"VIBRATIONS": Varenicline In Patients Ambitioned To Terminate Smoking - A Non-Interventional Study
Overview
- Phase
- Not Applicable
- Intervention
- Varenicline
- Conditions
- Smoking Cessation
- Sponsor
- Pfizer
- Enrollment
- 1177
- Primary Endpoint
- Percentage of Participants Who Abstained From Smoking at Week 12
- Status
- Completed
- Last Updated
- 14 years ago
Overview
Brief Summary
The aim of this study is to determine the success rates for stopping smoking with varenicline in Germany. The main measure of success will be continuous abstinence from smoking (not a single puff) in the last week of the standard 12 week treatment period. Additional information will be gathered regarding prescribing practices in Germany, smoking history, reasons why smokers quit smoking and re-start smoking, smoking related illnesses and the tolerability of varenicline.
Detailed Description
Sampling Method Details: Non-interventional study: subjects to be selected according to the usual clinical practice of their physician.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Legal adult age
- •Regular smoker, with main tobacco product smoked being cigarettes, and willing and motivated to stop smoking
- •Evidence of a personally signed and dated Informed Consent document.
Exclusion Criteria
- •Any subjects considered unsuitable according to the Summary of product characteristics (SmPC)
Arms & Interventions
Single group prospective treatment cohort (varenicline)
Intervention: Varenicline
Outcomes
Primary Outcomes
Percentage of Participants Who Abstained From Smoking at Week 12
Time Frame: Week 12
The use of nicotine was recorded using Nicotine Use Inventory (NUI) to determine the participants who abstained from smoking for the previous 7 days. A responder for the 7-day point prevalence was defined as those with 'no' answers to the following two questions: Did the participant smoke any cigarettes (even a puff) in the last 7 days; and did participant use any other tobacco products (example pipe, cigars, snuff, chewing tobacco) in the last 7 days.
Secondary Outcomes
- Level of Nicotine Dependence Measured by the Fagerstrom Test(Baseline)