VIBRATIONS - A Study In Smokers Who Are Willing And Motivated To Stop Smoking With The Aid Of Varenicline Which Will Be Prescribed According To Usual Clinical Practice In Germany

Study Overview
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Brief Summary
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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
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Sampling Method Details: Non-interventional study: subjects to be selected according to the usual clinical practice of their physician.

Official Title
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VIBRATIONS: Varenicline In Patients Ambitioned To Terminate Smoking - A Non-Interventional Study

Conditions
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Smoking Cessation

Intervention / Treatment
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* Drug: Varenicline


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Single group prospective treatment cohort (varenicline)<br> | Drug: Varenicline<br>* varenicline tablets prescribed as per local German SmPC for 12 weeks duration<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Participants Who Abstained From Smoking at 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. | Week 12 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Level of Nicotine Dependence Measured by the Fagerstrom Test | Fagerstrom Test for Nicotine Dependence (FTND) was designed to provide measure of nicotine dependence related to cigarette smoking. It contains 4 yes-no and 2 multiple choice questions. Items are scored 0-3 for multiple choice items, items are summed to yield total score of 0-10 (0=minimum to 10=maximum nicotine dependence). | Baseline |