"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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT01104636
First received: April 14, 2010
Last updated: March 1, 2012
Last verified: March 2012
  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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01104636

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

Additional Information:
No publications provided

Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT01104636     History of Changes
Other Study ID Numbers: A3051141
Study First Received: April 14, 2010
Results First Received: January 17, 2012
Last Updated: March 1, 2012
Health Authority: Germany: Bundesinstitut für Arzneimittel und Medizinprodukte

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

ClinicalTrials.gov processed this record on April 23, 2014