Clinical trial NCT01370356: A Study To Evaluate The Efficacy And Safety Of Varenicline Compared To Placebo For Smoking Cessation Through Reduction
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Smoking Cessation
Keywords: smoking reduction
smoking cessation
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2011-06-09
Enrollment: 1510
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Percentage of Participants With Carbon Monoxide (CO) Confirmed 10-Week Continuous Abstinence (CA) From Smoking
timeFrame: Week 15 - 24
Secondary outcomes:
measure: Percentage of Participants With CO Confirmed 4-Week CA From Smoking
timeFrame: Week 21 - 24
measure: Percentage of Participants With CO Confirmed Long Term CA From Smoking
timeFrame: Weeks 21 - 52
measure: Percentage of Participants With 7-Day Point Prevalence of Smoking Cessation
timeFrame: Week 12, 24, and 52
measure: Percentage of Participants With 4-Week Point Prevalence of Smoking Cessation
timeFrame: Week 52
Other outcomes:
Locations:
city: Encino
country: United States
facility: Pharmacology Research Institute
state: California
city: Newport Beach
country: United States
facility: Pharmacology Research Institute
state: California
city: Jacksonville
country: United States
facility: Clinical Neuroscience Solutions, Inc.
state: Florida
city: Orlando
country: United States
facility: Clinical Neuroscience Solutions, Inc.
state: Florida
city: Lexington
country: United States
facility: Central Kentucky Research Associates, Inc.
state: Kentucky
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
city: Kansas City
country: United States
facility: The Center for Pharmaceutical Research, P.C.
state: Missouri
city: Omaha
country: United States
facility: University of Nebraska Medical Center
state: Nebraska
city: Marlton
country: United States
facility: CRI Worldwide, LLC
state: New Jersey
city: Willingboro
country: United States
facility: Clinical Research Integrity(CRI) Worldwide, LLC
state: New Jersey
city: Manlius
country: United States
facility: Central New York Clinical Research
state: New York
city: Austin
country: United States
facility: FutureSearch Clinical Trials, L.P.
state: Texas
city: Fort Worth
country: United States
facility: Benchmark Research
state: Texas
city: Fort Worth
country: United States
facility: Healthfirst Medical Group
state: Texas
city: Maroubra
country: Australia
facility: Australian Clinical Research Network
state: New South Wales
city: Carina Heights
country: Australia
facility: Brisbane South Clinical Research Centre
state: Queensland
city: Herston
country: Australia
facility: Royal Brisbane and Women's Hospital
state: Queensland
city: Malvern
country: Australia
facility: Emeritus Research
state: Victoria
city: Burnaby
country: Canada
facility: Office of Dr. Ronald Collette
state: British Columbia
city: Vancouver
country: Canada
facility: James K. Lai, MD., Inc.
state: British Columbia
city: St. John's
country: Canada
facility: White Hills Medical Clinic
state: Newfoundland and Labrador
city: Toronto
country: Canada
facility: Canadian Phase Onward Inc.
state: Ontario
city: Toronto
country: Canada
facility: Manna Research
state: Ontario
city: Quebec
country: Canada
facility: Clinique des Maladies Lipidiques de Quebec (CMLQ)
city: Brno
country: Czech Republic
facility: SurGal Clinic s.r.o.
city: Brno
country: Czech Republic
facility: Fakultni nemocnice u sv. Anny v Brne
city: Liberec 1
country: Czech Republic
facility: Krajska nemocnice Liberec a.s., Plicni oddeleni
city: Ostrava 1
country: Czech Republic
facility: Mestska nemocnice Ostrava, Plicni oddeleni
city: Praha 2
country: Czech Republic
facility: Vseobecna fakultni nemocnice v Praze, III. interni klinika
city: Praha 2
country: Czech Republic
facility: Vseobecna fakultni nemocnice v Praze
city: Praha 6
country: Czech Republic
facility: Ustredni vojenska nemocnice Praha
city: Alexandria
country: Egypt
facility: Alexandria University
city: Cairo
country: Egypt
facility: Ain Shams University Hospital
city: El Fayoum
country: Egypt
facility: El Fayoum university hospital
city: Berlin
country: Germany
facility: Klinische Forschung Berlin
city: Berlin
country: Germany
facility: Klinische Forschung Berlin-Buch GmbH
city: Goettingen
country: Germany
facility: Universitaetsklinikum Goettingen Zentrum Innere Medizin Abteilung Kardiologie und Pneumologie
city: Goettingen
country: Germany
facility: Universitaetsklinikum Goettingen, Zentrum Innere Medizin, Abteilung Kardiologie und Pneumologie
city: Hamburg
country: Germany
facility: Klinische Forschung Hamburg GmbH
city: Leipzig
country: Germany
facility: Medamed- Studienambulanz
city: Neuss
country: Germany
facility: FOCUS Clinical Drug Development GmbH
city: Yokohama
country: Japan
facility: Kubo Clinic
state: Kanagawa
city: Yokohama
country: Japan
facility: Nagatsuta family clinic
state: Kanagawa
city: Yokohama
country: Japan
facility: Sakakibara Clinic, Wakaumekai Medical Corporation
state: Kanagawa
city: Tokorozawa
country: Japan
facility: Saino Clinic
state: Saitama
city: Edogawa-ku
country: Japan
facility: Tajima Clinic
state: Tokyo
city: Hachiouji
country: Japan
facility: Hachiouji Junkanki clinic
state: Tokyo
city: Mexico
country: Mexico
facility: Arke Estudios Clinicos S.A.
state: D.f.
city: Mexico
country: Mexico
facility: Centro Respiratorio de Mexico S.C.
state: D.f.
city: Morelia
country: Mexico
facility: Clinica de Enfermedades Cronicas y de Procedimientos Especiales S.C.
state: Michoacan
city: Monterrey
country: Mexico
facility: Centro de Estudios Clinicos y Especialidades Medicas SC
state: Nuevo Leon
city: Kweishan Town
country: Taiwan
facility: Chang Gung Medical Foundation-Linkou Branch
state: Taoyuan County
city: Kaohsiung
country: Taiwan
facility: Kaohsiung Veterans General Hosptial
city: Taichung
country: Taiwan
facility: China Medical University Hospital
city: Taichung
country: Taiwan
facility: Taichung Veterans General Hospital
city: Tainan
country: Taiwan
facility: National Cheng Kung University Hospital
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital, Department of Family Medicine
city: Taipei
country: Taiwan
facility: Taipei Veterans General Hospital
city: Fowey
country: United Kingdom
facility: Enchord Limited
state: Cornwall
city: Penzance
country: United Kingdom
facility: The Alverton Practice
state: Cornwall
city: Plymouth
country: United Kingdom
facility: Knowle House Surgery
state: Devon
city: Castlemilk
country: United Kingdom
facility: Castlemilk Health Centre
state: Glasgow
city: Dafen
country: United Kingdom
facility: Prince Philip Hospital
state: Llanelli
city: Chippenham
country: United Kingdom
facility: Hathaway Medical Centre
state: Wilts
city: London
country: United Kingdom
facility: The Jenner Practice
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.
citation: 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.