Smoking Cessation
Conditions
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.
Interventions
DRUGVarenicline
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.
Sponsors
Pfizer
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 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? |
| 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) |
| 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.) |
| 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. |
Countries
Belgium, Greece, Hungary, Slovenia
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Varenicline According to the approved Summary of Product Characteristics (SmPC), participants were required to take 0.5 milligram (mg) orally 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, participants should have taken 1 mg twice daily. Participants who cannot tolerate adverse effects of Champix could have the dose lowered temporarily or permanently to 0.5 mg twice daily. Participants were to be treated for 12 weeks, at which time a maintenance period of 12 weeks could be prescribed. Treatment was to start 1-2 weeks prior to quitting smoking. | 551 |
| Total | 551 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 21 |
| Overall Study | Enrolled but no dosing record | 1 |
| Overall Study | Enrolled but not treated | 15 |
| Overall Study | Lack of Efficacy | 33 |
| Overall Study | Lost to Follow-up | 34 |
| Overall Study | Other | 19 |
| Overall Study | Withdrawal by Subject | 42 |
Baseline characteristics
| Characteristic | Varenicline |
|---|---|
| Age, Customized <55 years | 415 participants |
| Age, Customized >=55 years and <=65 years | 107 participants |
| Age, Customized >65 years | 26 participants |
| Age, Customized Unspecified | 3 participants |
| Average number of cigarettes participants smoked per day | 25.3 cigarettes per day |
| Number of participants with quit smoking history | 426 participants |
| Number of years participants smoked | 27.0 years |
| Reasons for quitting smoking Body image / appearance | 84 participants |
| Reasons for quitting smoking Family / friends | 255 participants |
| Reasons for quitting smoking Health reasons | 495 participants |
| Reasons for quitting smoking Money / cost | 159 participants |
| Reasons for quitting smoking Smoking ban in public places | 35 participants |
| Sex/Gender, Customized Female | 248 participants |
| Sex/Gender, Customized Male | 295 participants |
| Sex/Gender, Customized Unspecified | 8 participants |
| Smoking-related concurrent illnesses and cardiovascular risk factors Cardiovascular disease | 54 participants |
| Smoking-related concurrent illnesses and cardiovascular risk factors Chronic obstructive pulmonary disease (COPD) | 100 participants |
| Smoking-related concurrent illnesses and cardiovascular risk factors Depression | 52 participants |
| Smoking-related concurrent illnesses and cardiovascular risk factors Diabetes | 31 participants |
| Smoking-related concurrent illnesses and cardiovascular risk factors Epilepsy | 9 participants |
| Smoking-related concurrent illnesses and cardiovascular risk factors Hypertension | 110 participants |
| Smoking-related concurrent illnesses and cardiovascular risk factors Lung cancer | 10 participants |
| Smoking-related concurrent illnesses and cardiovascular risk factors Psychiatric disorders (excluding depression) | 18 participants |
| Smoking-related concurrent illnesses and cardiovascular risk factors Raised cholesterol | 114 participants |
| Source of reimbursement Private insurance | 2 participants |
| Source of reimbursement Public insurance | 214 participants |
| Source of reimbursement Self-payment | 353 participants |
| Total score on the Fagerstrom Test for Nicotine Dependence | 6.1 scores on a scale |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 93 / 551 |
| serious Total, serious adverse events | 7 / 551 |
Outcome results
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.
