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

December 21, 2007
April 16, 2013
July 2007
July 2008   (final data collection date for primary outcome measure)
Point Prevalence Smoking Abstinence at 12 Weeks: the Number of Patients Who Refrained From Smoking at 12 Weeks [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
Smoking abstinence biochemically confirmed with exhaled carbon monoxide concentrations
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 ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00587769 on ClinicalTrials.gov Archive Site
Point Prevalence Smoking Abstinence at 6 Months: the Number of Patients Who Refrained From Smoking at 6 Months [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
Smoking abstinence biochemically confirmed with exhaled carbon monoxide concentrations
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 ] [ Designated as safety issue: Yes ]
Not Provided
Not Provided
 
Chantix & Bupropion for Smoking Cessation
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.

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.

Interventional
Phase 3
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Smoking
  • Tobacco Use Disorder
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.

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.
Intervention: Drug: Bupropion SR & Varenicline
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
38
July 2008
July 2008   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00587769
07-003998
No
Jon Ebbert, Mayo Clinic
Mayo Clinic
Not Provided
Principal Investigator: Jon O Ebbert, MD Mayo Clinic
Mayo Clinic
April 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP