Ignite Creation Date:
2025-12-25 @ 12:34 AM
Ignite Modification Date:
2025-12-26 @ 4:48 PM
Study NCT ID:
NCT00141167
Status:
COMPLETED
Last Update Posted:
2010-09-06
First Post:
2005-08-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Twelve-Week Study of Varenicline for Safety and Efficacy in Comparison With Placebo for Smoking Cessation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D016540', 'term': 'Smoking Cessation'}], 'ancestors': [{'id': 'D015438', 'term': 'Health Behavior'}, {'id': 'D001519', 'term': 'Behavior'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000068580', 'term': 'Varenicline'}], 'ancestors': [{'id': 'D001552', 'term': 'Benzazepines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D011810', 'term': 'Quinoxalines'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 250}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2005-02'}, 'statusVerifiedDate': '2010-09', 'completionDateStruct': {'date': '2006-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2010-09-03', 'studyFirstSubmitDate': '2005-08-30', 'studyFirstSubmitQcDate': '2005-08-30', 'lastUpdatePostDateStruct': {'date': '2010-09-06', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2005-09-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': '4 week continuous quit rate ( 4 week CQR ) for weeks 9 -12'}], 'secondaryOutcomes': [{'measure': 'Continuous abstinence rate weeks 9-24'}, {'measure': 'Long-term Quit Rate at week 24'}, {'measure': '7 day point prevalence week 12 and 24'}, {'measure': 'Results of Minnesota Nicotine Withdrawal Scale'}, {'measure': 'Brief Questionnaire of Smoking Urges'}, {'measure': 'Smoking Effects Inventory'}]}, 'conditionsModule': {'conditions': ['Smoking Cessation']}, 'referencesModule': {'references': [{'pmid': '37142273', 'type': 'DERIVED', 'citation': 'Livingstone-Banks J, Fanshawe TR, Thomas KH, Theodoulou A, Hajizadeh A, Hartman L, Lindson N. Nicotine receptor partial agonists for smoking cessation. Cochrane Database Syst Rev. 2023 May 5;5(5):CD006103. doi: 10.1002/14651858.CD006103.pub8.'}, {'pmid': '17692719', 'type': 'DERIVED', 'citation': 'Tsai ST, Cho HJ, Cheng HS, Kim CH, Hsueh KC, Billing CB Jr, Williams KE. A randomized, placebo-controlled trial of varenicline, a selective alpha4beta2 nicotinic acetylcholine receptor partial agonist, as a new therapy for smoking cessation in Asian smokers. Clin Ther. 2007 Jun;29(6):1027-39. doi: 10.1016/j.clinthera.2007.06.011.'}]}, 'descriptionModule': {'briefSummary': 'The primary purpose of this study is to evaluate the safety and efficacy of varenicline given for a twelve week treatment period in comparison with placebo for smoking cessation.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Subjects must have smoked an average of at least 10 cigarettes per day during the past year and over the month prior to the screening visit, with no period of abstinence greater than 3 months in the past year.\n\nExclusion Criteria:\n\n* Subjects who have used bupropion, Zyban, or Wellbutrin previously.'}, 'identificationModule': {'nctId': 'NCT00141167', 'briefTitle': 'A Twelve-Week Study of Varenicline for Safety and Efficacy in Comparison With Placebo for Smoking Cessation', 'nctIdAliases': ['NCT00155298'], 'organization': {'class': 'INDUSTRY', 'fullName': 'Pfizer'}, 'officialTitle': 'A Twelve-Week, Double-Blind, Placebo-Controlled, Multicenter Study With Follow-up Evaluating the Safety and Efficacy of Varenicline Tartrate 1 MG BID for Smoking Cessation', 'orgStudyIdInfo': {'id': 'A3051045'}}, 'armsInterventionsModule': {'interventions': [{'name': 'varenicline', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'zip': '431-070', 'city': 'Anyang-si', 'state': 'Gyeonggi-do', 'country': 'South Korea', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 37.3925, 'lon': 126.92694}}, {'zip': '700-712', 'city': 'Daegu', 'country': 'South Korea', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 35.87028, 'lon': 128.59111}}, {'zip': '100-032', 'city': 'Seoul', 'country': 'South Korea', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'zip': '110-744', 'city': 'Seoul', 'country': 'South Korea', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'zip': '138-736', 'city': 'Seoul', 'country': 'South Korea', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'zip': '333', 'city': 'Kweishan', 'state': 'Taoyuan County', 'country': 'Taiwan', 'facility': 'Pfizer Investigational Site'}, {'zip': '970', 'city': 'Hualien City', 'country': 'Taiwan', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 23.97694, 'lon': 121.60444}}, {'zip': '813', 'city': 'Kaohsiung City', 'country': 'Taiwan', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 22.61626, 'lon': 120.31333}}, {'zip': '40705', 'city': 'Taichung', 'country': 'Taiwan', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 24.1469, 'lon': 120.6839}}, {'zip': '100', 'city': 'Taipei', 'country': 'Taiwan', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 25.05306, 'lon': 121.52639}}], 'overallOfficials': [{'name': 'Pfizer CT.gov Call Center', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Pfizer'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Pfizer', 'class': 'INDUSTRY'}}}}