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Long-term Varenicline Treatment for Smoking Cessation

This study has been completed.
Sponsor:
Collaborator:
Pfizer
Information provided by (Responsible Party):
Douglas Jorenby, University of Wisconsin, Madison
ClinicalTrials.gov Identifier:
NCT00828113
First received: January 21, 2009
Last updated: January 14, 2013
Last verified: January 2013
History of Changes
Results First Received: June 13, 2012  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Smoking
Interventions: Drug: varenicline
Behavioral: Individual smoking cessation counseling

  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
No text entered.

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
Extended Treatment 52-week varenicline therapy + individual smoking cessation counseling
Standard Treatment 13 weeks of varenicline therapy + individual smoking cessation counseling

Participant Flow:   Overall Study
    Extended Treatment     Standard Treatment  
STARTED     50     51  
COMPLETED     20     20  
NOT COMPLETED     30     31  
Withdrawal by Subject                 27                 26  
Lost to Follow-up                 3                 5  



  Baseline Characteristics
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Reporting Groups
  Description
Extended Treatment 52-week varenicline therapy + individual smoking cessation counseling
Standard Treatment 13 weeks of varenicline therapy + individual smoking cessation counseling
Total Total of all reporting groups

Baseline Measures
    Extended Treatment     Standard Treatment     Total  
Number of Participants  
[units: participants]
 		  50     51     101  
Age  
[units: participants]
 		     
<=18 years     0     0     0  
Between 18 and 65 years     50     51     101  
>=65 years     0     0     0  
Age  
[units: years]
Mean ± Standard Deviation 		  42.6  ± 11.6     43.2  ± 12.4     42.9  ± 12.0  
Gender  
[units: participants]
 		     
Female     21     22     43  
Male     29     29     58  
Region of Enrollment  
[units: participants]
 		     
United States     50     51     101  



  Outcome Measures

1.  Primary:   Number of Participants Not Smoking in the Previous 7 Days, Confirmed by Expired Carbon Monoxide Reading < 10 Parts Per Million at Week 52   [ Time Frame: 7-day point prevalence ]
  Show Outcome Measure 1


  Serious Adverse Events
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  Other Adverse Events
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS 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.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.


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
Feasibility study with limited statistical power at baseline compounded by a significant rate of attrition during the study.  


Results Point of Contact:  
Name/Title: Douglas E. Jorenby, Ph.D.
Organization: University of Wisconsin School of Medicine and Public Health
phone: 6082627527
e-mail: dej@ctri.medicine.wisc.edu


No publications provided


Responsible Party: Douglas Jorenby, University of Wisconsin, Madison
ClinicalTrials.gov Identifier: NCT00828113     History of Changes
Other Study ID Numbers: H-2008-0149
Study First Received: January 21, 2009
Results First Received: June 13, 2012
Last Updated: January 14, 2013
Health Authority: United States: Institutional Review Board