"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

Smoking Cessation Clinical Trial

— VIBRATIONS  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01104636
• Other study ID #: A3051141
• Status: Completed
• Phase: N/A
• First received: April 14, 2010
• Last updated: March 1, 2012
• Start date: May 2010
• Est. completion date: March 2011

Study information

• Verified date: March 2012
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Bundesinstitut für Arzneimittel und Medizinprodukte
• Study type: Observational

Clinical Trial 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.

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1177
• Est. completion date: March 2011
• Est. primary completion date: March 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Smoking Cessation

Intervention

Drug:
• Varenicline
varenicline tablets prescribed as per local German SmPC for 12 weeks duration

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No

External Links

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