"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

NCT01104636 | Completed Results

• 1 other identifier: A3051141
• Study Type: observational
• Target: 1,177
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Smoking Cessation

Outcome Measures

Primary Outcomes (1)

• Percentage of Participants Who Abstained From Smoking at 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.

  Week 12

Secondary Outcomes (1)

• Level of Nicotine Dependence Measured by the Fagerstrom Test

  Baseline

Study Arms (1)

Single group prospective treatment cohort (varenicline)

Drug: Varenicline

Interventions

Varenicline DRUG

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

Single group prospective treatment cohort (varenicline)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult smokers who are willing and motivated to stop smoking

You may qualify if:

• 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.

You may not qualify if:

• Any subjects considered unsuitable according to the Summary of product characteristics (SmPC)

Sponsors & Collaborators

• Pfizer: lead

Related Links

• To obtain contact information for a study center near you, click here.

MeSH Terms

Conditions

Smoking Cessation

Interventions

Varenicline

Condition Hierarchy (Ancestors)

Health Behavior; Behavior

Intervention Hierarchy (Ancestors)

Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Quinoxalines

Limitations and Caveats

It is highly likely that Adverse Events were under reported for this study as it was a Non Interventional study.

Results Point of Contact

• Title: Pfizer ClinicalTrials.gov Call Center
• Organization: Pfizer, Inc.

ClinicalTrials.gov_Inquiries@pfizer.com

1-800-718-1021

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 14, 2010
• First Posted: April 15, 2010
• Study Start: May 1, 2010
• Primary Completion: March 1, 2011
• Study Completion: March 1, 2011
• Last Updated: March 2, 2012
• Results First Posted: February 24, 2012

Record last verified: 2012-03