Smoking Cessation Intervention: Effectiveness in Primary Care

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
University of Wisconsin, Madison
ClinicalTrials.gov Identifier:
NCT00296647
First received: February 24, 2006
Last updated: October 21, 2011
Last verified: October 2011
Results First Received: October 21, 2011  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Tobacco Dependence
Interventions: Drug: nicotine patch
Drug: nicotine lozenge
Drug: bupropion
Drug: patch + lozenge
Drug: bupropion + lozenge

  Participant Flow


  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Patch No text entered.
Nicotine Lozenge No text entered.
Bupropion No text entered.
Patch + Lozenge No text entered.
Buproion + Lozenge No text entered.
Total Total of all reporting groups

Baseline Measures
    Patch     Nicotine Lozenge     Bupropion     Patch + Lozenge     Buproion + Lozenge     Total  
Number of Participants  
[units: participants]
  282     261     256     279     268     1346  
Age  
[units: years]
Mean ± Standard Deviation
  44.5  ± 12.4     42.9  ± 11.7     44  ± 11.6     44.8  ± 12.4     45.4  ± 12.2     44.3  ± 12.1  
Gender  
[units: participants]
           
Female     158     142     143     158     152     753  
Male     124     119     113     121     116     593  
Region of Enrollment  
[units: participants]
           
United States     282     261     256     279     268     1346  



  Outcome Measures

1.  Primary:   6 Month Self-reported Abstinence From Smoking   [ Time Frame: 6 months ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
The present study is limited to some extent by the fact that self-reported abstinence was not biochemically confirmed. However, there is evidence that self-reported abstinence rates are generally accurate in low-contact effectiveness studies.


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