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Completed

NCT Number: NCT01104636

"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.

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Key information

Conditions

Smoking Cessation Behavior Health Behavior

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Varenicline

Drug

varenicline tablets prescribed as per local German SmPC for 12 weeks duration

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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).

Sponsors and collaborators

Lead sponsor

Pfizer

Industry

Registry information

Official study title

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

Acronym: VIBRATIONS

Important dates

Study start
2010
Primary completion
2011
Study completion
2011
First posted
Apr 15, 2010
Registry last updated
Mar 2, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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