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Smoking Cessation Intervention: Effectiveness in Primary Care

This study has been completed.
Sponsor:
Collaborator:
National Institute on Drug Abuse (NIDA)
Information provided by (Responsible Party):
University of Wisconsin, Madison
ClinicalTrials.gov Identifier:
NCT00296647
First received: February 24, 2006
Last updated: October 9, 2015
Last verified: October 2015
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
  Hide Participant Flow

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


  Outcome Measures

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


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
  Hide Limitations and Caveats

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