Varenicline Observational Investigation In The Cessation of Smoking

An observational study of Smoking Cessation, run by Pfizer at 52 sites in 4 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

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. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Smoking Cessation
What is being tested?: Varenicline
Type of treatment: Pill or oral medicine
How many people: 567 participants
Where: 52 sitesin 4 countries
Study dates: Nov 2007to Aug 2009
Phase: Observational
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Study population: 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. 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.

Who may be able to join

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.

Who cannot join

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.

Trial locations and contacts

52 sites in 4 countries.

Country

City, postcode or hospital

52 sites in 4 countries

Belgium26 sites

Pfizer Investigational Site
Alleur, 4432
Pfizer Investigational Site
Beerse, 2340
Pfizer Investigational Site
Braine-le-Comte, 7090
Pfizer Investigational Site
Brussels, 1070
Pfizer Investigational Site
Brussels, 1081
Pfizer Investigational Site
Brussels, 1160
Pfizer Investigational Site
Deinze, 9800
Pfizer Investigational Site
Edegem, 2650
Pfizer Investigational Site
Genk, 3600
Pfizer Investigational Site
Ghent, 9000
Pfizer Investigational Site
Habay-la-Neuve, 6720
Pfizer Investigational Site
Halen, 3545
Pfizer Investigational Site
Jette, 1090
Pfizer Investigational Site
Kortessem, 3720
Pfizer Investigational Site
Leuven, 3000
Pfizer Investigational Site
Libramont-Chevigny, 6800
Pfizer Investigational Site
Liège, 4000
Pfizer Investigational Site
Moerkerke, 8340
Pfizer Investigational Site
Monceau-sur-Sambre, 6031
Pfizer Investigational Site
Moorsel, 9310
Pfizer Investigational Site
Namur, 5000
Pfizer Investigational Site
Rijkevorsel, 2310
Pfizer Investigational Site
Vedrin, 5020
Pfizer Investigational Site
Vilvoorde, 1800
Pfizer Investigational Site
Yvoir, B-5530
Pfizer Investigational Site
Zedelgem, 8210

Other trials in Belgium

Greece10 sites

Pfizer Investigational Site
Alexandroupoli, 68100
Pfizer Investigational Site
Cholargós, Athens, 11527
Pfizer Investigational Site
Eksochi, Thessaloniki, 57010
Pfizer Investigational Site
Heraklion, Crete, 71110
Pfizer Investigational Site
Ilisia, Athens, 11528
Pfizer Investigational Site
Ioannina, 45500
Pfizer Investigational Site
Kavala, 65201
Pfizer Investigational Site
Larissa, 41 110
Pfizer Investigational Site
Marousi, Athens, 15126
Pfizer Investigational Site
Thessaloniki, 56249

Other trials in Greece

Hungary10 sites

Pfizer Investigational Site
Budapest, 1033
Pfizer Investigational Site
Budapest, 1134
Pfizer Investigational Site
Eger, 3300
Pfizer Investigational Site
Érd, 2030
Pfizer Investigational Site
Farkasgyepű, 8582
Pfizer Investigational Site
Hatvan, 3000
Pfizer Investigational Site
Nyíregyháza, 4400
Pfizer Investigational Site
Siófok, 8600
Pfizer Investigational Site
Szombathely, 9700
Pfizer Investigational Site
Zalaegerszeg, 8900

Other trials in Hungary

Slovenia6 sites

Pfizer Investigational Site
Cerknica, 1380
Pfizer Investigational Site
Domžale, 1230
Pfizer Investigational Site
Jesenice, 4270
Pfizer Investigational Site
Kranj, 4000
Pfizer Investigational Site
Ljubljana, 1000
Pfizer Investigational Site
Maribor, 2000

Other trials in Slovenia

About this study

Official title: Champix Observational Investigation In The Cessation of Smoking

Read the detailed description

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

Conditions: Smoking Cessation
Being tested: Varenicline
Medical subject headings: Smoking Cessation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

VareniclineDrug
Also called Champix, Chantix, CP-526,555
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.

