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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01370356
Other study ID # A3051075
Secondary ID REDUCE TO QUIT
Status Completed
Phase Phase 4
First received June 8, 2011
Last updated August 29, 2014
Start date July 2011
Est. completion date July 2013

Study information

Verified date August 2014
Source Pfizer
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial Summary

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.


Recruitment information / eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Health Services Research


Related Conditions & MeSH terms


Intervention

Drug:
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)

Locations

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

Sponsors (1)

Lead Sponsor Collaborator
Pfizer

Countries where clinical trial is conducted

United States,  Australia,  Canada,  Czech Republic,  Egypt,  Germany,  Japan,  Mexico,  Taiwan,  United Kingdom, 

Outcome

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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