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Trial record 1 of 1 for:    NCT01104636
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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)

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

Tracking Information
First Submitted Date April 14, 2010
First Posted Date April 15, 2010
Results First Submitted Date January 17, 2012
Results First Posted Date February 24, 2012
Last Update Posted Date March 2, 2012
Study Start Date May 2010
Actual Primary Completion Date March 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: January 17, 2012)
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.
Original Primary Outcome Measures
 (submitted: April 14, 2010)
7 Day Point Prevalence Abstinence Rate at Week 12 [ Time Frame: 12 Weeks ]
Change History
Current Secondary Outcome Measures
 (submitted: January 17, 2012)
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).
Original Secondary Outcome Measures
 (submitted: April 14, 2010)
Fagerstrom Test (to assess level of nicotine dependence) [ Time Frame: Week 0 ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title "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
Official Title "VIBRATIONS": Varenicline In Patients Ambitioned To Terminate Smoking - A Non-Interventional Study
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.
Detailed Description Sampling Method Details: Non-interventional study: subjects to be selected according to the usual clinical practice of their physician.
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Adult smokers who are willing and motivated to stop smoking
Condition Smoking Cessation
Intervention Drug: Varenicline
varenicline tablets prescribed as per local German SmPC for 12 weeks duration
Study Groups/Cohorts Single group prospective treatment cohort (varenicline)
Intervention: Drug: Varenicline
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: January 17, 2012)
1177
Original Estimated Enrollment
 (submitted: April 14, 2010)
3000
Actual Study Completion Date March 2011
Actual Primary Completion Date March 2011   (Final data collection date for primary outcome measure)
Eligibility 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)
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number NCT01104636
Other Study ID Numbers A3051141
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Pfizer
Study Sponsor Pfizer
Collaborators Not Provided
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
PRS Account Pfizer
Verification Date March 2012