Study groups in NCT00669240
Study group	Role	What they receive
1. Non-interventional		Patients prescribed varenicline in a non interventional manner. Receives: Drug: Varenicline

What is being measured

The primary outcome is the main question the study is designed to answer.

Number of Participants With Non-serious Adverse Events (AEs) or Serious Adverse Events (SAEs)
Non-serious AEs are any untoward medical occurrence in a clinical investigation (subject administered a product or medical device) observed or volunteered through 7 days after the last dose of study drug regardless of suspected causal relationship; SAEs are any untoward medical occurrence that results in death; is life-threatening; requires hospitalization or prolongation of hospitalization; results in disability or incapacity; congenital anomaly or birth defect observed or volunteered through 28 days after the last dose of study drug, regardless of suspected causal relationship.
Measured: Baseline through Week 12 or Week 24

Secondary outcomes (10)

Number of Participants Whose Smoking Status Was Known at the End of 12 Weeks
Number of participants who were determined to be a responder or a non-responder at the specified time point. (Responders are participants who answered "no" to both of the following 2 questions, and non-responders are participants who answered "yes" to at least 1 of the following 2 questions, on the Nicotine Use Inventory (NUI): 1) Has the subject smoked any cigarettes (even a puff) in the last 7 days? 2) Has the subject used any other tobacco products (for example, pipe, cigars, snuff, chew) in the last 7 days?)
Measured: Week 12
Number of Participants in Belgium Whose Smoking Status Was Known at the End of 12 Weeks and 24 Weeks
Number of participants in Belgium who were determined to be a responder or a non-responder at the specified time point. (Responders are participants who answered "no" to both of the following 2 questions, and non-responders are participants who answered "yes" to at least 1 of the following 2 questions, on the Nicotine Use Inventory (NUI): 1) Has the subject smoked any cigarettes (even a puff) in the last 7 days? 2) Has the subject used any other tobacco products (for example, pipe, cigars, snuff, chew) in the last 7 days?)
Measured: Week 12 and Week 24
Number of Treatment Responders at Week 12
Responders are participants who answered "no" to both of the following 2 questions on the Nicotine Use Inventory (NUI): 1) Has the subject smoked any cigarettes (even a puff) in the last 7 days? 2) Has the subject used any other tobacco products (for example, pipe, cigars, snuff, chew) in the last 7 days?
Measured: Week 12
Number of Treatment Responders in Belgium at Week 12 and at Week 24
Responders are participants who answered "no" to both of the following 2 questions on the Nicotine Use Inventory (NUI): 1) Has the subject smoked any cigarettes (even a puff) in the last 7 days? 2) Has the subject used any other tobacco products (for example, pipe, cigars, snuff, chew) in the last 7 days?
Measured: Week 12 and Week 24
Number of Participants With Smoking Cessation Assessments at Weekly Intervals From Week 3 Through Week 11
Assessment of smoking cessation (ie, not a single puff) in previous 7 days, at time points of routine review of patients per local clinical practice.
Measured: Weeks 3, 4, 5, 6, 7, 8, 9, 10, and 11
Number of Treatment Responders at Weekly Intervals From Week 3 Through Week 11
Responders are participants who answered "no" to the following 2 questions: 1) Has the subject smoked any cigarettes (even a puff) in the last 7 days? 2) Has the subject used any other tobacco products (for example, pipe, cigars, snuff, chew) in the last 7 days? Assessment conducted at specified time points only when usual for the local clinical practice.
Measured: Weeks 3, 4, 5, 6, 7, 8, 9, 10, and 11
Number of Participants for Whom a Maintenance Period of Varenicline Was Prescribed at the End of Week 12
A maintenance period was an additional period of varenicline treatment that could be prescribed at Week 12 by the attending primary care physician in routine clinical practice
Measured: Week 12
Number of Participants Who Received Varenicline, by Duration of Treatment in Days
Measured: Baseline through Week 12 or Week 24
Number of Participants Who Registered With LifeREWARDS On-line Behavioral Support Program
Number of participants who answered 'yes' to the question "Did you register with LifeREWARDS?" (LifeREWARDS not available in Greece.)
Measured: Week 12
Minnesota Nicotine Withdrawal Scale (MNWS) Subscale Scores for Participants in Belgium
Self-administered rating of intensity of nicotine withdrawal symptoms over past 24 hours; consists of 9 questions (urge to smoke, depressed mood, irritability, anxiety, difficulty concentrating, restlessness, increased appetite, difficulty going to sleep, difficulty staying asleep), each rated 0-4 (0=not at all, 1=slight, 2=moderate, 3=quite a bit, 4=extreme). Subscales: Negative affect domain (average of items 2-5); Insomnia domain (average of items 8 and 9); Urge to smoke (item 1); Restlessness (item 6); Increased appetite (item 7). Range 0-4 (higher score=greater intensity of symptoms)
Measured: Week 7 and Week 13 or 14 (Week 13/14)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Nov 2007Aug 2009

