': 'OG002', 'title': 'Placebo + NicoDerm CQ (Active)', 'description': 'One placebo capsule ingested orally daily for 12 weeks (84 days) and one NicoDerm CQ patch (Active) daily for first 6 weeks (42 days)\n\nPlacebo Capsule: One placebo capsule ingested orally daily for 12 weeks (84 days)\n\nNicoDerm CQ Patch (Active): One NicoDerm CQ patch once daily for first 6 weeks (42 days). Dosage will taper from 21 mg (Weeks 1-3) to 14 mg (Weeks 4-5) to 7 mg (Week 6).\n\nBrief Supportive and Behavioral Treatment: Brief, standard, manualized individual cognitive behavioral therapy intervention will be based on the Freedom from Smoking curriculum from the American Lung Association.'}, {'id': 'OG003', 'title': 'Placebo + NRT Patch (Placebo)', 'description': 'One placebo capsule ingested orally daily for 12 weeks (84 days) and one NRT patch (Placebo) daily for first 6 weeks (42 days)\n\nPlacebo Capsule: One placebo capsule ingested orally daily for 12 weeks (84 days)\n\nNRT Patch (Placebo): One NRT patch (Placebo) daily for first 6 weeks (42 days).\n\nBrief Supportive and Behavioral Treatment: Brief, standard, manualized individual cognitive behavioral therapy intervention will be based on the Freedom from Smoking curriculum from the American Lung Association.'}], 'classes': [{'title': 'Baseline Hit RT', 'categories': [{'measurements': [{'value': '436.26', 'spread': '78.15', 'groupId': 'OG000'}, {'value': '434.72', 'spread': '65.40', 'groupId': 'OG001'}, {'value': '427.76', 'spread': '66.87', 'groupId': 'OG002'}, {'value': '423.94', 'spread': '72.58', 'groupId': 'OG003'}]}]}, {'title': 'Week 1 Hit RT', 'categories': [{'measurements': [{'value': '424.77', 'spread': '76.85', 'groupId': 'OG000'}, {'value': '429.99', 'spread': '59.94', 'groupId': 'OG001'}, {'value': '418.74', 'spread': '60.32', 'groupId': 'OG002'}, {'value': '407.97', 'spread': '68.01', 'groupId': 'OG003'}]}]}, {'title': 'Week 12 Hit RT', 'categories': [{'measurements': [{'value': '441.73', 'spread': '71.59', 'groupId': 'OG000'}, {'value': '421.66', 'spread': '67.67', 'groupId': 'OG001'}, {'value': '432.56', 'spread': '73.91', 'groupId': 'OG002'}, {'value': '396.78', 'spread': '53.44', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, week 1, week 12', 'description': "The Continuous Performance Test (CPT) is a measure of both vigilance/attentional control and response inhibition. During the task, subjects are required to press a button whenever a letter appears on the screen unless that letter is an 'X'. Measures of attentional control will serve as primary measure from this test. Baseline attentional impairment is associated with reduced odds of abstinence, abstinence differentially worsens performance on this measure in those with baseline attentional impairment, and NRT improves performance on a similar measure.", 'unitOfMeasure': 'mili seconds', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Safety and Tolerability of EVP-6124 Alone or Combined With NRT', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}, {'value': '41', 'groupId': 'OG001'}, {'value': '38', 'groupId': 'OG002'}, {'value': '41', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'EVP-6124 + NicoDerm CQ (Active)', 'description': 'One EVP-6124 capsule ingested orally daily for 12 weeks (84 days) and one NicoDerm CQ patch (Active) daily for first 6 weeks (42 days)\n\nEVP-6124: One EVP-6124 capsule ingested orally daily for 12 weeks (84 days)\n\nNicoDerm CQ Patch (Active): One NicoDerm CQ patch once daily for first 6 weeks (42 days). Dosage will taper from 21 mg (Weeks 1-3) to 14 mg (Weeks 4-5) to 7 mg (Week 6).\n\nBrief Supportive and Behavioral Treatment: Brief, standard, manualized individual cognitive behavioral therapy intervention will be based on the Freedom from Smoking curriculum from the American Lung Association.'}, {'id': 'OG001', 'title': 'EVP-6124 + NRT Patch (Placebo)', 'description': 'One EVP-6124 capsule ingested orally daily for 12 weeks (84 days) and one NRT patch (Placebo) daily for first 6 weeks (42 days)\n\nEVP-6124: One EVP-6124 capsule ingested orally daily for 12 weeks (84 days)\n\nNRT Patch (Placebo): One NRT patch (Placebo) daily for first 6 weeks (42 days).