Now Available: Final Rule for FDAAA 801 and NIH Policy on Clinical Trial Reporting

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


  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 
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


  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
No text entered.


  More Information