First posted30 Apr 2008 (estimated)
Study startNov 2007
Primary completionJun 2009
Study completionAug 2009

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (3)Papers the sponsor has linked to this study.
Other trials for Smoking CessationStudies of the same condition, open and under way.
More trials run by PfizerThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Observational
Observational model: Case only
Time perspective: Prospective
Enrolment: 567 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00669240
Sponsor's protocol ID: A3051085
Acronym: CHOICES
Status last verified: Jun 2015
First submitted: 25 Apr 2008
Last updated: 23 Jul 2015
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

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.
PubMed 23627193
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.
PubMed 22300423
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.
PubMed 21294601

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Enrolling by invitationObservational study
Using Smartwatches to Monitor Smoking in Real-life Situations
Smoking
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PROMETHEE: A Shared Interregional Tele-Tobacco Cessation Platform Embedded Within the IMPULSION Lung Cancer Screening Program
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Impacto 2.0: Mobile Smoking Cessation Across Texas
Cigarette Smoking, Smoking Cessation
Not yet recruiting
Smoking Cessation Program for Lao People With HIV
Smoking Cessation, HIV
RecruitingPhase 3
Studying NMDA and Sigma-1 in Smoking Cessation Treatment (SUMMIT)
Smoking Cessation

All Smoking Cessation trials

Study at a glance

From the registry record, last updated by the sponsor on 23 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Champix Observational Investigation In The Cessation of Smoking
ClinicalTrials.gov ID: NCT00669240
Acronym / sponsor ID: CHOICES / A3051085
Conditions: Smoking Cessation
Study type: Observational
Recruitment status: Completed
Enrolment: 567 participants (actual)
Lead sponsor: PfizerIndustry (pharma, biotech, devices)
Study start: Nov 2007
Primary completion: Jun 2009 (actual)
Study completion: Aug 2009 (actual)
First posted: 30 Apr 2008 (estimated)
Results: Posted 7 Jul 2010

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

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

Study design

Observational model: Case only
Time perspective: Prospective
Number of arms: 1

Arm	Type	Receives
1. Non-interventional	–	Drug: VareniclinePatients prescribed varenicline in a non interventional manner.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
Study population: 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. 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.

Key inclusion criteria (2 listed)

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.

Key exclusion criteria (1 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
VareniclineAlso: Champix, Chantix, CP-526,555According 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.	Drug	1. Non-interventional

Primary outcome

Number of Participants With Non-serious Adverse Events (AEs) or Serious Adverse Events (SAEs)
Time frame: Baseline through Week 12 or Week 24
Non-serious AEs are any untoward medical occurrence in a clinical investigation (subject administered a product or medical device) observed or volunteered through 7 days after the last dose of study drug regardless of suspected causal relationship; SAEs are any untoward medical occurrence that results in death; is life-threatening; requires hospitalization or prolongation of hospitalization; results in disability or incapacity; congenital anomaly or birth defect observed or volunteered through 28 days after the last dose of study drug, regardless of suspected causal relationship.

