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Varenicline Observational Investigation In The Cessation of Smoking (CHOICES)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00669240
Recruitment Status : Completed
First Posted : April 30, 2008
Results First Posted : July 7, 2010
Last Update Posted : July 23, 2015
Sponsor:
Information provided by (Responsible Party):
Pfizer

Study Type Observational
Study Design Observational Model: Case-Only;   Time Perspective: Prospective
Condition Smoking Cessation
Intervention Drug: Varenicline
Enrollment 567
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Varenicline
Hide Arm/Group Description 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.
Period Title: Overall Study
Started 567
Assigned to Treatment 566
Received Treatment 551
Completed 402
Not Completed 165
Reason Not Completed
Lack of Efficacy             33
Withdrawal by Subject             42
Lost to Follow-up             34
Adverse Event             21
Other             19
Enrolled but not treated             15
Enrolled but no dosing record             1
Arm/Group Title Varenicline
Hide Arm/Group Description 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.
Overall Number of Baseline Participants 551
Hide Baseline Analysis Population Description
[Not Specified]
Age, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 551 participants
<55 years 415
>=55 years and <=65 years 107
>65 years 26
Unspecified 3
Sex/Gender, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 551 participants
Male 295
Female 248
Unspecified 8
Number of years participants smoked  
Mean (Full Range)
Unit of measure:  Years
Number Analyzed 551 participants
27.0
(2.0 to 60.0)
Average number of cigarettes participants smoked per day  
Mean (Full Range)
Unit of measure:  Cigarettes per day
Number Analyzed 551 participants
25.3
(5.0 to 100.0)
Number of participants with quit smoking history   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 551 participants
426
[1]
Measure Description: Number of participants who provided at least one reason for prior relapse (= number of participants with at least one prior quit smoking attempt)
Total score on the Fagerstrom Test for Nicotine Dependence   [1] 
Mean (Full Range)
Unit of measure:  Scores on a scale
Number Analyzed 551 participants
6.1
(0.0 to 10.0)
[1]
Measure Description: The self-administered Fagerstrom Test for Nicotine Dependence questionnaire assesses level of nicotine dependence. Total score: 0-2=very low dependence; 3-4=low dependence; 5=medium dependence; 6-7=high dependence; 8-10=very high dependence.
Reasons for quitting smoking   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 551 participants
Family / friends 255
Health reasons 495
Money / cost 159
Body image / appearance 84
Smoking ban in public places 35
[1]
Measure Description: Each participant was asked to supply the top 2 reasons for giving up smoking this time; not all participants supplied 2 reasons.
Smoking-related concurrent illnesses and cardiovascular risk factors   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 551 participants
Diabetes 31
Raised cholesterol 114
Hypertension 110
Cardiovascular disease 54
Chronic obstructive pulmonary disease (COPD) 100
Lung cancer 10
Epilepsy 9
Psychiatric disorders (excluding depression) 18
Depression 52
[1]
Measure Description: Some participants may have had more than 1 condition and may be represented in more than 1 category, and some participants may not have had any condition.
Source of reimbursement   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 551 participants
Public insurance 214
Private insurance 2
Self-payment 353
[1]
Measure Description: Source of funding for the cost of varenicline treatment. Some participants listed more than one source of funding and are represented in more than 1 category.
1.Primary Outcome
Title Number of Participants With Non-serious Adverse Events (AEs) or Serious Adverse Events (SAEs)
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
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/Group Title Varenicline
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 551
Measure Type: Number
Unit of Measure: participants
Non-serious AEs 131
SAEs 7
2.Secondary Outcome
Title Number of Participants Whose Smoking Status Was Known at the End of 12 Weeks
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
All-subjects population
Arm/Group Title Varenicline
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 551
Measure Type: Number
Unit of Measure: participants
Responders 356
Non-responders 135
3.Secondary Outcome
Title Number of Participants in Belgium Whose Smoking Status Was Known at the End of 12 Weeks and 24 Weeks
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
All-subjects population in Belgium
Arm/Group Title Varenicline
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 226
Measure Type: Number
Unit of Measure: participants
Week 12 Responders 138
Week 12 Non-responders 41
Week 24 Responders 103
Week 24 Non-responders 34
4.Secondary Outcome
Title Number of Treatment Responders at Week 12
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
All-subjects population
Arm/Group Title Varenicline
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 551
Measure Type: Number
Unit of Measure: participants
356
5.Secondary Outcome
Title Number of Treatment Responders in Belgium at Week 12 and at Week 24
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
All-subjects population in Belgium
Arm/Group Title Varenicline
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 226
Measure Type: Number
Unit of Measure: participants
Week 12 138
Week 24 103
6.Secondary Outcome
Title Number of Participants With Smoking Cessation Assessments at Weekly Intervals From Week 3 Through Week 11
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
All-subjects population
Arm/Group Title Varenicline
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 551
Measure Type: Number
Unit of Measure: participants
Week 3 105
Week 4 129
Week 5 84
Week 6 65
Week 7 50
Week 8 45
Week 9 38
Week 10 18
Week 11 23
7.Secondary Outcome
Title Number of Treatment Responders at Weekly Intervals From Week 3 Through Week 11
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
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/Group Title Varenicline
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 551
Measure Type: Number
Unit of Measure: participants
Week 3 (n=105) 65
Week 4 (n=129) 89
Week 5 (n=84) 62
Week 6 (n=65) 50
Week 7 (n=50) 43
Week 8 (n=45) 35
Week 9 (n=38) 28
Week 10 (n=18) 11
Week 11 (n=23) 19
8.Secondary Outcome
Title Number of Participants for Whom a Maintenance Period of Varenicline Was Prescribed at the End of Week 12
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
All-subjects population
Arm/Group Title Varenicline
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 551
Measure Type: Number
Unit of Measure: participants
60
9.Secondary Outcome
Title Number of Participants Who Received Varenicline, by Duration of Treatment in Days
Hide Description [Not Specified]
Time Frame Baseline through Week 12 or Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
All-subjects population; Week 24 if a maintenance period was prescribed.