\n\nBrief Supportive and Behavioral Treatment: Brief, standard, manualized individual cognitive behavioral therapy intervention will be based on the Freedom from Smoking curriculum from the American Lung Association.'}, {'id': 'OG002', 'title': 'Placebo + NicoDerm CQ (Active)', 'description': 'One placebo capsule ingested orally daily for 12 weeks (84 days) and one NicoDerm CQ patch (Active) daily for first 6 weeks (42 days)\n\nPlacebo Capsule: One placebo capsule ingested orally daily for 12 weeks (84 days)\n\nNicoDerm CQ Patch (Active): One NicoDerm CQ patch once daily for first 6 weeks (42 days). Dosage will taper from 21 mg (Weeks 1-3) to 14 mg (Weeks 4-5) to 7 mg (Week 6).\n\nBrief Supportive and Behavioral Treatment: Brief, standard, manualized individual cognitive behavioral therapy intervention will be based on the Freedom from Smoking curriculum from the American Lung Association.'}, {'id': 'OG003', 'title': 'Placebo + NRT Patch (Placebo)', 'description': 'One placebo capsule ingested orally daily for 12 weeks (84 days) and one NRT patch (Placebo) daily for first 6 weeks (42 days)\n\nPlacebo Capsule: One placebo capsule ingested orally daily for 12 weeks (84 days)\n\nNRT Patch (Placebo): One NRT patch (Placebo) daily for first 6 weeks (42 days).\n\nBrief Supportive and Behavioral Treatment: Brief, standard, manualized individual cognitive behavioral therapy intervention will be based on the Freedom from Smoking curriculum from the American Lung Association.'}], 'classes': [{'categories': [{'measurements': [{'value': '35', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}, {'value': '34', 'groupId': 'OG002'}, {'value': '34', 'groupId': 'OG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Weeks 1-12', 'description': 'All AEs (adverse experiences) spontaneously reported by subjects and/or observed by investigator and evaluation of physical examinations, prior and concomitant medications, clinical laboratory tests, ECGs, and vital signs measurements. Data was collected at every visit and was analyzed as aggregate at the end of week 12', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Effects of EVP-6124 on Working Memory as Measured by the N-Back Task Reaction Time', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}, {'value': '41', 'groupId': 'OG001'}, {'value': '38', 'groupId': 'OG002'}, {'value': '41', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'EVP-6124 + NicoDerm CQ (Active)', 'description': 'One EVP-6124 capsule ingested orally daily for 12 weeks (84 days) and one NicoDerm CQ patch (Active) daily for first 6 weeks (42 days)\n\nEVP-6124: One EVP-6124 capsule ingested orally daily for 12 weeks (84 days)\n\nNicoDerm CQ Patch (Active): One NicoDerm CQ patch once daily for first 6 weeks (42 days). Dosage will taper from 21 mg (Weeks 1-3) to 14 mg (Weeks 4-5) to 7 mg (Week 6).\n\nBrief Supportive and Behavioral Treatment: Brief, standard, manualized individual cognitive behavioral therapy intervention will be based on the Freedom from Smoking curriculum from the American Lung Association.'}, {'id': 'OG001', 'title': 'EVP-6124 + NRT Patch (Placebo)', 'description': 'One EVP-6124 capsule ingested orally daily for 12 weeks (84 days) and one NRT patch (Placebo) daily for first 6 weeks (42 days)\n\nEVP-6124: One EVP-6124 capsule ingested orally daily for 12 weeks (84 days)\n\nNRT Patch (Placebo): One NRT patch (Placebo) daily for first 6 weeks (42 days).\n\nBrief Supportive and Behavioral Treatment: Brief, standard, manualized individual cognitive behavioral therapy intervention will be based on the Freedom from Smoking curriculum from the American Lung Association.'}, {'id': 'OG002', 'title': 'Placebo + NicoDerm CQ (Active)', 'description': 'One placebo capsule ingested orally daily for 12 weeks (84 days) and one NicoDerm CQ patch (Active) daily for first 6 weeks (42 days)\n\nPlacebo Capsule: One placebo capsule ingested orally daily for 12 weeks (84 days)\n\nNicoDerm CQ Patch (Active): One NicoDerm CQ patch once daily for first 6 weeks (42 days). Dosage will taper from 21 mg (Weeks 1-3) to 14 mg (Weeks 4-5) to 7 mg (Week 6).