Time frame: Baseline through Week 12 or Week 24
Population: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Varenicline | Number of Participants With Non-serious Adverse Events (AEs) or Serious Adverse Events (SAEs) | Non-serious AEs | 131 participants |
| Varenicline | Number of Participants With Non-serious Adverse Events (AEs) or Serious Adverse Events (SAEs) | SAEs | 7 participants |
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)
Time frame: Week 7 and Week 13 or 14 (Week 13/14)
Population: All subjects population in Belgium; n=number of participants with analyzable data at observation.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Varenicline | Minnesota Nicotine Withdrawal Scale (MNWS) Subscale Scores for Participants in Belgium | Week 7: Negative affect domain (n=137) | 0.7 scores on a scale | Standard Deviation 0.7 |
| Varenicline | Minnesota Nicotine Withdrawal Scale (MNWS) Subscale Scores for Participants in Belgium | Week 13/14: Negative affect domain (n=137) | 0.6 scores on a scale | Standard Deviation 0.7 |
| Varenicline | Minnesota Nicotine Withdrawal Scale (MNWS) Subscale Scores for Participants in Belgium | Week 7: Insomnia domain (n=137) | 0.8 scores on a scale | Standard Deviation 1 |
| Varenicline | Minnesota Nicotine Withdrawal Scale (MNWS) Subscale Scores for Participants in Belgium | Week 13/14: Insomnia domain (n=137) | 0.5 scores on a scale | Standard Deviation 0.8 |
| Varenicline | Minnesota Nicotine Withdrawal Scale (MNWS) Subscale Scores for Participants in Belgium | Week 7: Urge to smoke (n=137) | 1.1 scores on a scale | Standard Deviation 1 |
| Varenicline | Minnesota Nicotine Withdrawal Scale (MNWS) Subscale Scores for Participants in Belgium | Week 13/14: Urge to smoke (n=137) | 0.8 scores on a scale | Standard Deviation 0.9 |
| Varenicline | Minnesota Nicotine Withdrawal Scale (MNWS) Subscale Scores for Participants in Belgium | Week 7: Restlessness (n=137) | 0.8 scores on a scale | Standard Deviation 1 |
| Varenicline | Minnesota Nicotine Withdrawal Scale (MNWS) Subscale Scores for Participants in Belgium | Week 13/14: Restlessness (n=137) | 0.6 scores on a scale | Standard Deviation 0.9 |
| Varenicline | Minnesota Nicotine Withdrawal Scale (MNWS) Subscale Scores for Participants in Belgium | Week 7: Increased appetite (n=134) | 1.1 scores on a scale | Standard Deviation 1.2 |
| Varenicline | Minnesota Nicotine Withdrawal Scale (MNWS) Subscale Scores for Participants in Belgium | Week 13/14: Increased appetite (n=134) | 0.9 scores on a scale | Standard Deviation 1.1 |
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
Time frame: Week 12
Population: All-subjects population
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Varenicline | Number of Participants for Whom a Maintenance Period of Varenicline Was Prescribed at the End of Week 12 | 60 participants |
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?)
Time frame: Week 12 and Week 24
Population: All-subjects population in Belgium
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Varenicline | Number of Participants in Belgium Whose Smoking Status Was Known at the End of 12 Weeks and 24 Weeks | Week 12 Responders | 138 participants |
| Varenicline | Number of Participants in Belgium Whose Smoking Status Was Known at the End of 12 Weeks and 24 Weeks | Week 12 Non-responders | 41 participants |
| Varenicline | Number of Participants in Belgium Whose Smoking Status Was Known at the End of 12 Weeks and 24 Weeks | Week 24 Responders | 103 participants |
| Varenicline | Number of Participants in Belgium Whose Smoking Status Was Known at the End of 12 Weeks and 24 Weeks | Week 24 Non-responders | 34 participants |
Secondary
Number of Participants Who Received Varenicline, by Duration of Treatment in Days
Time frame: Baseline through Week 12 or Week 24
Population: All-subjects population; Week 24 if a maintenance period was prescribed.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Varenicline | Number of Participants Who Received Varenicline, by Duration of Treatment in Days | <=1 day | 3 participants |
| Varenicline | Number of Participants Who Received Varenicline, by Duration of Treatment in Days | 2-7 days | 8 participants |
| Varenicline | Number of Participants Who Received Varenicline, by Duration of Treatment in Days | 8-14 days | 19 participants |
| Varenicline | Number of Participants Who Received Varenicline, by Duration of Treatment in Days | 15-28 days | 48 participants |
| Varenicline | Number of Participants Who Received Varenicline, by Duration of Treatment in Days | 29-60 days | 85 participants |
| Varenicline | Number of Participants Who Received Varenicline, by Duration of Treatment in Days | 61-90 days | 280 participants |
| Varenicline | Number of Participants Who Received Varenicline, by Duration of Treatment in Days | >=91 days | 108 participants |
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.)
Time frame: Week 12
Population: All-subjects population; n=number of participants with analyzable data at observation (responded to the question at the last study visit).
