Varenicline Observational Investigation In The Cessation of Smoking

Study Overview
=================
Brief 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 REWARDSTM. This is a non-interventional study.

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

Official Title
-----------------
Champix Observational Investigation In The Cessation of Smoking

Conditions
-----------------
Smoking Cessation

Intervention / Treatment
-----------------
* Drug: Varenicline


Participation Criteria
=================
Eligibility Criteria
-----------------
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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| 1. Non-interventional<br>Patients prescribed varenicline in a non interventional manner. | Drug: Varenicline<br>* 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.<br>* Other names: Champix, Chantix, CP-526,555;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| Number of Participants Who Received Varenicline, by Duration of Treatment in Days |  | 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.) | 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) | Week 7 and Week 13 or 14 (Week 13/14) |