A Study To Evaluate The Efficacy And Safety Of Varenicline Compared To Placebo For Smoking Cessation Through Reduction

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

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

• Smoking Cessation

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

External Links

•   To obtain contact information for a study center near you, click here.