Smoking Cessation Clinical Trial
Official title:
A Phase 4, Multi-National, Randomized, Double-Blind, Placebo-Controlled Study To Evaluate The Efficacy And Safety Of Varenicline Compared To Placebo For Smoking Cessation Through Reduction
Verified date | August 2014 |
Source | Pfizer |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Food and Drug Administration |
Study type | Interventional |
This study will determine whether varenicline is safe and helps people to quit smoking through reduction when they are not willing/able to make an abrupt quit attempt.
Status | Completed |
Enrollment | 1510 |
Est. completion date | July 2013 |
Est. primary completion date | July 2013 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Male and female cigarette smokers over the age of 18 years who are not willing/able to quit smoking within the next month but who are willing to attempt to reduce their smoking to work toward a quit attempt within the next 3 months. - 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 a history of a suicide attempt or any suicidal behavior in the past two years. - 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. |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Health Services Research
Country | Name | City | State |
---|---|---|---|
Australia | Brisbane South Clinical Research Centre | Carina Heights | Queensland |
Australia | Royal Brisbane and Women's Hospital | Herston | Queensland |
Australia | Emeritus Research | Malvern | Victoria |
Australia | Australian Clinical Research Network | Maroubra | New South Wales |
Canada | Office of Dr. Ronald Collette | Burnaby | British Columbia |
Canada | Clinique des Maladies Lipidiques de Quebec (CMLQ) | Quebec | |
Canada | White Hills Medical Clinic | St. John's | Newfoundland and Labrador |
Canada | Canadian Phase Onward Inc. | Toronto | Ontario |
Canada | Manna Research | Toronto | Ontario |
Canada | James K. Lai, MD., Inc. | Vancouver | British Columbia |
Czech Republic | Fakultni nemocnice u sv. Anny v Brne | Brno | |
Czech Republic | SurGal Clinic s.r.o. | Brno | |
Czech Republic | Krajska nemocnice Liberec a.s., Plicni oddeleni | Liberec 1 | |
Czech Republic | Mestska nemocnice Ostrava, Plicni oddeleni | Ostrava 1 | |
Czech Republic | Vseobecna fakultni nemocnice v Praze | Praha 2 | |
Czech Republic | Vseobecna fakultni nemocnice v Praze, III. interni klinika | Praha 2 | |
Czech Republic | Ustredni vojenska nemocnice Praha | Praha 6 | |
Egypt | Alexandria University | Alexandria | |
Egypt | Ain Shams University Hospital | Cairo | |
Egypt | El Fayoum university hospital | El Fayoum | |
Germany | Klinische Forschung Berlin | Berlin | |
Germany | Klinische Forschung Berlin-Buch GmbH | Berlin | |
Germany | Universitaetsklinikum Goettingen Zentrum Innere Medizin Abteilung Kardiologie und Pneumologie | Goettingen | |
Germany | Universitaetsklinikum Goettingen, Zentrum Innere Medizin, Abteilung Kardiologie und Pneumologie | Goettingen | |
Germany | Klinische Forschung Hamburg GmbH | Hamburg | |
Germany | Medamed- Studienambulanz | Leipzig | |
Germany | FOCUS Clinical Drug Development GmbH | Neuss | |
Japan | Tajima Clinic | Edogawa-ku | Tokyo |
Japan | Hachiouji Junkanki clinic | Hachiouji | Tokyo |
Japan | Saino Clinic | Tokorozawa | Saitama |
Japan | Kubo Clinic | Yokohama | Kanagawa |
Japan | Nagatsuta family clinic | Yokohama | Kanagawa |
Japan | Sakakibara Clinic, Wakaumekai Medical Corporation | Yokohama | Kanagawa |
Mexico | Arke Estudios Clinicos S.A. | Mexico | D.f. |
Mexico | Centro Respiratorio de Mexico S.C. | Mexico | D.f. |
Mexico | Centro de Estudios Clinicos y Especialidades Medicas SC | Monterrey | Nuevo Leon |
Mexico | Clinica de Enfermedades Cronicas y de Procedimientos Especiales S.C. | Morelia | Michoacan |
Taiwan | Kaohsiung Veterans General Hosptial | Kaohsiung | |
Taiwan | Chang Gung Medical Foundation-Linkou Branch | Kweishan Town | Taoyuan County |
Taiwan | China Medical University Hospital | Taichung | |
Taiwan | Taichung Veterans General Hospital | Taichung | |
Taiwan | National Cheng Kung University Hospital | Tainan | |
Taiwan | National Taiwan University Hospital, Department of Family Medicine | Taipei | |
Taiwan | Taipei Veterans General Hospital | Taipei | |
United Kingdom | Castlemilk Health Centre | Castlemilk | Glasgow |
United Kingdom | Hathaway Medical Centre | Chippenham | Wilts |
United Kingdom | Prince Philip Hospital | Dafen | Llanelli |
United Kingdom | Enchord Limited | Fowey | Cornwall |
