Official Title: “Combination Pharmacotherapy With Chantix & Bupropion for Smoking Cessation (ChanBan)”

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.

Study Type: Interventional

Study Design: Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study

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:

1. 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.

2. 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.

Intervention(s) in this Clinical Trial

• Drug: Chantix (Varenicline) & Bupropion
  • 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.

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: A
  • 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.

Primary Measures

• 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.
  • Time Frame: 12 weeks
    Safety Issue?: No

Secondary Measures

• 1. To assess the types and frequencies of side effects with 12 weeks of combination therapy with bupropion SR and varenicline for the treatment of tobacco dependence among cigarette smokers.
  • Time Frame: 12 weeks
    Safety Issue?: Yes

Inclusion Criteria:

• at least 18 years of age
• have smoked 10 or more cigarettes per day for at least 6 months
• are motivated to stop smoking.

Exclusion Criteria:

• an unstable medical condition
• unstable angina, myocardial infarction, or coronary angioplasty within the past 3 months or an untreated cardiac dysrhythmia
• personal history of seizures
• closed head trauma with any loss of consciousness or amnesia in the last 5 years
• 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
• a history or psychosis, bipolar disorder, bulimia or anorexia nervosa)
• have current depression as assessed by Center for Epidemiologic Studies Depression (CES-D)
• have active substance abuse other than nicotine
• have used an investigational drug within the last 30 days
• are currently using a behavioral or pharmacologic tobacco treatment and unwilling or unable to discontinue use
• use of bupropion or varenicline in the previous 3 months
• current (past 14 days) use of antipsychotic or antidepressant
• an allergy to bupropion or varenicline
• untreated hypertension or baseline systolic blood pressure > 180 or diastolic > 100
• have another member of their household already participating in this study.

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: Accepts Healthy Volunteers

Lead Sponsor: Mayo Clinic

Overall Clinical Trial Officials and Contacts

Jon O Ebbert, MD Principal Investigator Mayo Clinic  

Information obtained from ClinicalTrials.gov on September 05, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00587769

Study ID Number: 07-003998

ClinicalTrials.gov Identifier: NCT00587769

Health Authority: United States: Food and Drug Administration

Mayo Clinic Nicotine Research Program

Mayo Clinic Clinical Trials