Varenicline Observational Investigation In The Cessation of Smoking
- Registration Number
- NCT00669240
- Lead Sponsor
- Pfizer
- 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 REWARDS"TM. This is a non-interventional study.
- Detailed Description
Sampling Method Details: Patients as they come to surgeries for smoking cessation treatment.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 567
- 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.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description 1. Non-interventional Varenicline Patients prescribed varenicline in a non interventional manner.
- Primary Outcome Measures
Name Time Method Number of Participants With Non-serious Adverse Events (AEs) or Serious Adverse Events (SAEs) 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.
- Secondary Outcome Measures
Name Time Method Number of Treatment Responders in Belgium at Week 12 and at Week 24 Week 12 and 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?
Number of Participants Whose Smoking Status Was Known at the End of 12 Weeks Week 12 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 Week 12 and Week 24 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 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?
Number of Participants With Smoking Cessation Assessments at Weekly Intervals From Week 3 Through Week 11 Weeks 3, 4, 5, 6, 7, 8, 9, 10, and 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.
Number of Treatment Responders at Weekly Intervals From Week 3 Through Week 11 Weeks 3, 4, 5, 6, 7, 8, 9, 10, and 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.
Number of Participants for Whom a Maintenance Period of Varenicline Was Prescribed at the End of Week 12 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
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 Week 12 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 Week 7 and Week 13 or 14 (Week 13/14) 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)
Trial Locations
- Locations (1)
Pfizer Investigational Site
🇸🇮Maribor, Slovenia