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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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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Recruitment began on 4/13/09 and completed on 08/16/10. Interested subjects who passed a phone pre-screen were seen at a medical clinic (Mayo Clinic in Rochester, MN and Franciscan Skemp Medical Center in Lacrosse, WI) for consenting and additional study procedures to determine eligibility.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Varenicline varenicline-1mg/day for 12 weeks
Placebo nonactive lookalike pill per day for 12 weeks

Participant Flow:   Overall Study
    Varenicline     Placebo  
STARTED     38     38  
COMPLETED     32     32  
NOT COMPLETED     6     6  
Adverse Event                 0                 1  
Withdrawal by Subject                 3                 4  
Lost to Follow-up                 3                 1  



  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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Measure Type Primary
Measure Title 7-day Point Prevalence All Tobacco Abstinence
Measure Description 7-day point prevalence all tobacco abstinence at week 12 (end of treatment)confirmed by urine cotinine less than 50ng/ml
Time Frame 12 weeks - end of treatment  
Safety Issue No  

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
Varenicline varenicline-1mg/day for 12 weeks
Placebo nonactive lookalike pill per day for 12 weeks

Measured Values
    Varenicline     Placebo  
Number of Participants Analyzed  
[units: participants]
 		  38     38  
7-day Point Prevalence All Tobacco Abstinence  
[units: participants]
 		  21     16  


Statistical Analysis 1 for 7-day Point Prevalence All Tobacco Abstinence
Groups [1] All groups
Method [2] Chi-squared
P Value [3] 0.126
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  Data were compared between treatment groups using Chi Square test.
[2] Other relevant information, such as adjustments or degrees of freedom:
  1 sided
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  For this randomized phase II we used a one sided test with a false positive(type I error)rate of 0.20 to assess whether additional studies of the experimental arm are warranted.




  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
No text entered.  


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