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Varenicline | Number of Participants Who Registered With LifeREWARDS On-line Behavioral Support Program | Belgium (n=194) | 65 participants |
| Varenicline | Number of Participants Who Registered With LifeREWARDS On-line Behavioral Support Program | Greece (n=98) | 0 participants |
| Varenicline | Number of Participants Who Registered With LifeREWARDS On-line Behavioral Support Program | Hungary (n=107) | 3 participants |
| Varenicline | Number of Participants Who Registered With LifeREWARDS On-line Behavioral Support Program | Slovenia (n=15) | 2 participants |
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?)
Time frame: Week 12
Population: All-subjects population
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Varenicline | Number of Participants Whose Smoking Status Was Known at the End of 12 Weeks | Responders | 356 participants |
| Varenicline | Number of Participants Whose Smoking Status Was Known at the End of 12 Weeks | Non-responders | 135 participants |
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.
Time frame: Weeks 3, 4, 5, 6, 7, 8, 9, 10, and 11
Population: All-subjects population
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Varenicline | Number of Participants With Smoking Cessation Assessments at Weekly Intervals From Week 3 Through Week 11 | Week 3 | 105 participants |
| Varenicline | Number of Participants With Smoking Cessation Assessments at Weekly Intervals From Week 3 Through Week 11 | Week 4 | 129 participants |
| Varenicline | Number of Participants With Smoking Cessation Assessments at Weekly Intervals From Week 3 Through Week 11 | Week 5 | 84 participants |
| Varenicline | Number of Participants With Smoking Cessation Assessments at Weekly Intervals From Week 3 Through Week 11 | Week 6 | 65 participants |
| Varenicline | Number of Participants With Smoking Cessation Assessments at Weekly Intervals From Week 3 Through Week 11 | Week 7 | 50 participants |
| Varenicline | Number of Participants With Smoking Cessation Assessments at Weekly Intervals From Week 3 Through Week 11 | Week 8 | 45 participants |
| Varenicline | Number of Participants With Smoking Cessation Assessments at Weekly Intervals From Week 3 Through Week 11 | Week 9 | 38 participants |
| Varenicline | Number of Participants With Smoking Cessation Assessments at Weekly Intervals From Week 3 Through Week 11 | Week 10 | 18 participants |
| Varenicline | Number of Participants With Smoking Cessation Assessments at Weekly Intervals From Week 3 Through Week 11 | Week 11 | 23 participants |
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?
Time frame: Week 12
Population: All-subjects population
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Varenicline | Number of Treatment Responders at Week 12 | 356 participants |
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.
Time frame: Weeks 3, 4, 5, 6, 7, 8, 9, 10, and 11
Population: All-subjects population; n=number of participants in the All-subjects population with analyzable data (responders and non-responders) who were assessed for smoking cessation at the time point (per local clinical practice) .
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Varenicline | Number of Treatment Responders at Weekly Intervals From Week 3 Through Week 11 | Week 3 (n=105) | 65 participants |
| Varenicline | Number of Treatment Responders at Weekly Intervals From Week 3 Through Week 11 | Week 4 (n=129) | 89 participants |
| Varenicline | Number of Treatment Responders at Weekly Intervals From Week 3 Through Week 11 | Week 5 (n=84) | 62 participants |
| Varenicline | Number of Treatment Responders at Weekly Intervals From Week 3 Through Week 11 | Week 6 (n=65) | 50 participants |
| Varenicline | Number of Treatment Responders at Weekly Intervals From Week 3 Through Week 11 | Week 7 (n=50) | 43 participants |
| Varenicline | Number of Treatment Responders at Weekly Intervals From Week 3 Through Week 11 | Week 8 (n=45) | 35 participants |
| Varenicline | Number of Treatment Responders at Weekly Intervals From Week 3 Through Week 11 | Week 9 (n=38) | 28 participants |
| Varenicline | Number of Treatment Responders at Weekly Intervals From Week 3 Through Week 11 | Week 10 (n=18) | 11 participants |
| Varenicline | Number of Treatment Responders at Weekly Intervals From Week 3 Through Week 11 | Week 11 (n=23) | 19 participants |
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?
Time frame: Week 12 and Week 24
Population: All-subjects population in Belgium
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Varenicline | Number of Treatment Responders in Belgium at Week 12 and at Week 24 | Week 12 | 138 participants |
| Varenicline | Number of Treatment Responders in Belgium at Week 12 and at Week 24 | Week 24 | 103 participants |