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Smoking Cessation Intervention: Effectiveness in Primary Care

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:
NCT00296647
First received: February 24, 2006
Last updated: October 9, 2015
Last verified: October 2015
Results First Received: October 21, 2011  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Tobacco Dependence
Interventions: Drug: nicotine patch
Drug: nicotine lozenge
Drug: bupropion
Drug: patch + lozenge
Drug: bupropion + lozenge

  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
Participants were 1346 smokers recruited in 12 Aurora Health Care primary care clinics in eastern Wisconsin from October 2005 through May 2007.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Primary inclusion criteria included (1) 18 years or older; (2) 10 or more cigarettes per day (CPD) for the past 6 months; (3) motivated to quit smoking; and (4) if female, willing to use an acceptable contraception while using the study medication.

Reporting Groups
  Description
Patch No text entered.
Nicotine Lozenge No text entered.
Bupropion No text entered.
Patch + Lozenge No text entered.
Buproion + Lozenge No text entered.

Participant Flow:   Overall Study
    Patch   Nicotine Lozenge   Bupropion   Patch + Lozenge   Buproion + Lozenge
STARTED   282   261   256   279   268 
COMPLETED   250   233   222   262   248 
NOT COMPLETED   32   28   34   17   20 
Death                4                1                2                1                1 
Withdrawal by Subject                28                27                32                16                19 



  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.
No text entered.

Reporting Groups
  Description
Patch No text entered.
Nicotine Lozenge No text entered.
Bupropion No text entered.
Patch + Lozenge No text entered.
Buproion + Lozenge No text entered.
Total Total of all reporting groups

Baseline Measures
   Patch   Nicotine Lozenge   Bupropion   Patch + Lozenge   Buproion + Lozenge   Total 
Overall Participants Analyzed 
[Units: Participants]
 282   261   256   279   268   1346 
Age 
[Units: Years]
Mean (Standard Deviation)
 44.5  (12.4)   42.9  (11.7)   44  (11.6)   44.8  (12.4)   45.4  (12.2)   44.3  (12.1) 
Gender 
[Units: Participants]
           
Female   158   142   143   158   152   753 
Male   124   119   113   121   116   593 
Region of Enrollment 
[Units: Participants]
           
United States   282   261   256   279   268   1346 


  Outcome Measures

1.  Primary:   6 Month Self-reported Abstinence From Smoking   [ Time Frame: 6 months ]


  Serious Adverse Events


  Other Adverse Events
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Time Frame 6 months collection at scheduled follow up time points
Additional Description No text entered.

Frequency Threshold
Threshold above which other adverse events are reported   5  

Reporting Groups
  Description
Patch No text entered.
Nicotine Lozenge No text entered.
Bupropion No text entered.
Patch + Lozenge No text entered.
Buproion + Lozenge No text entered.

Other Adverse Events
    Patch   Nicotine Lozenge   Bupropion   Patch + Lozenge   Buproion + Lozenge
Total, other (not including serious) adverse events           
# participants affected / at risk   18/282 (6.38%)   15/261 (5.75%)   12/256 (4.69%)   13/279 (4.66%)   6/268 (2.24%) 
Gastrointestinal disorders           
nausea           
# participants affected / at risk   3/282 (1.06%)   12/261 (4.60%)   6/256 (2.34%)   8/279 (2.87%)   3/268 (1.12%) 
# events   3   12   6   8   3 
Skin and subcutaneous tissue disorders           
skin irritation           
# participants affected / at risk   15/282 (5.32%)   3/261 (1.15%)   6/256 (2.34%)   5/279 (1.79%)   3/268 (1.12%) 
# events   15   3   6   5   3 
* Events were collected by non-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
The present study is limited to some extent by the fact that self-reported abstinence was not biochemically confirmed. However, there is evidence that self-reported abstinence rates are generally accurate in low-contact effectiveness studies.


  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Stevens Smith, PhD
Organization: UW-Center for Tobacco Research and Intervention
phone: 608-262-7563
e-mail: sss@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: NCT00296647     History of Changes
Obsolete Identifiers: NCT00106873
Other Study ID Numbers: H-2004-0462
P50DA019706 ( US NIH Grant/Contract Award Number )
Study First Received: February 24, 2006
Results First Received: October 21, 2011
Last Updated: October 9, 2015
Health Authority: United States: Federal Government