\n\nBrief Supportive and Behavioral Treatment: Brief, standard, manualized individual cognitive behavioral therapy intervention will be based on the Freedom from Smoking curriculum from the American Lung Association.'}, {'id': 'OG003', 'title': 'Placebo + NRT Patch (Placebo)', 'description': 'One placebo capsule ingested orally daily for 12 weeks (84 days) and one NRT patch (Placebo) daily for first 6 weeks (42 days)\n\nPlacebo Capsule: One placebo capsule ingested orally daily for 12 weeks (84 days)\n\nNRT Patch (Placebo): One NRT patch (Placebo) daily for first 6 weeks (42 days).\n\nBrief Supportive and Behavioral Treatment: Brief, standard, manualized individual cognitive behavioral therapy intervention will be based on the Freedom from Smoking curriculum from the American Lung Association.'}], 'classes': [{'title': 'Baseline 2-Back RT', 'categories': [{'measurements': [{'value': '634.04', 'spread': '166.51', 'groupId': 'OG000'}, {'value': '645.01', 'spread': '180.83', 'groupId': 'OG001'}, {'value': '632.80', 'spread': '176.78', 'groupId': 'OG002'}, {'value': '616.33', 'spread': '186.83', 'groupId': 'OG003'}]}]}, {'title': 'Baseline 3-Back RT', 'categories': [{'measurements': [{'value': '667.75', 'spread': '202.35', 'groupId': 'OG000'}, {'value': '642.89', 'spread': '182.20', 'groupId': 'OG001'}, {'value': '620.55', 'spread': '210.04', 'groupId': 'OG002'}, {'value': '600.78', 'spread': '179.64', 'groupId': 'OG003'}]}]}, {'title': 'Week 1 2-Back RT', 'categories': [{'measurements': [{'value': '578.58', 'spread': '101.86', 'groupId': 'OG000'}, {'value': '619.42', 'spread': '174.86', 'groupId': 'OG001'}, {'value': '565.84', 'spread': '148.24', 'groupId': 'OG002'}, {'value': '553.90', 'spread': '135.00', 'groupId': 'OG003'}]}]}, {'title': 'Week 1 3-Back RT', 'categories': [{'measurements': [{'value': '635.08', 'spread': '164.16', 'groupId': 'OG000'}, {'value': '627.85', 'spread': '180.06', 'groupId': 'OG001'}, {'value': '608.94', 'spread': '152.38', 'groupId': 'OG002'}, {'value': '586.15', 'spread': '173.28', 'groupId': 'OG003'}]}]}, {'title': 'Week 12 2-Back RT', 'categories': [{'measurements': [{'value': '608.03', 'spread': '145.92', 'groupId': 'OG000'}, {'value': '620.28', 'spread': '175.61', 'groupId': 'OG001'}, {'value': '598.47', 'spread': '156.28', 'groupId': 'OG002'}, {'value': '565.41', 'spread': '149.08', 'groupId': 'OG003'}]}]}, {'title': 'Week 12 3-Back RT', 'categories': [{'measurements': [{'value': '639.51', 'spread': '175.91', 'groupId': 'OG000'}, {'value': '613.75', 'spread': '176.40', 'groupId': 'OG001'}, {'value': '611.85', 'spread': '185.75', 'groupId': 'OG002'}, {'value': '585.15', 'spread': '177.86', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, week 1, week 12', 'description': 'This task is a standard measure that can assess working memory performance under varying levels of task demand. Subjects are presented with a stream of stimuli, and the task is to decide for each stimulus whether it matches the one presented N items before. The processing load can be varied systematically by manipulating the value of N, which is expressed with changes in accuracy and reaction time. The number of errors as well as reaction times increase monotonically with increasing levels of N. The n-back task is sensitive to nicotine administration and abstinence effects. Here we present reaction time (RT)', 'unitOfMeasure': 'mili seconds', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'EVP-6124 + NicoDerm (Active)', 'description': 'One EVP-6124 capsule ingested orally daily for 12 weeks (84 days) and one NicoDerm patch (Active) daily for first 6 weeks (42 days)\n\nEVP-6124: One EVP-6124 capsule ingested orally daily for 12 weeks (84 days)\n\nNicoDerm Patch (Active): One NicoDerm patch once daily for first 6 weeks (42 days). Dosage will taper from 21 mg (Weeks 1-3) to 14 mg (Weeks 4-5) to 7 mg (Week 6).\n\nBrief Supportive and Behavioral Treatment: Brief, standard, manualized individual cognitive behavioral therapy intervention will be based on the Freedom from Smoking curriculum from the American Lung Association.'