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"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)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01104636
First Posted: April 15, 2010
Last Update Posted: March 2, 2012
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.
Information provided by (Responsible Party):
Pfizer
  Purpose
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 Intervention
Smoking Cessation Drug: Varenicline

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: "VIBRATIONS": Varenicline In Patients Ambitioned To Terminate Smoking - A Non-Interventional Study

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • 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:
  • 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).


Enrollment: 1177
Study Start Date: May 2010
Study Completion Date: March 2011
Primary Completion Date: March 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Single group prospective treatment cohort (varenicline) Drug: Varenicline
varenicline tablets prescribed as per local German SmPC for 12 weeks duration

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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
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
Criteria

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)
  Contacts and Locations
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 ClinicalTrials.gov identifier (NCT number): NCT01104636


Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT01104636     History of Changes
Other Study ID Numbers: A3051141
First Submitted: April 14, 2010
First Posted: April 15, 2010
Results First Submitted: January 17, 2012
Results First Posted: February 24, 2012
Last Update Posted: March 2, 2012
Last Verified: March 2012

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