"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 (VIBRATIONS)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01104636|
Recruitment Status : Completed
First Posted : April 15, 2010
Results First Posted : February 24, 2012
Last Update Posted : March 2, 2012
|Condition or disease||Intervention/treatment|
|Smoking Cessation||Drug: Varenicline|
|Study Type :||Observational|
|Actual Enrollment :||1177 participants|
|Official Title:||"VIBRATIONS": Varenicline In Patients Ambitioned To Terminate Smoking - A Non-Interventional Study|
|Study Start Date :||May 2010|
|Primary Completion Date :||March 2011|
|Study Completion Date :||March 2011|
|Single group prospective treatment cohort (varenicline)||
varenicline tablets prescribed as per local German SmPC for 12 weeks duration
- 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.
- Level of Nicotine Dependence Measured by the Fagerstrom Test [ Time Frame: Baseline ]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).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01104636
|Study Director:||Pfizer CT.gov Call Center||Pfizer|