}, {'id': 'FG001', 'title': 'EVP-6124 + NRT Patch (Placebo)', 'description': 'One EVP-6124 capsule ingested orally daily for 12 weeks (84 days) and one NRT patch (Placebo) daily for first 6 weeks (42 days)\n\nEVP-6124: One EVP-6124 capsule ingested orally daily for 12 weeks (84 days)\n\nNRT (nicotine replacement therapy) Patch (Placebo): One NRT patch (Placebo) daily for first 6 weeks (42 days).\n\nBrief Supportive and Behavioral Treatment: Brief, standard, manualized individual cognitive behavioral therapy intervention will be based on the Freedom from Smoking curriculum from the American Lung Association.'}, {'id': 'FG002', 'title': 'Placebo + NicoDerm (Active)', 'description': 'One placebo capsule ingested orally daily for 12 weeks (84 days) and one NicoDerm patch (Active) daily for first 6 weeks (42 days)\n\nPlacebo Capsule: One placebo capsule ingested orally daily for 12 weeks (84 days)\n\nNicoDerm Patch (Active): One NicoDerm patch once daily for first 6 weeks (42 days). Dosage will taper from 21 mg (Weeks 1-3) to 14 mg (Weeks 4-5) to 7 mg (Week 6).\n\nBrief Supportive and Behavioral Treatment: Brief, standard, manualized individual cognitive behavioral therapy intervention will be based on the Freedom from Smoking curriculum from the American Lung Association.'}, {'id': 'FG003', 'title': 'Placebo + NRT Patch (Placebo)', 'description': 'One placebo capsule ingested orally daily for 12 weeks (84 days) and one NRT patch (Placebo) daily for first 6 weeks (42 days)\n\nPlacebo Capsule: One placebo capsule ingested orally daily for 12 weeks (84 days)\n\nNRT Patch (Placebo): One NRT patch (Placebo) daily for first 6 weeks (42 days).\n\nBrief Supportive and Behavioral Treatment: Brief, standard, manualized individual cognitive behavioral therapy intervention will be based on the Freedom from Smoking curriculum from the American Lung Association.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '40'}, {'groupId': 'FG001', 'numSubjects': '41'}, {'groupId': 'FG002', 'numSubjects': '38'}, {'groupId': 'FG003', 'numSubjects': '41'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '22'}, {'groupId': 'FG001', 'numSubjects': '19'}, {'groupId': 'FG002', 'numSubjects': '21'}, {'groupId': 'FG003', 'numSubjects': '22'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '18'}, {'groupId': 'FG001', 'numSubjects': '22'}, {'groupId': 'FG002', 'numSubjects': '17'}, {'groupId': 'FG003', 'numSubjects': '19'}]}]}], 'recruitmentDetails': 'Subjects were recruited using advertisements in the local media market.Those who made contact in response to advertisements spoke initially with a research coordinator who provided further information about the study, answered initial questions from the potential subject, and administered a 10-minute questionnaire assessing eligibility.', 'preAssignmentDetails': 'Prior to initiation of any study procedures, the informed consent process was conducted by a study physician who explained the study in detail making sure that the subject understood the potential risks/benefits as outlined in the consent form; 350 signed consent, 60 were found ineligible and 130 either withdrew consent or was discontinued'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'BG000'}, {'value': '41', 'groupId': 'BG001'}, {'value': '38', 'groupId': 'BG002'}, {'value': '41', 'groupId': 'BG003'}, {'value': '160', 'groupId': 'BG004'}]}], 'groups': [{'id': 'BG000', 'title': 'EVP-6124 + NicoDerm (Active)', 'description': 'One EVP-6124 capsule ingested orally daily for 12 weeks (84 days) and one NicoDerm patch (Active) daily for first 6 weeks (42 days)\n\nEVP-6124: One EVP-6124 capsule ingested orally daily for 12 weeks (84 days)\n\nNicoDerm Patch (Active): One NicoDerm patch once daily for first 6 weeks (42 days). Dosage will taper from 21 mg (Weeks 1-3) to 14 mg (Weeks 4-5) to 7 mg (Week 6).\n\nBrief Supportive and Behavioral Treatment: Brief, standard, manualized individual cognitive behavioral therapy intervention will be based on the Freedom from Smoking curriculum from the American Lung Association.'