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
  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
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

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
  Hide Baseline Characteristics

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
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
Total Total of all reporting groups

Baseline Measures
    Nicotine Patch     Nicotine Lozenge     Nicotine Patch + Lozenge     Bupropion     Bupropion + Nicotine Lozenge     Placebo Control     Total  
Number of Participants  
[units: participants]
  262     260     267     264     262     189     1504  
Age  
[units: participants]
             
<=18 years     0     0     0     0     0     0     0  
Between 18 and 65 years     252     256     262     256     256     179     1461  
>=65 years     10     4     5     8     6     10     43  
Age  
[units: years]
Mean ± Standard Deviation
  44.9  ± 11.6     45.3  ± 10.4     44.2  ± 11.1     43.9  ± 11.7     45.3  ± 10.4     43.1  ± 11.4     44.7  ± 11.1  
Gender  
[units: participants]
             
Female     153     151     153     154     154     111     876  
Male     109     109     114     110     108     78     628  
Region of Enrollment  
[units: participants]
             
United States     262     260     267     264     262     189     1504  



  Outcome Measures

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

Measure Type Primary
Measure Title 7-day Point Prevalence of Smoking, Biochemically (Exhaled CO) Confirmed
Measure Description Smoking status was assessed both as 7-day point-prevalence abstinence (“Have you smoked at all, even a puff, in the last 7 days?”) and continuous abstinence (smoking at all since the target quit day), using a smoking calendar and the timeline follow-back method. All participants’ self-reports of smoking status during study visits were confirmed by an expired carbon monoxide level of less than 10 ppm measured using a Micro-3 Smokerlyzer (Bedfont Scientific, Williamsburg, Virginia).
Time Frame 6 months post quit date  
Safety Issue No  

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
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

Measured Values
    Nicotine Patch     Nicotine Lozenge     Nicotine Patch + Lozenge     Bupropion     Bupropion + Nicotine Lozenge     Placebo Control  
Number of Participants Analyzed  
[units: participants]
  262     260     267     264     262     189  
7-day Point Prevalence of Smoking, Biochemically (Exhaled CO) Confirmed  
[units: participants with<10 ppm exhaled CO]
  90     87     107     84     87     42  

No statistical analysis provided for 7-day Point Prevalence of Smoking, Biochemically (Exhaled CO) Confirmed




  Serious Adverse Events


  Other Adverse Events


  More Information
  Hide More Information

Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


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
No text entered.  


Results Point of Contact:  
Name/Title: Piper, Megan E
Organization: University of Wisconsin
phone: 608-265-5472
e-mail: mep@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: NCT00332644     History of Changes
Obsolete Identifiers: NCT00109447
Other Study ID Numbers: P50DA19706-1, P50DA019706
Study First Received: June 1, 2006
Results First Received: October 21, 2011
Last Updated: October 21, 2011
Health Authority: United States: Federal Government