Chantix & Bupropion for Smoking Cessation (ChanBan)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Jon Ebbert, Mayo Clinic
ClinicalTrials.gov Identifier:
NCT00587769
First received: December 21, 2007
Last updated: April 16, 2013
Last verified: April 2013
Results First Received: October 5, 2010  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Conditions: Smoking
Tobacco Use Disorder
Intervention: Drug: Bupropion SR & Varenicline

  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
Patient's were recruited between 10 September, 2007 and 25 October, 2007 in the community surrounding the Mayo Clinic in Rochester Minnesota.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Patients were excluded for not meeting entry criteria

Reporting Groups
  Description
Medication Arm Varenicline 1.0 mg po bid plus bupropion 150 mg po bid

Participant Flow:   Overall Study
    Medication Arm  
STARTED     38  
COMPLETED     38  
NOT COMPLETED     0  



  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
Medication Arm Varenicline 1.0 mg po bid plus bupropion 150 mg po bid

Baseline Measures
    Medication Arm  
Number of Participants  
[units: participants]
  38  
Age  
[units: years]
Median ± Standard Deviation
  49.1  ± 12.4  
Gender  
[units: participants]
 
Female     17  
Male     21  
Cigarettes per day  
[units: cigarettes per day]
Mean ± Standard Deviation
  19.9  ± 7.8  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Point Prevalence Smoking Abstinence at 12 Weeks: the Number of Patients Who Refrained From Smoking at 12 Weeks   [ Time Frame: 12 weeks ]

2.  Secondary:   Point Prevalence Smoking Abstinence at 6 Months: the Number of Patients Who Refrained From Smoking at 6 Months   [ Time Frame: 6 months ]


  Serious Adverse Events


  Other Adverse Events


  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
Organization: Mayo Clinic
phone: 507-284-2511
e-mail: ebbert.jon@mayo.edu


No publications provided


Responsible Party: Jon Ebbert, Mayo Clinic
ClinicalTrials.gov Identifier: NCT00587769     History of Changes
Other Study ID Numbers: 07-003998
Study First Received: December 21, 2007
Results First Received: October 5, 2010
Last Updated: April 16, 2013
Health Authority: United States: Food and Drug Administration