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Smoking Cessation Medications: Efficacy, Mechanisms and Algorithms

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:
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
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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.
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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
Total Total of all reporting groups

Baseline Measures
   Nicotine Patch   Nicotine Lozenge   Nicotine Patch + Lozenge   Bupropion   Bupropion + Nicotine Lozenge   Placebo Control   Total 
Overall Participants Analyzed 
[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 ]


  Serious Adverse Events


  Other Adverse Events
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Time Frame 6 months
Additional Description collection of data at all visits and phone contacts

Frequency Threshold
Threshold above which other adverse events are reported   5  

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

Other Adverse Events
    Nicotine Patch   Nicotine Lozenge   Nicotine Patch + Lozenge   Bupropion   Bupropion + Nicotine Lozenge   Placebo Control
Total, other (not including serious) adverse events             
# participants affected / at risk   207/262 (79.01%)   214/260 (82.31%)   227/267 (85.02%)   195/264 (73.86%)   217/262 (82.82%)   129/189 (68.25%) 
Gastrointestinal disorders             
flatulence †             
# participants affected / at risk   0/262 (0.00%)   10/260 (3.85%)   9/267 (3.37%)   0/264 (0.00%)   16/262 (6.11%)   4/189 (2.12%) 
# events   0   10   9   0   16   4 
heartburn †             
# participants affected / at risk   2/262 (0.76%)   31/260 (11.92%)   22/267 (8.24%)   2/264 (0.76%)   21/262 (8.02%)   1/189 (0.53%) 
# events   2   31   22   2   21   1 
General disorders             
dizziness †             
# participants affected / at risk   7/262 (2.67%)   5/260 (1.92%)   9/267 (3.37%)   6/264 (2.27%)   15/262 (5.73%)   6/189 (3.17%) 
# events   7   5   9   6   15   6 
Dry mouth †             
# participants affected / at risk   1/262 (0.38%)   0/260 (0.00%)   2/267 (0.75%)   20/264 (7.58%)   25/262 (9.54%)   3/189 (1.59%) 
# events   1   0   2   20   25   3 
headache †             
# participants affected / at risk   26/262 (9.92%)   29/260 (11.15%)   34/267 (12.73%)   23/264 (8.71%)   30/262 (11.45%)   24/189 (12.70%) 
# events   26   29   34   23   30   24 
hiccups †             
# participants affected / at risk   0/262 (0.00%)   35/260 (13.46%)   22/267 (8.24%)   0/264 (0.00%)   7/262 (2.67%)   1/189 (0.53%) 
# events   0   35   22   0   7   1 
sleep disturbance †             
# participants affected / at risk   67/262 (25.57%)   18/260 (6.92%)   63/267 (23.60%)   88/264 (33.33%)   69/262 (26.34%)   20/189 (10.58%) 
# events   67   18   63   88   69   20 
throat irritation †             
# participants affected / at risk   7/262 (2.67%)   18/260 (6.92%)   21/267 (7.87%)   6/264 (2.27%)   16/262 (6.11%)   5/189 (2.65%) 
# events   7   18   21   6   16   5 
Infections and infestations             
cold †             
# participants affected / at risk   92/262 (35.11%)   102/260 (39.23%)   88/267 (32.96%)   74/264 (28.03%)   65/262 (24.81%)   57/189 (30.16%) 
# events   92   102   88   74   65   57 
cough †             
# participants affected / at risk   16/262 (6.11%)   13/260 (5.00%)   13/267 (4.87%)   9/264 (3.41%)   8/262 (3.05%)   7/189 (3.70%) 
# events   16   13   13   9   8   7 
flu †             
# participants affected / at risk   9/262 (3.44%)   16/260 (6.15%)   15/267 (5.62%)   7/264 (2.65%)   22/262 (8.40%)   10/189 (5.29%) 
# events   9   16   15   7   22   10 
nausea †             
# participants affected / at risk   25/262 (9.54%)   44/260 (16.92%)   55/267 (20.60%)   20/264 (7.58%)   33/262 (12.60%)   16/189 (8.47%) 
# events   25   44   55   20   33   16 
Skin and subcutaneous tissue disorders             
skin irritation †             
# participants affected / at risk   85/262 (32.44%)   3/260 (1.15%)   63/267 (23.60%)   12/264 (4.55%)   15/262 (5.73%)   8/189 (4.23%) 
# events   85   3   63   12   15   8 
Events were collected by systematic assessment



  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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