A Multi-National Study To Assess How Effective And Safe The Smoking Cessation Medicine Varenicline Is In Smokers Who Have Already Tried Varenicline In The Past As A Prescription Medicine From Their Usual Healthcare Provider
- Registration Number
- NCT01244061
- Lead Sponsor
- Pfizer
- Brief Summary
The main purpose of this study is to compare the effectiveness and safety of the re-treatment of smokers with varenicline with placebo for smoking cessation during the last 4 weeks of a 12 week course of treatment. The study will also assess whether smokers remain abstinent at Week 24 (12 weeks after the end of treatment) and Week 52 (40 weeks after the end of treatment).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 498
- Smokers aged 18 years or above and wanting to stop smoking
- Smokers who have smoked an average of at least 10 cigarettes per day over the last 4 weeks
- Smokers who have tried before to stop smoking at least once with varenicline, and who took varenicline for at least 2 weeks
- The last attempt to stop smoking must be at least 3 months before entering the study
- Individuals who have not tolerated varenicline well previously, or who have a current or prior medical or psychiatric history that would make entry into the trial inadvisable
- Individuals who have previously participated in clinical trials of varenicline
- Individuals who have been participating in another smoking cessation trial within the last 3 months, or other drug trial within the last 30 days
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo Placebo - Varenicline Varenicline -
- Primary Outcome Measures
Name Time Method Continuous Abstinence Rate (CAR) From Week 9 Through Week 12 Week 9 through Week 12 The percentage of participants who, from Week 9 through Week 12, reported no smoking and no use of other nicotine-containing products since the last study visit/last contact (on the Nicotine Use Inventory) and who did not have carbon monoxide (CO)\> 10ppm at any visits during this time frame.
- Secondary Outcome Measures
Name Time Method CAR From Week 9 Through Week 52 Week 9 through Week 52 The percentage of participants who, from Week 9 through Week 52, reported no smoking (Weeks 9 through 52) and no use of other nicotine-containing products (Weeks 9 through 12), or no use of other tobacco products (Weeks 13 through 52), since the last study visit/last contact (on the Nicotine Use Inventory) and who did not have CO \>10 ppm at any of these visits during this time frame.
CAR From Week 9 Through Week 24 Week 9 through Week 24 The percentage of participants who, from Week 9 through Week 24, reported no smoking (Weeks 9 through 24) and no use of other nicotine-containing products (Weeks 9 through 12), or no use of other tobacco products (Weeks 13 through 24), since the last study visit/last contact (on the Nicotine Use Inventory) and who did not have CO \>10 ppm at any of these visits during this time frame.
7-day Point Prevalence (PP) of Abstinence at Weeks 12, 24, and 52 Weeks 12, 24 and 52 The secondary endpoint of 7-day point prevalence of smoking cessation was determined by evaluating a participant's cigarette smoking status, and other nicotine (and/or other tobacco) use, based on the "last 7 days" questions in the Nicotine Use Inventory. Additionally, a participant was not considered a responder if the expired CO was \>10 ppm at the time point being summarized. Participants were considered responders independently at each visit.
Trial Locations
- Locations (37)
Ronald Reagan University of California Los Angeles Medical Center
🇺🇸Los Angeles, California, United States
Royal Brisbane and Women's Hospital
🇦🇺Herston, Queensland, Australia
Canadian Phase Onward Inc.
🇨🇦Toronto, Ontario, Canada
Clinical Research Associates, Inc.
🇺🇸Nashville, Tennessee, United States
The University of Maryland
🇺🇸College Park, Maryland, United States
Universitaire Ziekenhuizen Leuven/Pneumologie
🇧🇪Leuven, Belgium
Centre Hospitalier Universitaire de Liege
🇧🇪Liege, Belgium
The Center for Pharmaceutical Research, PC
🇺🇸Kansas City, Missouri, United States
AusTrials Australia
🇦🇺Sherwood, Queensland, Australia
Central Kentucky Research Associates, Inc.
🇺🇸Lexington, Kentucky, United States
Avail Clinical Research, LLC
🇺🇸DeLand, Florida, United States
CHU de la Cavale Blanche
🇫🇷Brest, France
Universitair Ziekenhuis Antwerpen, Afdeling Pneumologie
🇧🇪Edegem, Belgium
Emeritus Research
🇦🇺Malvern, Victoria, Australia
Klinische Forschung Hamburg GmbH
🇩🇪Hamburg, Germany
University of California Los Angeles David Geffen School of Medicine
🇺🇸Los Angeles, California, United States
Cliniques Universitaires U.C.L. de Mont-Godinne/Laboratoire
🇧🇪Yvoir, Belgium
Australian Clinical Research Network
🇦🇺Maroubra, New South Wales, Australia
Hopital Arnaud de Villeneuve
🇫🇷Montpellier Cedex 5, France
Clinique des maladies Lipidiques de Quebec
🇨🇦Quebec, Canada
Office of Dr. Ronald Collette
🇨🇦Burnaby, British Columbia, Canada
Ludwig Maximilians-Universitaet Muenchen
🇩🇪Muenchen, Germany
Synexus Thames Valley Clinical Research Centre
🇬🇧Reading, Berks, United Kingdom
Klinische Forschung Berlin
🇩🇪Berlin, Germany
Mestska nemocnice Ostrava, Plicni oddeleni
🇨🇿Ostrava 1, Czech Republic
CHU Côte de Nacre, Unité de Coordination de Tabacologie
🇫🇷Caen, France
Synexus, Merseyside Clinical Research Centre
🇬🇧Liverpool, United Kingdom
Synexus Scotland Clinical Research Centre
🇬🇧Glasgow, United Kingdom
Oregon Health and Science University
🇺🇸Portland, Oregon, United States
Krajska nemocnice Liberec a.s., Plicni oddeleni
🇨🇿Liberec 1, Czech Republic
Vseobecna fakultni nemocnice v Praze
🇨🇿Praha 2, Czech Republic
Universitaetsklinikum Goettingen Zentrum Innere Medizin Abteilung Kardiologie und Pneumologie
🇩🇪Goettingen, Germany
FOCUS Clinical Drug Development GmbH
🇩🇪Neuss, Germany
Synexus Lancashire Clinical Research Centre
🇬🇧Chorley, Lancashire, United Kingdom
William Harvey Research Institute,
🇬🇧London, United Kingdom
Fakultni nemocnice Brno
🇨🇿Brno, Czech Republic
White Hills Medical Clinic
🇨🇦St. John's, Newfoundland and Labrador, Canada