}, {'id': 'BG001', 'title': 'EVP-6124 + NRT Patch (Placebo)', 'description': 'One EVP-6124 capsule ingested orally daily for 12 weeks (84 days) and one NRT patch (Placebo) daily for first 6 weeks (42 days)\n\nEVP-6124: One EVP-6124 capsule ingested orally daily for 12 weeks (84 days)\n\nNRT Patch (Placebo): One NRT patch (Placebo) daily for first 6 weeks (42 days).\n\nBrief Supportive and Behavioral Treatment: Brief, standard, manualized individual cognitive behavioral therapy intervention will be based on the Freedom from Smoking curriculum from the American Lung Association.'}, {'id': 'BG002', 'title': 'Placebo + NicoDerm (Active)', 'description': 'One placebo capsule ingested orally daily for 12 weeks (84 days) and one NicoDerm patch (Active) daily for first 6 weeks (42 days)\n\nPlacebo Capsule: One placebo capsule ingested orally daily for 12 weeks (84 days)\n\nNicoDerm Patch (Active): One NicoDerm patch once daily for first 6 weeks (42 days). Dosage will taper from 21 mg (Weeks 1-3) to 14 mg (Weeks 4-5) to 7 mg (Week 6).\n\nBrief Supportive and Behavioral Treatment: Brief, standard, manualized individual cognitive behavioral therapy intervention will be based on the Freedom from Smoking curriculum from the American Lung Association.'}, {'id': 'BG003', 'title': 'Placebo + NRT Patch (Placebo)', 'description': 'One placebo capsule ingested orally daily for 12 weeks (84 days) and one NRT patch (Placebo) daily for first 6 weeks (42 days)\n\nPlacebo Capsule: One placebo capsule ingested orally daily for 12 weeks (84 days)\n\nNRT Patch (Placebo): One NRT patch (Placebo) daily for first 6 weeks (42 days).\n\nBrief Supportive and Behavioral Treatment: Brief, standard, manualized individual cognitive behavioral therapy intervention will be based on the Freedom from Smoking curriculum from the American Lung Association.'}, {'id': 'BG004', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '42.63', 'spread': '12.17', 'groupId': 'BG000'}, {'value': '44.70', 'spread': '13.06', 'groupId': 'BG001'}, {'value': '44.03', 'spread': '12.81', 'groupId': 'BG002'}, {'value': '45.15', 'spread': '11.42', 'groupId': 'BG003'}, {'value': '44.30', 'spread': '11.86', 'groupId': 'BG004'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '14', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '13', 'groupId': 'BG002'}, {'value': '17', 'groupId': 'BG003'}, {'value': '58', 'groupId': 'BG004'}]}, {'title': 'Male', 'measurements': [{'value': '26', 'groupId': 'BG000'}, {'value': '27', 'groupId': 'BG001'}, {'value': '25', 'groupId': 'BG002'}, {'value': '24', 'groupId': 'BG003'}, {'value': '102', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '16', 'groupId': 'BG004'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '32', 'groupId': 'BG000'}, {'value': '37', 'groupId': 'BG001'}, {'value': '35', 'groupId': 'BG002'}, {'value': '40', 'groupId': 'BG003'}, {'value': '144', 'groupId': 'BG004'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'White', 'categories': [{'measurements': [{'value': '30', 'groupId': 'BG000'}, {'value': '36', 'groupId': 'BG001'}, {'value': '29', 'groupId': 'BG002'}, {'value': '30', 'groupId': 'BG003'}, {'value': '125', 'groupId': 'BG004'}]}]}, {'title': 'African American', 'categories': [{'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}, {'value': '10', 'groupId': 'BG003'}, {'value': '28', 'groupId': 'BG004'}]}]}, {'title': 'Other', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '7', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Years of Regular Smoking', 'classes': [{'categories': [{'measurements': [{'value': '23.31', 'spread': '11.01', 'groupId': 'BG000'}, {'value': '26.38', 'spread': '13.24', 'groupId': 'BG001'}, {'value': '24.89', 'spread': '12.84', 'groupId': 'BG002'}, {'value': '26.46', 'spread': '12.17', 'groupId': 'BG003'}, {'value': '25.26', 'spread': '12.32', 'groupId': 'BG004'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Cigarettes Smoked Per Day', 'classes': [{'categories': [{'measurements': [{'value': '18.53', 'spread': '9.35', 'groupId': 'BG000'}, {'value': '19.41', 'spread': '15.09', 'groupId': 'BG001'}, {'value': '22.87', 'spread': '30.63', 'groupId': 