10 secondary outcomes

Number of Participants Whose Smoking Status Was Known at the End of 12 Weeks
Time frame: Week 12
Number of Participants in Belgium Whose Smoking Status Was Known at the End of 12 Weeks and 24 Weeks
Time frame: Week 12 and Week 24
Number of Treatment Responders at Week 12
Time frame: Week 12
Number of Treatment Responders in Belgium at Week 12 and at Week 24
Time frame: Week 12 and Week 24
Number of Participants With Smoking Cessation Assessments at Weekly Intervals From Week 3 Through Week 11
Time frame: Weeks 3, 4, 5, 6, 7, 8, 9, 10, and 11
Number of Treatment Responders at Weekly Intervals From Week 3 Through Week 11
Time frame: Weeks 3, 4, 5, 6, 7, 8, 9, 10, and 11
Number of Participants for Whom a Maintenance Period of Varenicline Was Prescribed at the End of Week 12
Time frame: Week 12
Number of Participants Who Received Varenicline, by Duration of Treatment in Days
Time frame: Baseline through Week 12 or Week 24
Number of Participants Who Registered With LifeREWARDS On-line Behavioral Support Program
Time frame: Week 12
Minnesota Nicotine Withdrawal Scale (MNWS) Subscale Scores for Participants in Belgium
Time frame: Week 7 and Week 13 or 14 (Week 13/14)

Results and safety

Results posted to the registry on 7 Jul 2010, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Varenicline	567	402

Primary outcome: Number of Participants With Non-serious Adverse Events (AEs) or Serious Adverse Events (SAEs)

Time frame: Baseline through Week 12 or Week 24. Number. Unit: participants

Measure	Varenicline n = 551
Non-serious AEs	131
SAEs	7

Population analysed: Safety population, which is identical to the all-subjects population: all enrolled subjects who received at least 1 dose (including partial doses) of varenicline; Week 24 if a maintenance period was prescribed.

10 secondary outcomes are reported in the full results.

Adverse events

Time frame: 12 weeks and up to 24 weeks for participants presribed maintenance period. Other adverse events reported at 1% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Varenicline	7 of 551 (1.3%)	93 of 551 (16.9%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 23 Jul 2015.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 23627193Boudrez 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.
Derived from this study: PubMed 22300423Gratziou 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.
Derived from this study: PubMed 21294601Boudrez 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.

Related trials for Smoking Cessation

Enrolling by invitationObservational study
Using Smartwatches to Monitor Smoking in Real-life Situations
Smoking
Not yet recruitingObservational study
PROMETHEE: A Shared Interregional Tele-Tobacco Cessation Platform Embedded Within the IMPULSION Lung Cancer Screening Program
Smoking Cessation, Lung Cancer Screening
Not yet recruiting
Impacto 2.0: Mobile Smoking Cessation Across Texas
Cigarette Smoking, Smoking Cessation
Not yet recruiting
Smoking Cessation Program for Lao People With HIV
Smoking Cessation, HIV
RecruitingPhase 3
Studying NMDA and Sigma-1 in Smoking Cessation Treatment (SUMMIT)
Smoking Cessation

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Pfizer CT.gov Call Center study director

Pfizer

52 sites in 4 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Smoking Cessation, run by Pfizer at 52 sites in 4 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 23 Jul 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 52 sites in Belgium, Greece, Hungary, Slovenia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 7 Jul 2010). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants With Non-serious Adverse Events (AEs) or Serious Adverse Events (SAEs) (time frame: Baseline through Week 12 or Week 24). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00669240, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jul 2015.