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Varenicline Observational Investigation In The Cessation of Smoking (CHOICES)

This study has been completed.
Sponsor:
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00669240
First received: April 25, 2008
Last updated: August 2, 2010
Last verified: August 2010
History of Changes
Results First Received: June 7, 2010  
Study Type: Observational
Study Design: Observational Model: Case-Only;   Time Perspective: Prospective
Condition: Smoking Cessation
Intervention: Drug: Varenicline

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
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.

Participant Flow:   Overall Study
    Varenicline  
STARTED     567  
Assigned to Treatment     566  
Received Treatment     551  
COMPLETED     402  
NOT COMPLETED     165  
Lack of Efficacy                 33  
Withdrawal by Subject                 42  
Lost to Follow-up                 34  
Adverse Event                 21  
Unspecified                 19  
Enrolled but not treated                 15  
Enrolled but no dosing record                 1  



  Baseline Characteristics
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Reporting Groups
  Description
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.

Baseline Measures
    Varenicline  
Number of Participants  
[units: participants]
 		  551  
Age, Customized  
[units: participants]
 		 
<55 years     415  
>=55 years and <=65 years     107  
>65 years     26  
Unspecified     3  
Gender, Customized  
[units: participants]
 		 
Male     295  
Female     248  
Unspecified     8  
Number of years participants smoked  
[units: years]
Mean ( Full Range ) 		  27.0  
  ( 2.0 to 60.0 )  
Average number of cigarettes participants smoked per day  
[units: cigarettes per day]
Mean ( Full Range ) 		  25.3  
  ( 5.0 to 100.0 )  
Number of participants with quit smoking history [1]
[units: participants]
 		  426  
Total score on the Fagerstrom Test for Nicotine Dependence [2]
[units: scores on a scale]
Mean ( Full Range ) 		  6.1  
  ( 0.0 to 10.0 )  
Reasons for quitting smoking [3]
[units: participants]
 		 
Family / friends     255  
Health reasons     495  
Money / cost     159  
Body image / appearance     84  
Smoking ban in public places     35  
Smoking-related concurrent illnesses and cardiovascular risk factors [4]
[units: 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  
Source of reimbursement [5]
[units: participants]
 		 
Public insurance     214  
Private insurance     2  
Self-payment     353  
[1] Number of participants who provided at least one reason for prior relapse (= number of participants with at least one prior quit smoking attempt)
[2] 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.
[3] Each participant was asked to supply the top 2 reasons for giving up smoking this time; not all participants supplied 2 reasons.
[4] 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.
[5] 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.



  Outcome Measures
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1.  Primary:   Number of Participants With Non-serious Adverse Events (AEs) or Serious Adverse Events (SAEs)   [ Time Frame: Baseline through Week 12 or Week 24 ]
  Show Outcome Measure 1

2.  Secondary:   Number of Participants Whose Smoking Status Was Known at the End of 12 Weeks   [ Time Frame: Week 12 ]
  Show Outcome Measure 2

3.  Secondary:   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 ]
  Show Outcome Measure 3

4.  Secondary:   Number of Treatment Responders at Week 12   [ Time Frame: Week 12 ]
  Show Outcome Measure 4

5.  Secondary:   Number of Treatment Responders in Belgium at Week 12 and at Week 24   [ Time Frame: Week 12 and Week 24 ]
  Hide Outcome Measure 5

Measure Type Secondary
Measure Title Number of Treatment Responders in Belgium at Week 12 and at Week 24
Measure 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  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
All-subjects population in Belgium

Reporting Groups
  Description
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.

Measured Values
    Varenicline  
Number of Participants Analyzed  
[units: participants]
 		  226  
Number of Treatment Responders in Belgium at Week 12 and at Week 24  
[units: participants]
 		 
Week 12     138  
Week 24     103  

No statistical analysis provided for Number of Treatment Responders in Belgium at Week 12 and at Week 24



6.  Secondary:   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 ]
  Show Outcome Measure 6

7.  Secondary:   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 ]
  Show Outcome Measure 7

8.  Secondary:   Number of Participants for Whom a Maintenance Period of Varenicline Was Prescribed at the End of Week 12   [ Time Frame: Week 12 ]
  Show Outcome Measure 8

9.  Secondary:   Number of Participants Who Received Varenicline, by Duration of Treatment in Days   [ Time Frame: Baseline through Week 12 or Week 24 ]
  Show Outcome Measure 9

10.  Secondary:   Number of Participants Who Registered With LifeREWARDS On-line Behavioral Support Program   [ Time Frame: Week 12 ]
  Show Outcome Measure 10

11.  Secondary:   Minnesota Nicotine Withdrawal Scale (MNWS) Subscale Scores for Participants in Belgium   [ Time Frame: Week 7 and Week 13 or 14 (Week 13/14) ]
  Show Outcome Measure 11


  Serious Adverse Events
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  Other Adverse Events
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  More Information
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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.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Limitations and Caveats
Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.  


Results Point of Contact:  
Name/Title: Pfizer ClinicalTrials.gov Call Center
Organization: Pfizer, Inc.
phone: 1-800-718-1021
e-mail: ClinicalTrials.gov_Inquiries@pfizer.com


No publications provided by Pfizer

Publications automatically indexed to this study:


Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer, Inc.
ClinicalTrials.gov Identifier: NCT00669240     History of Changes
Other Study ID Numbers: A3051085
Study First Received: April 25, 2008
Results First Received: June 7, 2010
Last Updated: August 2, 2010
Health Authority: Greece: Ethics Committee