Varenicline Observational Investigation In The Cessation of Smoking

Smoking Cessation Clinical Trial

— CHOICES  

Official title:

Champix Observational Investigation In The Cessation of Smoking

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00669240
• Other study ID #: A3051085
• Status: Completed
• Phase: N/A
• First received: April 25, 2008
• Last updated: June 30, 2015
• Start date: November 2007
• Est. completion date: August 2009

Study information

• Verified date: June 2015
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Health authority: Greece: Ethics Committee
• Study type: Observational

Clinical 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.

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 567
• Est. completion date: August 2009
• Est. primary completion date: June 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Smoking Cessation

Intervention

Drug:
• 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.

Locations

Country	Name	City	State
Belgium	Pfizer Investigational Site	Alleur
Belgium	Pfizer Investigational Site	Beerse
Belgium	Pfizer Investigational Site	Braine le Comte
Belgium	Pfizer Investigational Site	Bruxelles
Belgium	Pfizer Investigational Site	Bruxelles
Belgium	Pfizer Investigational Site	Bruxelles
Belgium	Pfizer Investigational Site	Deinze
Belgium	Pfizer Investigational Site	Edegem
Belgium	Pfizer Investigational Site	Genk
Belgium	Pfizer Investigational Site	Gent
Belgium	Pfizer Investigational Site	Habay-la-Neuve
Belgium	Pfizer Investigational Site	Halen
Belgium	Pfizer Investigational Site	Jette
Belgium	Pfizer Investigational Site	Kortessem
Belgium	Pfizer Investigational Site	Leuven
Belgium	Pfizer Investigational Site	Libramont-Chevigny
Belgium	Pfizer Investigational Site	Liege
Belgium	Pfizer Investigational Site	Moerkerke
Belgium	Pfizer Investigational Site	Monceau-sur-Sambre
Belgium	Pfizer Investigational Site	Moorsel
Belgium	Pfizer Investigational Site	Namur
Belgium	Pfizer Investigational Site	Rijkevorsel
Belgium	Pfizer Investigational Site	Vedrin
Belgium	Pfizer Investigational Site	Vilvoorde
Belgium	Pfizer Investigational Site	Yvoir
Belgium	Pfizer Investigational Site	Zedelgem
Greece	Pfizer Investigational Site	Alexandroupoli
Greece	Pfizer Investigational Site	Exohi	Thessaloniki
Greece	Pfizer Investigational Site	Herakleion	Crete
Greece	Pfizer Investigational Site	Holargos	Athens
Greece	Pfizer Investigational Site	Ilisia	Athens
Greece	Pfizer Investigational Site	Ioannina
Greece	Pfizer Investigational Site	Kavala
Greece	Pfizer Investigational Site	Larissa
Greece	Pfizer Investigational Site	Marousi	Athens
Greece	Pfizer Investigational Site	Thessaloniki
Hungary	Pfizer Investigational Site	Budapest
Hungary	Pfizer Investigational Site	Budapest
Hungary	Pfizer Investigational Site	Eger
Hungary	Pfizer Investigational Site	Erd
Hungary	Pfizer Investigational Site	Farkasgyepu
Hungary	Pfizer Investigational Site	Hatvan
Hungary	Pfizer Investigational Site	Nyiregyhaza
Hungary	Pfizer Investigational Site	Siofok
Hungary	Pfizer Investigational Site	Szombathely
Hungary	Pfizer Investigational Site	Zalaegerszeg
Slovenia	Pfizer Investigational Site	Cerknica
Slovenia	Pfizer Investigational Site	Domzale
Slovenia	Pfizer Investigational Site	Jesenice
Slovenia	Pfizer Investigational Site	Kranj
Slovenia	Pfizer Investigational Site	Ljubljana
Slovenia	Pfizer Investigational Site	Maribor

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Countries where clinical trial is conducted

Belgium,  Greece,  Hungary,  Slovenia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Baseline through Week 12 or Week 24	Yes
Secondary	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?)	Week 12	No
Secondary	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?)	Week 12 and Week 24	No
Secondary	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?	Week 12	No
Secondary	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?	Week 12 and Week 24	No
Secondary	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.	Weeks 3, 4, 5, 6, 7, 8, 9, 10, and 11	No
Secondary	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.	Weeks 3, 4, 5, 6, 7, 8, 9, 10, and 11	No
Secondary	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	Week 12	No
Secondary	Number of Participants Who Received Varenicline, by Duration of Treatment in Days		Baseline through Week 12 or Week 24	Yes
Secondary	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.)	Week 12	No
Secondary	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)	Week 7 and Week 13 or 14 (Week 13/14)	No

External Links

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