"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. Identifier: NCT01104636
Recruitment Status : Completed
First Posted : April 15, 2010
Results First Posted : February 24, 2012
Last Update Posted : March 2, 2012
Information provided by (Responsible Party):

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.

Condition or disease Intervention/treatment
Smoking Cessation Drug: Varenicline

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

Study Type : Observational
Actual Enrollment : 1177 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: "VIBRATIONS": Varenicline In Patients Ambitioned To Terminate Smoking - A Non-Interventional Study
Study Start Date : May 2010
Actual Primary Completion Date : March 2011
Actual Study Completion Date : March 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Smoking

Group/Cohort Intervention/treatment
Single group prospective treatment cohort (varenicline) Drug: Varenicline
varenicline tablets prescribed as per local German SmPC for 12 weeks duration

Primary Outcome Measures :
  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 Outcome Measures :
  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).

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Adult smokers who are willing and motivated to stop smoking

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)

Information from the National Library of Medicine

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 identifier (NCT number): NCT01104636

Sponsors and Collaborators
Study Director: Pfizer Call Center Pfizer

Additional Information:
Responsible Party: Pfizer Identifier: NCT01104636     History of Changes
Other Study ID Numbers: A3051141
First Posted: April 15, 2010    Key Record Dates
Results First Posted: February 24, 2012
Last Update Posted: March 2, 2012
Last Verified: March 2012

Additional relevant MeSH terms:
Nicotinic Agonists
Cholinergic Agonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs