MedDataX Logo

Varenicline Observational Investigation In The Cessation of Smoking

NCT ID: NCT00669240

Last Updated: 2015-07-23

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

567 participants

Study Classification

OBSERVATIONAL

Study Start Date

2007-11-30

Study Completion Date

2009-08-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The purpose of this study is to determine the safety and efficacy of varenicline in the real-world environment of smokers attending primary care in routine clinical practice with the addition of being offered behavioral support "Life REWARDS"TM. This is a non-interventional study.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Study Evaluating The Efficacy Of Varenicline In Cessation Of Oral Smokeless Tobacco Use

NCT00717093

Tobacco Use Cessation
COMPLETED PHASE4

Assessment of Safety and Efficacy of Varenicline in Patients That Wish to Stop Smoking

NCT00594204

Smoking Cessation
COMPLETED PHASE4

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

NCT01244061

Smoking Cessation
COMPLETED PHASE4

Use of Varenicline for 4-weeks Prior to Quitting

NCT00789074

Tobacco Dependence Smoking Cessation
COMPLETED PHASE3

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

NCT01370356

Smoking Cessation
COMPLETED PHASE4

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Sampling Method Details: Patients as they come to surgeries for smoking cessation treatment.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Smoking Cessation

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

1. Non-interventional

Patients prescribed varenicline in a non interventional manner.

Varenicline

Intervention Type DRUG

According to the approved Summary of Product Characteristics (SmPC), patients will be required to orally take 0.5 mg once daily for the first 3 days and titrate up to 0.5 mg twice daily for days 4 - 7. From day 8 to the end of treatment patients should take 1 mg twice daily. Patients who cannot tolerate adverse effects of Champix may have the dose lowered temporarily or permanently to 0.5 mg twice daily. Patients should be treated for 12 weeks. Treatment should start 1 - 2 weeks prior to quitting smoking.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Varenicline

According to the approved Summary of Product Characteristics (SmPC), patients will be required to orally take 0.5 mg once daily for the first 3 days and titrate up to 0.5 mg twice daily for days 4 - 7. From day 8 to the end of treatment patients should take 1 mg twice daily. Patients who cannot tolerate adverse effects of Champix may have the dose lowered temporarily or permanently to 0.5 mg twice daily. Patients should be treated for 12 weeks. Treatment should start 1 - 2 weeks prior to quitting smoking.

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Champix, Chantix, CP-526,555

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* The patients enrolled should be of legal adult age who regularly smoke and of which the main tobacco product is cigarettes.
* The patients must be willing to make an attempt to stop smoking.

Exclusion Criteria

* All patients enrolled should meet the usual prescribing criteria for varenicline as per SmPC and should be entered into the trial at the Investigators discretion.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Pfizer

