A Study To Evaluate The Efficacy And Safety Of Varenicline Compared To Placebo For Smoking Cessation Through Reduction
NCT ID: NCT01370356
Last Updated: 2014-09-01
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE4
1510 participants
INTERVENTIONAL
2011-07-31
2013-07-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
HEALTH_SERVICES_RESEARCH
DOUBLE
Study Groups
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Varenicline Tartrate
Varenicline Tartrate
Varenicline Tartrate oral tablets 2 (0.5mg) tablets twice a day for 24 weeks (first week titration)
Placebo
Placebo
Matching placebo 2 oral tablets twice a day for 24 weeks (first week titration)
Interventions
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Varenicline Tartrate
Varenicline Tartrate oral tablets 2 (0.5mg) tablets twice a day for 24 weeks (first week titration)
Placebo
Matching placebo 2 oral tablets twice a day for 24 weeks (first week titration)
Eligibility Criteria
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Inclusion Criteria
* Subjects must have smoked an average of at least 10 cigarettes per day during the past year and during the month prior to the screening visit, with no continuous period of abstinence greater than 3 months in the past year and who have an exhaled carbon monoxide (CO) \>10 ppm at screening.
* Subjects with mild to moderate depression or anxiety may be included if their condition is stable.
Exclusion Criteria
* Subjects with severe depression or anxiety.
* Subjects with psychosis, panic disorder, bipolar disorder, post traumatic stress disorder (PTSD), or schizophrenia.
* Subjects with alcohol or substance abuse or dependence (except nicotine) unless in full remission for at least 12 months.
18 Years
ALL
No
Sponsors
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Pfizer
INDUSTRY
Responsible Party
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Principal Investigators
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Pfizer CT.gov Call Center
Role: STUDY_DIRECTOR
Pfizer
Locations
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Pharmacology Research Institute
Encino, California, United States
Pharmacology Research Institute
Newport Beach, California, United States
Clinical Neuroscience Solutions, Inc.
Jacksonville, Florida, United States
Clinical Neuroscience Solutions, Inc.
Orlando, Florida, United States
Central Kentucky Research Associates, Inc.
Lexington, Kentucky, United States
Mayo Clinic
Rochester, Minnesota, United States
The Center for Pharmaceutical Research, P.C.
Kansas City, Missouri, United States
University of Nebraska Medical Center
Omaha, Nebraska, United States
CRI Worldwide, LLC
Marlton, New Jersey, United States
Clinical Research Integrity(CRI) Worldwide, LLC
Willingboro, New Jersey, United States
Central New York Clinical Research
Manlius, New York, United States
FutureSearch Clinical Trials, L.P.
Austin, Texas, United States
Benchmark Research
Fort Worth, Texas, United States
Healthfirst Medical Group
Fort Worth, Texas, United States
Australian Clinical Research Network
Maroubra, New South Wales, Australia
Brisbane South Clinical Research Centre
Carina Heights, Queensland, Australia
Royal Brisbane and Women's Hospital
Herston, Queensland, Australia
Emeritus Research
Malvern, Victoria, Australia
Office of Dr. Ronald Collette
Burnaby, British Columbia, Canada
James K. Lai, MD., Inc.
Vancouver, British Columbia, Canada
White Hills Medical Clinic
St. John's, Newfoundland and Labrador, Canada
Canadian Phase Onward Inc.
Toronto, Ontario, Canada
Manna Research
Toronto, Ontario, Canada
Clinique des Maladies Lipidiques de Quebec (CMLQ)
Québec, Quebec, Canada
SurGal Clinic s.r.o.
