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

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

Serious Adverse Events
    Nicotine Patch   Nicotine Lozenge   Nicotine Patch + Lozenge   Bupropion   Bupropion + Nicotine Lozenge   Placebo Control
Total, serious adverse events             
# participants affected / at risk   5/262 (1.91%)   5/260 (1.92%)   5/267 (1.87%)   8/264 (3.03%)   6/262 (2.29%)   6/189 (3.17%) 
Cardiac disorders             
hospitalization: cardiovascular †             
# participants affected / at risk   1/262 (0.38%)   3/260 (1.15%)   2/267 (0.75%)   3/264 (1.14%)   0/262 (0.00%)   2/189 (1.06%) 
# events   1   3   2   3   0   2 
Gastrointestinal disorders             
Hopitalization: abdominal pain             
# participants affected / at risk   0/262 (0.00%)   0/260 (0.00%)   0/267 (0.00%)   1/264 (0.38%)   0/262 (0.00%)   0/189 (0.00%) 
# events   0   0   0   1   0   0 
General disorders             
hospitalization: general †             
# participants affected / at risk   1/262 (0.38%)   2/260 (0.77%)   0/267 (0.00%)   1/264 (0.38%)   2/262 (0.76%)   0/189 (0.00%) 
# events   1   2   0   1   2   0 
Pregnancy, puerperium and perinatal conditions             
Pregnancy † [3]             
# participants affected / at risk   0/262 (0.00%)   0/260 (0.00%)   0/267 (0.00%)   1/264 (0.38%)   0/262 (0.00%)   1/189 (0.53%) 
# events   0   0   0   1   0   1 
Psychiatric disorders             
Hospitalization: psychiatric and alcohol †             
# participants affected / at risk   0/262 (0.00%)   0/260 (0.00%)   0/267 (0.00%)   1/264 (0.38%)   0/262 (0.00%)   0/189 (0.00%) 
# events   0   0   0   1   0   0 
Respiratory, thoracic and mediastinal disorders             
hospitalization: respiratory †             
# participants affected / at risk   0/262 (0.00%)   0/260 (0.00%)   1/267 (0.37%)   1/264 (0.38%)   0/262 (0.00%)   3/189 (1.59%) 
# events   0   0   1   1   0   3 
Death: COPD †             
# participants affected / at risk   0/262 (0.00%)   0/260 (0.00%)   0/267 (0.00%)   0/264 (0.00%)   1/262 (0.38%)   0/189 (0.00%) 
# events   0   0   0   0   1   0 
Skin and subcutaneous tissue disorders             
Skin reaction †             
# participants affected / at risk   1/262 (0.38%)   0/260 (0.00%)   0/267 (0.00%)   0/264 (0.00%)   0/262 (0.00%)   0/189 (0.00%) 
# events   1   0   0   0   0   0 
Surgical and medical procedures             
hospitalization: surgical †             
# participants affected / at risk   2/262 (0.76%)   0/260 (0.00%)   3/267 (1.12%)   0/264 (0.00%)   3/262 (1.15%)   0/189 (0.00%) 
# events   2   0   3   0   3   0 
Events were collected by systematic assessment
* Events were collected by non-systematic assessment
[3] Pregnancy




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


Results Point of Contact:  
Name/Title: Piper, Megan E
Organization: University of Wisconsin
phone: 608-265-5472
e-mail: mep@ctri.medicine.wisc.edu


Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):


Responsible Party: University of Wisconsin, Madison
ClinicalTrials.gov Identifier: NCT00332644     History of Changes
Obsolete Identifiers: NCT00109447
Other Study ID Numbers: P50DA19706-1
P50DA019706 ( US NIH Grant/Contract Award Number )
Study First Received: June 1, 2006
Results First Received: October 21, 2011
Last Updated: October 21, 2011
Health Authority: United States: Federal Government