'BG002'}, {'value': '20.04', 'spread': '13.85', 'groupId': 'BG003'}, {'value': '20.21', 'spread': '17.23', 'groupId': 'BG004'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'cigarettes per day', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Expired CO, ppm', 'classes': [{'categories': [{'measurements': [{'value': '5.18', 'spread': '4.17', 'groupId': 'BG000'}, {'value': '4.29', 'spread': '2.76', 'groupId': 'BG001'}, {'value': '4.78', 'spread': '3.46', 'groupId': 'BG002'}, {'value': '4.85', 'spread': '4.38', 'groupId': 'BG003'}, {'value': '4.78', 'spread': '3.69', 'groupId': 'BG004'}]}]}], 'paramType': 'MEAN', 'description': 'Measurements of CO in expired breath was the primary means of biochemical verification of smoking self-report during the study at each study visit. End-expiratory CO levels ≥10 ppm indicate current cigarette use, whereas levels of \\<10 ppm indicate abstinence.', 'unitOfMeasure': 'parts per million', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'FTND Score', 'classes': [{'categories': [{'measurements': [{'value': '5.40', 'spread': '2.07', 'groupId': 'BG000'}, {'value': '5.34', 'spread': '2.17', 'groupId': 'BG001'}, {'value': '5.39', 'spread': '1.94', 'groupId': 'BG002'}, {'value': '5.32', 'spread': '2.07', 'groupId': 'BG003'}, {'value': '5.36', 'spread': '2.06', 'groupId': 'BG004'}]}]}], 'paramType': 'MEAN', 'description': 'Fagerström Test for Nicotine Dependence (FTND) will determine the level of nicotine dependence. The scale score ranges from 0 to 10. An FTND score ≥6 indicates high nicotine dependence and a score of \\<6 indicates a low to moderate level of dependence', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'STANDARD_DEVIATION'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 345}}, 'statusModule': {'whyStopped': 'Study has been put on clinical hold by FDA', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2011-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-02', 'completionDateStruct': {'date': '2015-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-02-21', 'studyFirstSubmitDate': '2011-11-23', 'resultsFirstSubmitDate': '2016-12-15', 'studyFirstSubmitQcDate': '2011-11-23', 'lastUpdatePostDateStruct': {'date': '2017-04-06', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2017-02-21', 'studyFirstPostDateStruct': {'date': '2011-11-28', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2017-04-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2015-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Effects of EVP-6124 on 7-day Point-prevalence Smoking Abstinence', 'timeFrame': 'Week 1, 2, 4, 6, 8, 10, 12', 'description': 'Smoking abstinence is defined as a self-report of smoking no cigarettes for the past 7 days by time-line follow-back, confirmed by expired carbon monoxide (CO) \\<10 ppm and/or urine cotinine \\<50 ng/mL.'}, {'measure': 'Difference in Expired Carbon Monoxide (CO) Concentration From Baseline to End Point', 'timeFrame': 'Baseline, Weeks 1, 2, 4, 6, 8, 10, 12', 'description': 'CO concentration was measured at every visit.'}], 'secondaryOutcomes': [{'measure': 'Effects of EVP-6124 on Cognitive Performance as Measured by the Continuous Performance Test Hit Reaction Time', 'timeFrame': 'Baseline, week 1, week 12', 'description': "The Continuous Performance Test (CPT) is a measure of both vigilance/attentional control and response inhibition. During the task, subjects are required to press a button whenever a letter appears on the screen unless that letter is an 'X'. Measures of attentional control will serve as primary measure from this test. Baseline attentional impairment is associated with reduced odds of abstinence, abstinence differentially worsens performance on this measure in those with baseline attentional impairment, and NRT improves performance on a similar measure."