Chantix & Bupropion for Smoking Cessation (ChanBan)
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|ClinicalTrials.gov Identifier: NCT00587769|
Recruitment Status : Completed
First Posted : January 7, 2008
Results First Posted : December 23, 2010
Last Update Posted : April 24, 2013
|Condition or disease||Intervention/treatment||Phase|
|Smoking Tobacco Use Disorder||Drug: Bupropion SR & Varenicline||Phase 3|
Subjects will be eligible to participate if they: 1) are at least 18 years of age; 2) have smoked 10 or more cigarettes per day for at least 6 months; and 3) are motivated to stop smoking.
Subjects will be excluded if they have: 1) an unstable medical condition; 2) unstable angina, myocardial infarction, or coronary angioplasty within the past 3 months or an untreated cardiac dysrhythmia; 3) personal history of seizures; 4) closed head trauma with any loss of consciousness or amnesia in the last 5 years; 5) ever history of closed head trauma with > 30 minutes of loss of consciousness or amnesia or resulting in skull fracture or subdural hematoma/brain contusion; 6) a history or psychosis, bipolar disorder, bulimia or anorexia nervosa); 7) have current depression as assessed by Center for Epidemiologic Studies Depression (CES-D); 8) have active substance abuse other than nicotine; 9) have used an investigational drug within the last 30 days; 10) are currently using a behavioral or pharmacologic tobacco treatment and unwilling or unable to discontinue use; 11) use of bupropion or varenicline in the previous 3 months; 12) current (past 14 days) use of antipsychotic or antidepressant; 13) an allergy to bupropion or varenicline; 14) untreated hypertension or baseline systolic blood pressure > 180 or diastolic > 100; 15) have another member of their household already participating in this study.
The primary aims and hypotheses of this study are:
To obtain preliminary evidence of efficacy of 12 weeks of combination therapy with bupropion SR and varenicline for increasing the point prevalence smoking abstinence rates at 12 weeks among cigarette smokers.
Hypothesis: The combination of bupropion SR plus varenicline for 12 weeks will increase the point prevalence smoking abstinence rates at 12 weeks among cigarettes smokers.
- To obtain preliminary evidence of efficacy of combination therapy with bupropion SR and varenicline for decreasing craving and nicotine withdrawal symptoms among cigarette smokers trying to achieve smoking abstinence.
Hypothesis: 12 weeks of combination therapy with bupropion SR and varenicline will significantly decrease craving and nicotine withdrawal among cigarette smokers trying to achieve smoking abstinence.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||38 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Combination Pharmacotherapy With Chantix & Bupropion for Smoking Cessation (ChanBan)|
|Study Start Date :||July 2007|
|Actual Primary Completion Date :||July 2008|
|Actual Study Completion Date :||July 2008|
Experimental: Bupropion SR & Varenicline
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.
Drug: Bupropion SR & Varenicline
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.
- Point Prevalence Smoking Abstinence at 12 Weeks: the Number of Patients Who Refrained From Smoking at 12 Weeks [ Time Frame: 12 weeks ]Smoking abstinence biochemically confirmed with exhaled carbon monoxide concentrations
- Point Prevalence Smoking Abstinence at 6 Months: the Number of Patients Who Refrained From Smoking at 6 Months [ Time Frame: 6 months ]Smoking abstinence biochemically confirmed with exhaled carbon monoxide concentrations
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00587769
|United States, Minnesota|
|Rochester, Minnesota, United States, 55902|
|Principal Investigator:||Jon O Ebbert, MD||Mayo Clinic|