Brno, , Czechia
Fakultni nemocnice u sv. Anny v Brne
Brno, , Czechia
Krajska nemocnice Liberec a.s., Plicni oddeleni
Liberec, , Czechia
Mestska nemocnice Ostrava, Plicni oddeleni
Ostrava, , Czechia
Vseobecna fakultni nemocnice v Praze, III. interni klinika
Prague, , Czechia
Vseobecna fakultni nemocnice v Praze
Prague, , Czechia
Ustredni vojenska nemocnice Praha
Prague, , Czechia
Alexandria University
Alexandria, , Egypt
Ain Shams University Hospital
Cairo, , Egypt
El Fayoum university hospital
El Fayoum Qesm, , Egypt
Klinische Forschung Berlin
Berlin, , Germany
Klinische Forschung Berlin-Buch GmbH
Berlin, , Germany
Universitaetsklinikum Goettingen Zentrum Innere Medizin Abteilung Kardiologie und Pneumologie
Göttingen, , Germany
Universitaetsklinikum Goettingen, Zentrum Innere Medizin, Abteilung Kardiologie und Pneumologie
Göttingen, , Germany
Klinische Forschung Hamburg GmbH
Hamburg, , Germany
Medamed- Studienambulanz
Leipzig, , Germany
FOCUS Clinical Drug Development GmbH
Neuss, , Germany
Kubo Clinic
Yokohama, Kanagawa, Japan
Nagatsuta family clinic
Yokohama, Kanagawa, Japan
Sakakibara Clinic, Wakaumekai Medical Corporation
Yokohama, Kanagawa, Japan
Saino Clinic
Tokorozawa, Saitama, Japan
Tajima Clinic
Edogawa-ku, Tokyo, Japan
Hachiouji Junkanki clinic
Hachiōji, Tokyo, Japan
Arke Estudios Clinicos S.A.
México, D.f., Mexico
Centro Respiratorio de Mexico S.C.
México, D.f., Mexico
Clinica de Enfermedades Cronicas y de Procedimientos Especiales S.C.
Morelia, Michoacán, Mexico
Centro de Estudios Clinicos y Especialidades Medicas SC
Monterrey, Nuevo León, Mexico
Taichung Veterans General Hospital
Taichung, Taiwan, Taiwan
Chang Gung Medical Foundation-Linkou Branch
Kweishan Town, Taoyuan County, Taiwan
Kaohsiung Veterans General Hosptial
Kaohsiung City, , Taiwan
China Medical University Hospital
Taichung, , Taiwan
National Cheng Kung University Hospital
Tainan City, , Taiwan
National Taiwan University Hospital, Department of Family Medicine
Taipei, , Taiwan
Taipei Veterans General Hospital
Taipei, , Taiwan
Enchord Limited
Fowey, Cornwall, United Kingdom
The Alverton Practice
Penzance, Cornwall, United Kingdom
Knowle House Surgery
Plymouth, Devon, United Kingdom
Castlemilk Health Centre
Castlemilk, Glasgow, United Kingdom
Prince Philip Hospital
Dafen, Llanelli, United Kingdom
Hathaway Medical Centre
Chippenham, Wilts, United Kingdom
The Jenner Practice
London, , United Kingdom
Countries
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References
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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.
Hartmann-Boyce J, Theodoulou A, Farley A, Hajek P, Lycett D, Jones LL, Kudlek L, Heath L, Hajizadeh A, Schenkels M, Aveyard P. Interventions for preventing weight gain after smoking cessation. Cochrane Database Syst Rev. 2021 Oct 6;10(10):CD006219. doi: 10.1002/14651858.CD006219.pub4.
Nakamura M, Abe M, Ohkura M, Treadow J, Yu CR, Park PW. Efficacy of Varenicline for Cigarette Reduction Before Quitting in Japanese Smokers: A Subpopulation Analysis of the Reduce to Quit Trial. Clin Ther. 2017 Apr;39(4):863-872. doi: 10.1016/j.clinthera.2017.03.007. Epub 2017 Mar 30.
Ebbert JO, Hughes JR, West RJ, Rennard SI, Russ C, McRae TD, Treadow J, Yu CR, Dutro MP, Park PW. Effect of varenicline on smoking cessation through smoking reduction: a randomized clinical trial. JAMA. 2015 Feb 17;313(7):687-94. doi: 10.1001/jama.2015.280.
Related Links
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To obtain contact information for a study center near you, click here.
Other Identifiers
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REDUCE TO QUIT
Identifier Type: -
Identifier Source: secondary_id
A3051075
Identifier Type: -
Identifier Source: org_study_id
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