NCT00587769|CompletedPhase 3Results
Chantix & Bupropion for Smoking Cessation
ChanBan
Combination Pharmacotherapy With Chantix & Bupropion for Smoking Cessation (ChanBan)
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Sponsor study identifier
interventional
38
1 country
1
Study Start
July 2007
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
July 2008
Actual (reported)Study Completion
July 2008
Actual (reported)The overarching goal of this line of research is to increase smoking abstinence rates using a combination of existing pharmacotherapies. The aim of the current study is to assess the safety and compliance as well as obtain preliminary estimates of efficacy and effect on craving and nicotine withdrawal of combination therapy with bupropion SR and varenicline. We will compare the efficacy estimates in this study with historical smoking abstinence rates with varenicline. To accomplish our aims, we will enroll 38 cigarette smokers in an open-label, phase II clinical trial.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
July 2008
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
July 2007
Date type not reportedThis date has not been verified as actual or estimated.
December 21, 2007
Actual (reported)January 7, 2008
Actual (reported)July 2008
Actual (reported)July 2008
Actual (reported)December 23, 2010
Actual (reported)Point Prevalence Smoking Abstinence at 12 Weeks: the Number of Patients Who Refrained From Smoking at 12 Weeks
Smoking abstinence biochemically confirmed with exhaled carbon monoxide concentrations
12 weeks
Point Prevalence Smoking Abstinence at 6 Months: the Number of Patients Who Refrained From Smoking at 6 Months
6 months
All 38 smokers will receive open-label bupropion SR and varenicline. Bupropion SR is an oral medication with recommended dosing of 150 mg by mouth once day for 3 days then 150 mg by mouth twice per day. Varenicline is an oral medication with recommended dosing of 0.5 mg once daily for 3 days, increasing to 0.5 mg twice daily for days 4 to 7, and then to the maintenance dose of 1 mg twice daily for the 12 weeks of treatment. Subjects will quit on Day #8 after starting both medications.
Bupropion SR 150 mg by mouth once day for 3 days then 150 mg by mouth twice per day. Varenicline 0.5 mg once daily for 3 days, increasing to 0.5 mg twice daily for days 4 to 7, and then to the maintenance dose of 1 mg twice daily for the 12 weeks of treatment.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
These entries preserve how the registry describes the intervention. Their treatment roles are shown separately from molecular identities.
Grouped treatment entry
Bupropion SR & Varenicline
The registry names several treatments. This does not confirm that participants received them together or that they form a single product.
View registry recordMayo Clinic
Rochester, Minnesota, 55902, United States
Jon O Ebbert, MD
Mayo Clinic
38 participants (actual enrollment reported by the registry).
First Submitted
December 21, 2007
First Posted
January 7, 2008
Study Start
July 2007
Date type not reportedThis date has not been verified as actual or estimated.
Smoking Termination Enhancement Project (STEP)
Contact the study team to confirm eligibility.
Primary Completion
July 2008
Actual (reported)Study Completion
July 2008
Actual (reported)Last Updated
April 24, 2013
Results First Posted
December 23, 2010
Record last verified: 2013-04
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Source: ClinicalTrials.gov.
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