Smoking Cessation Medications: Efficacy, Mechanisms and Algorithms

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00332644
Recruitment Status : Completed
First Posted : June 2, 2006
Results First Posted : November 30, 2011
Last Update Posted : November 30, 2011
National Institute on Drug Abuse (NIDA)
Information provided by (Responsible Party):
University of Wisconsin, Madison

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Single Group Assignment;   Masking: Double (Participant, 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

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
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

  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

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

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 ( U.S. NIH Grant/Contract )
First Submitted: June 1, 2006
First Posted: June 2, 2006
Results First Submitted: October 21, 2011
Results First Posted: November 30, 2011
Last Update Posted: November 30, 2011