SmokingPhase 3ChanBanNCT00587769
Chantix & Bupropion for Smoking Cessation
A Phase 3 study testing Bupropion SR & Varenicline in people with Smoking and Tobacco Use Disorder, run by Mayo Clinic at 1 site in United States.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Smoking, Tobacco Use Disorder
- What is being tested?
- Bupropion SR & Varenicline
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 38 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2007to Jul 2008
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- at least 18 years of age
- have smoked 10 or more cigarettes per day for at least 6 months
- are motivated to stop smoking.
Who cannot join
- 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)
Show all 15Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the detailed description
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.
- Conditions
- Smoking, Tobacco Use Disorder
- Being tested
- Bupropion SR & Varenicline
- Keywords
- Smoking, Smoking cessation, Bupropion, Varenicline, Tobacco use disorder
- Medical subject headings
- Smoking, Tobacco Use Disorder, Smoking Cessation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bupropion SR & VareniclineDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| Bupropion SR & Varenicline | Experimental | 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. Receives: Drug: Bupropion SR & Varenicline |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 12 weeks
Secondary outcomes (1)
Point Prevalence Smoking Abstinence at 6 Months: the Number of Patients Who Refrained From Smoking at 6 Months
Smoking abstinence biochemically confirmed with exhaled carbon monoxide concentrations
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jan 2008 (estimated)
- Study startJul 2007
- Primary completionJul 2008
- Study completionJul 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for SmokingStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jon Ebbert, Mayo Clinic
- Investigators
- Jon O Ebbert, MD, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00587769
- Sponsor's protocol ID
- 07-003998
- Acronym
- ChanBan
- Status last verified
- Apr 2013
- First submitted
- 21 Dec 2007
- Last updated
- 24 Apr 2013
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Combination Pharmacotherapy With Chantix & Bupropion for Smoking Cessation (ChanBan)
- ClinicalTrials.gov ID
- NCT00587769
- Acronym / sponsor ID
- ChanBan / 07-003998
- Conditions
- Smoking, Tobacco Use Disorder
- Keywords
- Smoking, Smoking cessation, Bupropion, Varenicline, Tobacco use disorder
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- Jul 2007
- Primary completion
- Jul 2008 (actual)
- Study completion
- Jul 2008 (actual)
- First posted
- 7 Jan 2008 (estimated)
- Results
- Posted 23 Dec 2010
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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 design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Bupropion SR & Varenicline | Experimental | Drug: Bupropion SR & VareniclineAll 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- at least 18 years of age
- have smoked 10 or more cigarettes per day for at least 6 months
- are motivated to stop smoking.
Key exclusion criteria (15 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Bupropion SR & VareniclineBupropion 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. | Drug | Bupropion SR & Varenicline |
Primary outcome
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
1 secondary outcome
Point Prevalence Smoking Abstinence at 6 Months: the Number of Patients Who Refrained From Smoking at 6 Months
Time frame: 6 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Apr 2013.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jon O Ebbert, MD principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Bupropion SR & Varenicline in people with Smoking and Tobacco Use Disorder, run by Mayo Clinic at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Apr 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 23 Dec 2010). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the 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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Apr 2013.