"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

Completed

• Conditions: Smoking Cessation
• Interventions: Drug: Varenicline

• Registration Number: NCT01104636
• Lead Sponsor: Pfizer

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.

Study Timeline

• Study First Submitted: 2010-04-14
• Study First Submitted QC: 2010-04-14
• Study First Posted: 2010-04-15
• Study Start: 2010-05
• Primary Completion: 2011-03
• Study Completion: 2011-03
• Results First Submitted: 2012-01-17
• Results First Submitted QC: 2012-01-17
• Results First Posted: 2012-02-24
• Status Verified: 2012-03
• Last Update Submitted: 2012-03-01
• Last Update Posted: 2012-03-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1177

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)

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Single group prospective treatment cohort (varenicline)	Varenicline	-

Primary Outcome Measures

Name	Time	Method
Percentage of Participants Who Abstained From Smoking at Week 12	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 Outcome Measures

Name	Time	Method
Level of Nicotine Dependence Measured by the Fagerstrom Test	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).