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Pfizer Investigational Site

Alleur, , Belgium

Site Status

Pfizer Investigational Site

Beerse, , Belgium

Site Status

Pfizer Investigational Site

Braine-le-Comte, , Belgium

Site Status

Pfizer Investigational Site

Brussels, , Belgium

Site Status

Pfizer Investigational Site

Brussels, , Belgium

Site Status

Pfizer Investigational Site

Brussels, , Belgium

Site Status

Pfizer Investigational Site

Deinze, , Belgium

Site Status

Pfizer Investigational Site

Edegem, , Belgium

Site Status

Pfizer Investigational Site

Genk, , Belgium

Site Status

Pfizer Investigational Site

Ghent, , Belgium

Site Status

Pfizer Investigational Site

Habay-la-Neuve, , Belgium

Site Status

Pfizer Investigational Site

Halen, , Belgium

Site Status

Pfizer Investigational Site

Jette, , Belgium

Site Status

Pfizer Investigational Site

Kortessem, , Belgium

Site Status

Pfizer Investigational Site

Leuven, , Belgium

Site Status

Pfizer Investigational Site

Libramont-Chevigny, , Belgium

Site Status

Pfizer Investigational Site

Liège, , Belgium

Site Status

Pfizer Investigational Site

Moerkerke, , Belgium

Site Status

Pfizer Investigational Site

Monceau-sur-Sambre, , Belgium

Site Status

Pfizer Investigational Site

Moorsel, , Belgium

Site Status

Pfizer Investigational Site

Namur, , Belgium

Site Status

Pfizer Investigational Site

Rijkevorsel, , Belgium

Site Status

Pfizer Investigational Site

Vedrin, , Belgium

Site Status

Pfizer Investigational Site

Vilvoorde, , Belgium

Site Status

Pfizer Investigational Site

Yvoir, , Belgium

Site Status

Pfizer Investigational Site

Zedelgem, , Belgium

Site Status

Pfizer Investigational Site

Cholargós, Athens, Greece

Site Status

Pfizer Investigational Site

Ilisia, Athens, Greece

Site Status

Pfizer Investigational Site

Marousi, Athens, Greece

Site Status

Pfizer Investigational Site

Heraklion, Crete, Greece

Site Status

Pfizer Investigational Site

Eksochi, Thessaloniki, Greece

Site Status

Pfizer Investigational Site

Alexandroupoli, , Greece

Site Status

Pfizer Investigational Site

Ioannina, , Greece

Site Status

Pfizer Investigational Site

Kavala, , Greece

Site Status

Pfizer Investigational Site

Larissa, , Greece

Site Status

Pfizer Investigational Site

Thessaloniki, , Greece

Site Status

Pfizer Investigational Site

Budapest, , Hungary

Site Status

Pfizer Investigational Site

Budapest, , Hungary

Site Status

Pfizer Investigational Site

Eger, , Hungary

Site Status

Pfizer Investigational Site

Érd, , Hungary

Site Status

Pfizer Investigational Site

Farkasgyepű, , Hungary

Site Status

Pfizer Investigational Site

Hatvan, , Hungary

Site Status

Pfizer Investigational Site

Nyíregyháza, , Hungary

Site Status

Pfizer Investigational Site

Siófok, , Hungary

Site Status

Pfizer Investigational Site

Szombathely, , Hungary

Site Status

Pfizer Investigational Site

Zalaegerszeg, , Hungary

Site Status

Pfizer Investigational Site

Cerknica, , Slovenia

Site Status

Pfizer Investigational Site

Domžale, , Slovenia

Site Status

Pfizer Investigational Site

Jesenice, , Slovenia

Site Status

Pfizer Investigational Site

Kranj, , Slovenia

Site Status

Pfizer Investigational Site

Ljubljana, , Slovenia

Site Status

Pfizer Investigational Site

Maribor, , Slovenia

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Belgium Greece Hungary Slovenia

References

Explore related publications, articles, or registry entries linked to this study.

Boudrez H, Hoengenaert JP, Nackaerts K, Messig M, Metcalfe M. Predictors of quit success in Belgian participants of a varenicline observational smoking cessation study. Acta Clin Belg. 2013 Jan-Feb;68(1):37-42. doi: 10.2143/ACB.68.1.2062718.

Reference Type DERIVED
PMID: 23627193 (View on PubMed)

Gratziou C, Gourgoulianis K, Pataka PA, Sykara GD, Messig M, Raju S. Varenicline as a smoking cessation aid in a Greek population: a subanalysis of an observational study. Tob Induc Dis. 2012 Feb 2;10(1):1. doi: 10.1186/1617-9625-10-1.

Reference Type DERIVED
PMID: 22300423 (View on PubMed)

Boudrez H, Gratziou C, Messig M, Metcalfe M. Effectiveness of varenicline as an aid to smoking cessation: results of an inter-European observational study. Curr Med Res Opin. 2011 Apr;27(4):769-75. doi: 10.1185/03007995.2011.557718. Epub 2011 Feb 4.

Reference Type DERIVED
PMID: 21294601 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

A3051085

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Smoke-Free Living Study
NCT00832806 COMPLETED PHASE1
Smoking Cessation Study In Healthy Adolescent Smokers
NCT01312909 COMPLETED PHASE4
Study of Varencline Effects on Cigarette Smoking Reward and Craving During a Model of Brief Quit Attempt
NCT00571805 WITHDRAWN PHASE1/PHASE2
Varenicline (Champix®) Special Investigation (Regulatory Post Marketing Commitment Plan)
NCT01061710 COMPLETED
A 52-Week Multicenter Study Evaluating the Safety and Efficacy of Varenicline for the Maintenance of Smoking Cessation
NCT00143286 COMPLETED PHASE3
Varenicline OTC Trial on Efficacy and Safety
NCT03557294 COMPLETED PHASE4
Drug Use Investigation Of Varenicline (Regulatory Post Marketing Commitment Plan)
NCT00772941 COMPLETED
A 52-Week Placebo-Controlled Study Evaluating the Safety of Varenicline
NCT00143299 COMPLETED PHASE3
ASIA CHOICES CHampix (Varenicline) Observational Investigation in the CEssation of Smoking
NCT00808015 COMPLETED
A Twelve-Week Study of Varenicline for Safety and Efficacy in Comparison With Placebo and Zyban for Smoking Cessation
NCT00141206 COMPLETED PHASE3
A Study to Evaluate the Safety and Efficacy of Three Doses of a Controlled Release Formulation of Varenicline for Smoking Cessation
NCT00741884 WITHDRAWN PHASE2
Varenicline for Light Smokers
NCT01639560 COMPLETED PHASE4
Post Marketing Surveillance Study of Champix in Smoking Cessation for Filipino Patients
NCT00794365 COMPLETED
Measuring Smoking Behaviors While Using Varenicline
NCT00948155 COMPLETED PHASE4
Randomized Study Comparing the Efficacy and Safety of Varenicline Tartrate to Placebo in Smoking Cessation When Subjects Are Allowed to Set Their Own Quit Date
NCT00691483 COMPLETED PHASE4
Effects of Varenicline on Brain Activity During Nicotine Abstinence
NCT00602927 COMPLETED NA
Varenicline for the Treatment of Smokeless Tobacco
NCT00813917 COMPLETED NA
Effects of Chantix on Relapse Prevention for Smoking Cessation
NCT00948649 COMPLETED PHASE4
A Seven-Week Dose-Ranging Study of CP-526,555 Compared With Placebo and Zyban for Smoking Cessation
NCT00150241 COMPLETED PHASE2
Varenicline (Chantix) Treatment for Waterpipe Smoking Cessation
NCT02575183 COMPLETED PHASE4
Effectiveness of Combination Varenicline and Oral Nicotine Replacement Therapy (COMBO)
NCT03722966 TERMINATED PHASE2
A Twelve-Week Study of Varenicline for Safety and Efficacy in Comparison With Placebo and Zyban for Smoking Cessation
NCT00143364 COMPLETED PHASE3
Efficacy of Varenicline on Smoking Cessation at the Acute Phase of an Exacerbation of Chronic Obstructive Pulmonary Disease
NCT01694732 COMPLETED PHASE3
Post Marketing Surveillance Study To Observe Safety And Efficacy Of Champix® Tablets
NCT00483002 COMPLETED
Efficacy and Safety of Varenicline in Smokers With Cardiovascular Disease Who Wish to Quit Smoking
NCT00282984 COMPLETED PHASE3