Varenicline Observational Investigation In The Cessation of Smoking (CHOICES)

• Number of Participants Whose Smoking Status Was Known at the End of 12 Weeks [ Time Frame: Week 12 ] [ Designated as safety issue: No ]
  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?)
• 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 ] [ Designated as safety issue: No ]
  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?)
• Number of Treatment Responders at Week 12 [ Time Frame: Week 12 ] [ Designated as safety issue: No ]
  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?
• Number of Treatment Responders in Belgium at Week 12 and at Week 24 [ Time Frame: Week 12 and Week 24 ] [ Designated as safety issue: No ]
  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?
• 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 ] [ Designated as safety issue: No ]
  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.
• 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 ] [ Designated as safety issue: No ]
  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.
• Number of Participants for Whom a Maintenance Period of Varenicline Was Prescribed at the End of Week 12 [ Time Frame: Week 12 ] [ Designated as safety issue: No ]
  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
• Number of Participants Who Received Varenicline, by Duration of Treatment in Days [ Time Frame: Baseline through Week 12 or Week 24 ] [ Designated as safety issue: Yes ]
• Number of Participants Who Registered With LifeREWARDS On-line Behavioral Support Program [ Time Frame: Week 12 ] [ Designated as safety issue: No ]
  Number of participants who answered 'yes' to the question "Did you register with LifeREWARDS?" (LifeREWARDS not available in Greece.)
• Minnesota Nicotine Withdrawal Scale (MNWS) Subscale Scores for Participants in Belgium [ Time Frame: Week 7 and Week 13 or 14 (Week 13/14) ] [ Designated as safety issue: No ]
  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)

• To determine smoking history, the reasons for quitting smoking, the reasons for withdrawing or discontinuing from the study, the dosing period for all patients and if LifeREWARDS was used. [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
• To summarise the smoking related concurrent illnesses and cardiovascular risk factors. [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
• To determine the proportion of patients in routine clinical practice whose smoking status is known at the end of the study period. [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
• To determine the success rates for smoking cessation (i.e. not a single puff) in the 7 day continuous period between weeks 11 and 12. [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
• To determine when routine review of patients takes place in practice and record smoking cessation rate (i.e. not a single puff) in the previous 7 days. [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

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.

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

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.

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.