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Smoking Cessation Medications: Efficacy, Mechanisms and Algorithms

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
University of Wisconsin, Madison
ClinicalTrials.gov Identifier:
NCT00332644
First received: June 1, 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: Single Group Assignment;   Masking: Double Blind (Subject, Investigator);   Primary Purpose: Treatment
Condition: Nicotine Dependence
Interventions: Drug: nicotine patch
Drug: nicotine lozenge
Drug: nicotine patch + nicotine lozenge
Drug: bupropion
Drug: bupropion + lozenge
Drug: placebo

  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
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
Nicotine Patch nicotine patch alone treatment for nicotine dependence.
Nicotine Lozenge nicotine lozenge alone treatment
Nicotine Patch + Lozenge nicotine patch + lozenge combination treatment
Bupropion bupropion alone treatment
Bupropion + Nicotine Lozenge bupropion + nicotine lozenge combination treatment
Placebo Control placebo control (no active medication) treatment

Participant Flow:   Overall Study
    Nicotine Patch     Nicotine Lozenge     Nicotine Patch + Lozenge     Bupropion     Bupropion + Nicotine Lozenge     Placebo Control  
STARTED     262     260     267     264     262     189  
COMPLETED     250     238     258     244     250     174  
NOT COMPLETED     12     22     9     20     12     15  



  Baseline Characteristics


  Outcome Measures

1.  Primary:   7-day Point Prevalence of Smoking, Biochemically (Exhaled CO) Confirmed   [ Time Frame: 6 months post quit date ]


  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
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  More Information