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Varenicline for the Treatment of Smokeless Tobacco (CHANCHEW)

This study has been completed.
Sponsor:
Collaborator:
National Institutes of Health (NIH)
Information provided by (Responsible Party):
Jon Ebbert, Mayo Clinic
ClinicalTrials.gov Identifier:
NCT00813917
First received: December 22, 2008
Last updated: July 10, 2012
Last verified: July 2012
History of Changes
Results First Received: August 5, 2011  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Nicotine Dependence
Interventions: Drug: varenicline
Drug: placebo

  Participant Flow
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  Baseline Characteristics
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Reporting Groups
  Description
Varenicline varenicline-1mg/day for 12 weeks
Placebo nonactive lookalike pill per day for 12 weeks
Total Total of all reporting groups

Baseline Measures
    Varenicline     Placebo     Total  
Number of Participants  
[units: participants]
 		  38     38     76  
Age  
[units: participants]
 		     
<=18 years     0     0     0  
Between 18 and 65 years     38     36     74  
>=65 years     0     2     2  
Age  
[units: years]
Mean ± Standard Deviation 		  41.0  ± 12.4     40.7  ± 10.1     40.9  ± 11.2  
Gender  
[units: participants]
 		     
Female     0     0     0  
Male     38     38     76  
smokeless tobacco quantity [1]
[units: cans per week]
Mean ± Standard Deviation 		  4.0  ± 3.5     3.2  ± 2.0     3.6  ± 2.9  
[1] Amount of smokeless tobacco used per week



  Outcome Measures

1.  Primary:   7-day Point Prevalence All Tobacco Abstinence   [ Time Frame: 12 weeks - end of treatment ]
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  Serious Adverse Events
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  Other Adverse Events
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  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


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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Results Point of Contact:  
Name/Title: Jon O. Ebbert, MD
Organization: Mayo Clinic
phone: 507-266-1944
e-mail: nicotineresearch@mayo.edu


Publications of Results:


Responsible Party: Jon Ebbert, Mayo Clinic
ClinicalTrials.gov Identifier: NCT00813917     History of Changes
Other Study ID Numbers: 08-005359, CA132621-01A1
Study First Received: December 22, 2008
Results First Received: August 5, 2011
Last Updated: July 10, 2012
Health Authority: United States: Institutional Review Board