}, {'measure': 'Safety and Tolerability of EVP-6124 Alone or Combined With NRT', 'timeFrame': 'Weeks 1-12', 'description': 'All AEs (adverse experiences) spontaneously reported by subjects and/or observed by investigator and evaluation of physical examinations, prior and concomitant medications, clinical laboratory tests, ECGs, and vital signs measurements. Data was collected at every visit and was analyzed as aggregate at the end of week 12'}, {'measure': 'Effects of EVP-6124 on Working Memory as Measured by the N-Back Task Reaction Time', 'timeFrame': 'Baseline, week 1, week 12', 'description': 'This task is a standard measure that can assess working memory performance under varying levels of task demand. Subjects are presented with a stream of stimuli, and the task is to decide for each stimulus whether it matches the one presented N items before. The processing load can be varied systematically by manipulating the value of N, which is expressed with changes in accuracy and reaction time. The number of errors as well as reaction times increase monotonically with increasing levels of N. The n-back task is sensitive to nicotine administration and abstinence effects. Here we present reaction time (RT)'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Nicotine Dependence', 'Smoking Cessation']}, 'descriptionModule': {'briefSummary': 'This study is designed to evaluate the initial evidence for efficacy of the investigational medicine, EVP-6124, to improve smoking cessation outcomes with and without a standard taper of nicotine replacement therapy (NRT) in healthy nicotine dependent smokers'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Self-report of smoking an average of ≥10 cigarettes/day for 6 months and expired carbon monoxide (CO) ≥10 parts per million (ppm) or urine cotinine ≥ 100 ng/mL at screening or self-report of smoking an average of 5-9 cigarettes/day for 6 months and a urine cotinine ≥30ng/ml at screening\n* Have a negative urine drug screen at screening\n* Fertile, sexually active subjects (males and females) must use an effective method of contraception from the first dose of study drug and for 3 months after the last dose of study drug\n* If female and capable of conception, must have a negative urine Human chorionic gonadotrophin (hCG) pregnancy test at screening and Day 1\n\nExclusion Criteria:\n\n* Have unstable medical illness with hospitalization for treatment likely within 6 months\n* Have life-threatening arrhythmia, cerebrovascular or cardiovascular event within 6 months of enrollment\n* Have liver function tests elevated \\>2.5 times the upper limit of normal range\n* Have a tumor or a seizure disorder\n* Currently using other tobacco- or nicotine-containing products and unwilling to try to quit\n* Have a 6-month history of substance use disorder other than nicotine or caffeine or major depressive disorder\n* Have a history of multiple adverse drug reactions\n* Non-response (past 3 months) to nicotine replacement therapy (NRT) \\>20 mg/day, bupropion \\>150 mg/day, or varenicline 2 mg/day for ≥4 weeks\n* Use of excluded concomitant medications\n* Hospitalization for any reason within 30 days of screening\n* Use of any investigational drug or device within 30 days of screening\n* Have clinically significant abnormal serum electrolytes\n* Have insufficiently controlled diabetes mellitus\n* Have renal insufficiency (serum creatinine \\>1.8 mg/dL)\n* Malignant tumor within the last 5 years, with the exception of squamous and basal cell carcinoma or cervical carcinoma in situ\n* Have a clinically significant cardiovascular abnormality on the screening EKG\n* Lifetime history of schizophrenia, bipolar disorder, post-traumatic stress disorder, bulimia, organic mental disorder, dementia, pervasive developmental disorder\n* Have untreated, clinically significant hypothyroidism or hyperthyroidism\n* Have a positive self-report of human immunodeficiency virus infection\n* Females who are pregnant or nursing\n* Any experimental drug currently or within 30 days before baseline\n* Have a serious risk of suicide\n* Have a screening electrocardiogram (ECG) with a corrected QT (QTc) interval using Bazett's formula \\>450 msec for males and \\>470 msec for females or the presence of any clinically significant cardiac abnormalities"}, 'identificationModule': {'nctId': 'NCT01480232', 'briefTitle': 'A Safety and Cognitive Function Study of EVP-6124 