United Kingdom | The Jenner Practice | London | |
United Kingdom | The Alverton Practice | Penzance | Cornwall |
United Kingdom | Knowle House Surgery | Plymouth | Devon |
United States | FutureSearch Clinical Trials, L.P. | Austin | Texas |
United States | Pharmacology Research Institute | Encino | California |
United States | Benchmark Research | Fort Worth | Texas |
United States | Healthfirst Medical Group | Fort Worth | Texas |
United States | Clinical Neuroscience Solutions, Inc. | Jacksonville | Florida |
United States | The Center for Pharmaceutical Research, P.C. | Kansas City | Missouri |
United States | Central Kentucky Research Associates, Inc. | Lexington | Kentucky |
United States | Central New York Clinical Research | Manlius | New York |
United States | CRI Worldwide, LLC | Marlton | New Jersey |
United States | Pharmacology Research Institute | Newport Beach | California |
United States | University of Nebraska Medical Center | Omaha | Nebraska |
United States | Clinical Neuroscience Solutions, Inc. | Orlando | Florida |
United States | Mayo Clinic | Rochester | Minnesota |
United States | Clinical Research Integrity(CRI) Worldwide, LLC | Willingboro | New Jersey |
Lead Sponsor | Collaborator |
---|---|
Pfizer |
United States, Australia, Canada, Czech Republic, Egypt, Germany, Japan, Mexico, Taiwan, United Kingdom,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Percentage of Participants With Carbon Monoxide (CO) Confirmed 10-Week Continuous Abstinence (CA) From Smoking | Percentage of participants who remained abstinent from Week 15 to Week 24, inclusive, reporting no smoking and no use of nicotine-containing products since the last study visit or contact on the Nicotine Use Inventory (NUI) and confirmed by expired CO < 10 ppm at any time point (CO measurements conducted at the clinic visits) during Weeks 15 through 24, inclusive. Missing CO was imputed as negative (CO = 10 ppm). | Week 15 - 24 | No |
Secondary | Percentage of Participants With CO Confirmed 4-Week CA From Smoking | Percentage of participants who remained abstinent from Week 21 to Week 24, inclusive, reporting no smoking and no use of nicotine-containing products since the last study visit or contact on the NUI and confirmed by expired CO < 10 ppm at any time point (CO measurements conducted at the clinic visits) during Weeks 21 through 24, inclusive. Missing CO was imputed as negative (CO = 10 ppm). | Week 21 - 24 | No |
Secondary | Percentage of Participants With CO Confirmed Long Term CA From Smoking | Percentage of participants who remained abstinent from Week 21 to Week 52, inclusive, reporting no smoking and no use of nicotine-containing products since the last study visit or contact on the NUI and confirmed by expired CO < 10 ppm at any time point (CO measurements conducted at the clinic visits) during Weeks 21 through 52, inclusive. Missing CO was imputed as negative (CO = 10 ppm). | Weeks 21 - 52 | No |
Secondary | Percentage of Participants With 7-Day Point Prevalence of Smoking Cessation | The 7-day point prevalence of abstinence was defined as being abstinent from smoking and using tobacco products during the last 7 days at Week 12, 24, and 52. The participant`s smoking status and other nicotine use was evaluated based on the "last 7 days" questions on the NUI and confirmed by CO expiration. Responders were defined as those, who answered "no" to both questions ("Has the subject smoked any cigarettes (even a puff) in the last 7 days?"; and "Has the subject used any nicotine products and/or other tobacco.... in the last 7 days?") and whose expired CO < 10 ppm. Missing CO was imputed as negative (CO = 10 ppm). | Week 12, 24, and 52 | No |
Secondary | Percentage of Participants With 4-Week Point Prevalence of Smoking Cessation | The 4-week point prevalence of abstinence was defined as being abstinent from smoking and using tobacco products during the last 4 weeks of the study. The participant`s smoking status and other nicotine use was evaluated based on the "last 4 weeks" questions on the NUI and confirmed by CO expiration. Responders were defined as those, who answered "no" to both questions ("Has the subject smoked any cigarettes (even a puff) in the last 4 weeks?"; and "Has the subject used any nicotine products and/or other tobacco.... in the last 4 weeks?") and whose expired CO < 10 ppm. Missing CO was imputed as negative (CO = 10 ppm). | Week 52 | No |
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