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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
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Participants were 1346 smokers recruited in 12 Aurora Health Care primary care clinics in eastern Wisconsin from October 2005 through May 2007.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Primary inclusion criteria included (1) 18 years or older; (2) 10 or more cigarettes per day (CPD) for the past 6 months; (3) motivated to quit smoking; and (4) if female, willing to use an acceptable contraception while using the study medication.

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.

Participant Flow:   Overall Study
    Patch     Nicotine Lozenge     Bupropion     Patch + Lozenge     Buproion + Lozenge  
STARTED     282     261     256     279     268  
COMPLETED     250     233     222     262     248  
NOT COMPLETED     32     28     34     17     20  
Death                 4                 1                 2                 1                 1  
Withdrawal by Subject                 28                 27                 32                 16                 19  



  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.


  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Stevens Smith, PhD
Organization: UW-Center for Tobacco Research and Intervention
phone: 608-262-7563
e-mail: sss@ctri.medicine.wisc.edu


No publications provided by University of Wisconsin, Madison

Publications automatically indexed to this study:

Responsible Party: University of Wisconsin, Madison
ClinicalTrials.gov Identifier: NCT00296647     History of Changes
Obsolete Identifiers: NCT00106873
Other Study ID Numbers: P50DA19706-2, P50DA019706
Study First Received: February 24, 2006
Results First Received: October 21, 2011
Last Updated: October 21, 2011
Health Authority: United States: Federal Government