"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
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.
|Study Design:||Observational Model: Cohort
Time Perspective: Prospective
|Official Title:||"VIBRATIONS": Varenicline In Patients Ambitioned To Terminate Smoking - A Non-Interventional Study|
- Percentage of Participants Who Abstained From Smoking at Week 12 [ Time Frame: Week 12 ] [ Designated as safety issue: No ]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.
- Level of Nicotine Dependence Measured by the Fagerstrom Test [ Time Frame: Baseline ] [ Designated as safety issue: No ]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).
|Study Start Date:||May 2010|
|Study Completion Date:||March 2011|
|Primary Completion Date:||March 2011 (Final data collection date for primary outcome measure)|
|Single group prospective treatment cohort (varenicline)||
varenicline tablets prescribed as per local German SmPC for 12 weeks duration
Sampling Method Details: Non-interventional study: subjects to be selected according to the usual clinical practice of their physician.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01104636
|Study Director:||Pfizer CT.gov Call Center||Pfizer|