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Smoking Cessation Medications: Efficacy, Mechanisms and Algorithms

This study has been completed.
National Institute on Drug Abuse (NIDA)
Information provided by (Responsible Party):
University of Wisconsin, Madison Identifier:
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.
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Reporting Groups
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 
[units: participants]
 262   260   267   264   262   189   1504 
[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 
[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) 
[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
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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

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

Responsible Party: University of Wisconsin, Madison 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