Arm/Group Title Varenicline
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 551
Measure Type: Number
Unit of Measure: participants
<=1 day 3
2-7 days 8
8-14 days 19
15-28 days 48
29-60 days 85
61-90 days 280
>=91 days 108
10.Secondary Outcome
Title Number of Participants Who Registered With LifeREWARDS On-line Behavioral Support Program
Hide Description Number of participants who answered 'yes' to the question "Did you register with LifeREWARDS?" (LifeREWARDS not available in Greece.)
Time Frame Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
All-subjects population; n=number of participants with analyzable data at observation (responded to the question at the last study visit).
Arm/Group Title Varenicline
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 551
Measure Type: Number
Unit of Measure: participants
Belgium (n=194) 65
Greece (n=98) 0
Hungary (n=107) 3
Slovenia (n=15) 2
11.Secondary Outcome
Title Minnesota Nicotine Withdrawal Scale (MNWS) Subscale Scores for Participants in Belgium
Hide Description 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)
Hide Outcome Measure Data
Hide Analysis Population Description
All subjects population in Belgium; n=number of participants with analyzable data at observation.
Arm/Group Title Varenicline
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 226
Mean (Standard Deviation)
Unit of Measure: scores on a scale
Week 7: Negative affect domain (n=137) 0.7  (0.7)
Week 13/14: Negative affect domain (n=137) 0.6  (0.7)
Week 7: Insomnia domain (n=137) 0.8  (1.0)
Week 13/14: Insomnia domain (n=137) 0.5  (0.8)
Week 7: Urge to smoke (n=137) 1.1  (1.0)
Week 13/14: Urge to smoke (n=137) 0.8  (0.9)
Week 7: Restlessness (n=137) 0.8  (1.0)
Week 13/14: Restlessness (n=137) 0.6  (0.9)
Week 7: Increased appetite (n=134) 1.1  (1.2)
Week 13/14: Increased appetite (n=134) 0.9  (1.1)
Time Frame 12 weeks and up to 24 weeks for participants presribed maintenance period
Adverse Event Reporting Description The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
 
Arm/Group Title Varenicline
Hide Arm/Group Description 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.
All-Cause Mortality
Varenicline
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Varenicline
Affected / at Risk (%)
Total   7/551 (1.27%) 
Cardiac disorders   
Cardiovascular disorder  1  1/551 (0.18%) 
Palpitations  1  1/551 (0.18%) 
Gastrointestinal disorders   
Gastrointestinal disorder  1  1/551 (0.18%) 
Infections and infestations   
Urinary tract infection  1  1/551 (0.18%) 
Musculoskeletal and connective tissue disorders   
Intervertebral disc protrusion  1  1/551 (0.18%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)   
Metastases to central nervous system  1  1/551 (0.18%) 
Psychiatric disorders   
Mental disorder  1  1/551 (0.18%) 
Respiratory, thoracic and mediastinal disorders   
Chronic obstructive pulmonary disease  1  1/551 (0.18%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA v12.1
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 1%
Varenicline
Affected / at Risk (%)
Total   93/551 (16.88%) 
Gastrointestinal disorders   
Abdominal pain upper  1  9/551 (1.63%) 
Gastritis  1  6/551 (1.09%) 
Nausea  1  49/551 (8.89%) 
General disorders   
Fatigue  1  7/551 (1.27%) 
Psychiatric disorders   
Abnormal dreams  1  10/551 (1.81%) 
Insomnia  1  16/551 (2.90%) 
Sleep disorder  1  12/551 (2.18%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA v12.1
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
Results Point of Contact
Name/Title: Pfizer ClinicalTrials.gov Call Center
Organization: Pfizer, Inc.
Phone: 1-800-718-1021
Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT00669240     History of Changes
Other Study ID Numbers: A3051085
First Submitted: April 25, 2008
First Posted: April 30, 2008
Results First Submitted: June 7, 2010
Results First Posted: July 7, 2010
Last Update Posted: July 23, 2015