Versus Placebo in Subjects With Nicotine Dependence', 'organization': {'class': 'OTHER', 'fullName': 'Massachusetts General Hospital'}, 'officialTitle': 'Proof-of-Concept Study of EVP-6124, an Alpha-7 Nicotinic Acetylcholine Receptor Agonist, Versus Placebo in Subjects With Nicotine Dependence', 'orgStudyIdInfo': {'id': 'EVP-6124-014'}, 'secondaryIdInfos': [{'id': '1R01DA030992-01', 'link': 'https://reporter.nih.gov/quickSearch/1R01DA030992-01', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'EVP-6124 + NicoDerm (Active)', 'description': 'One EVP-6124 capsule ingested orally daily for 12 weeks (84 days) and one NicoDerm patch (Active) daily for first 6 weeks (42 days)', 'interventionNames': ['Drug: EVP-6124', 'Drug: NicoDerm Patch (Active)', 'Behavioral: Brief Supportive and Behavioral Treatment']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Placebo + NicoDerm (Active)', 'description': 'One placebo capsule ingested orally daily for 12 weeks (84 days) and one NicoDerm patch (Active) daily for first 6 weeks (42 days)', 'interventionNames': ['Drug: Placebo Capsule', 'Drug: NicoDerm Patch (Active)', 'Behavioral: Brief Supportive and Behavioral Treatment']}, {'type': 'EXPERIMENTAL', 'label': 'EVP-6124 + NRT Patch (Placebo)', 'description': 'One EVP-6124 capsule ingested orally daily for 12 weeks (84 days) and one NRT patch (Placebo) daily for first 6 weeks (42 days)', 'interventionNames': ['Drug: EVP-6124', 'Drug: NRT Patch (Placebo)', 'Behavioral: Brief Supportive and Behavioral Treatment']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo + NRT Patch (Placebo)', 'description': 'One placebo capsule ingested orally daily for 12 weeks (84 days) and one NRT patch (Placebo) daily for first 6 weeks (42 days)', 'interventionNames': ['Drug: Placebo Capsule', 'Drug: NRT Patch (Placebo)', 'Behavioral: Brief Supportive and Behavioral Treatment']}], 'interventions': [{'name': 'EVP-6124', 'type': 'DRUG', 'description': 'One EVP-6124 capsule ingested orally daily for 12 weeks (84 days)', 'armGroupLabels': ['EVP-6124 + NRT Patch (Placebo)', 'EVP-6124 + NicoDerm (Active)']}, {'name': 'Placebo Capsule', 'type': 'DRUG', 'description': 'One placebo capsule ingested orally daily for 12 weeks (84 days)', 'armGroupLabels': ['Placebo + NRT Patch (Placebo)', 'Placebo + NicoDerm (Active)']}, {'name': 'NicoDerm Patch (Active)', 'type': 'DRUG', 'description': 'One NicoDerm patch once daily for first 6 weeks (42 days). Dosage will taper from 21 mg (Weeks 1-3) to 14 mg (Weeks 4-5) to 7 mg (Week 6).', 'armGroupLabels': ['EVP-6124 + NicoDerm (Active)', 'Placebo + NicoDerm (Active)']}, {'name': 'NRT Patch (Placebo)', 'type': 'DRUG', 'description': 'One NRT patch (Placebo) daily for first 6 weeks (42 days).', 'armGroupLabels': ['EVP-6124 + NRT Patch (Placebo)', 'Placebo + NRT Patch (Placebo)']}, {'name': 'Brief Supportive and Behavioral Treatment', 'type': 'BEHAVIORAL', 'description': 'Brief, standard, manualized individual cognitive behavioral therapy intervention will be based on the Freedom from Smoking curriculum from the American Lung Association.', 'armGroupLabels': ['EVP-6124 + NRT Patch (Placebo)', 'EVP-6124 + NicoDerm (Active)', 'Placebo + NRT Patch (Placebo)', 'Placebo + NicoDerm (Active)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '02114', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Massachusetts General Hospital', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}], 'overallOfficials': [{'name': 'Anne Eden Evins, MD, MPH', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Massachusetts General Hospital'}, {'name': 'Maurizio Fava, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Massachusetts General Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'A. Eden Evins', 'class': 'OTHER'}, 'collaborators': [{'name': 'FORUM Pharmaceuticals Inc', 'class': 'INDUSTRY'}, {'name': 'National Institute on Drug Abuse (NIDA)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Director, Center for Addiction Medicine Massachusetts General Hospital', 'investigatorFullName': 'A. Eden Evins', 'investigatorAffiliation': 'Massachusetts General Hospital'}}}}