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Completed

NCT Number: NCT00669240

Varenicline Observational Investigation In The Cessation of Smoking

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.

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Key information

Conditions

Smoking Cessation Behavior Health Behavior

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Pfizer Investigational Site, Alleur, Belgium

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About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Varenicline

Drug

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.

Other names: Champix, Chantix, CP-526,555

Primary outcomes

  1. Number of Participants With Non-serious Adverse Events (AEs) or Serious Adverse Events (SAEs)

    Time frame: 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 outcomes

  1. Number of Participants Whose Smoking Status Was Known at the End of 12 Weeks

    Time frame: 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?)

  2. 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

    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?)

  3. Number of Treatment Responders at Week 12

    Time frame: 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?

  4. Number of Treatment Responders in Belgium at Week 12 and at Week 24

    Time frame: 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?

  5. 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

    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.

  6. 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

    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.

  7. Number of Participants for Whom a Maintenance Period of Varenicline Was Prescribed at the End of Week 12

    Time frame: 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

  8. Number of Participants Who Received Varenicline, by Duration of Treatment in Days

    Time frame: Baseline through Week 12 or Week 24

  9. Number of Participants Who Registered With LifeREWARDS On-line Behavioral Support Program

    Time frame: Week 12

    Number of participants who answered 'yes' to the question "Did you register with LifeREWARDS?" (LifeREWARDS not available in Greece.)

  10. Minnesota Nicotine Withdrawal Scale (MNWS) Subscale Scores for Participants in Belgium

    Time frame: 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)

Sponsors and collaborators

Lead sponsor

Pfizer

Industry

Registry information

Official study title

Champix Observational Investigation In The Cessation of Smoking

Acronym: CHOICES

Important dates

Study start
2007
Primary completion
2009
Study completion
2009
First posted
Apr 30, 2008
Registry last updated
Jul 23, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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