SmokingPhase 2/3CHANBANNCT00935818
Varenicline and Bupropion for Smoking Cessation
A Phase 2/3 study testing Varenicline and bupropion SR in people with Smoking, run by Mayo Clinic at 3 sites in United States.
Trial summary
This study provides an opportunity to combine varenicline and bupropion SR and capitalize on the potential additive benefit. The investigators hypothesize that this will further increase long-term (≥ 6 months) smoking abstinence rates. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Smoking
- What is being tested?
- Varenicline and bupropion SR
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 506 participants
- Where
- 3 sitesUnited States
- Study dates
- Sep 2009to Apr 2013
- Phase
- Phase 2/3
- 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
- Subject is at least 18 years of age;
- Subject has provide written informed consent;
- Subject is smoking greater than or equal to 10 cigarettes per day for at least 6 months;
- 3) Subject is able to complete all study visits 4) Subject is in good health as determined by the investigator 5) Subject has the ability to participate fully in all aspects of the study and keep scheduled appointments 6) Subject is motivated to stop smoking.
Who cannot join
- Female and were pregnant, lactating or likely to become pregnant during the trial and not able nor willing to use contraception or had:
- an unstable medical condition;
- another household member participating in the study;
- bupropion or varenicline allergy;
- current use (previous 30 days) of a tobacco dependence treatment and unable or unwilling to discontinue use;
- an unstable medical condition or unstable angina, myocardial infarction, or coronary angioplasty (past 3 months) or an untreated cardiac dysrhythmia;
Show all 18Show fewer
- a history of renal failure or were on renal dialysis;
- a history of seizures;
- as defined by the C-SSRS (Columbia-Suicide Severity Rating Scale), current non-specific suicidal thoughts or lifetime history of a suicidal attempt (defined as "potentially self-injurious act committed with at least some wish to die, as a result of act");
- a history of closed head trauma associated with > 30 minutes of loss of consciousness, amnesia, skull fracture, subdural hematoma, or brain contusion;
- a history or psychosis, bipolar disorder, bulimia or anorexia nervosa;
- current moderate or severe depression as assessed by a score of ≥ 20 on the Beck Depression Inventory, Second Edition (BDI-II) 10;
- active substance abuse other than nicotine;
- current (past 14 days) use of an antipsychotic, monoamine oxidase inhibitors, or drugs known to interact with bupropion SR;
- a recent dose change of their antidepressant (within last 3 months);
- untreated hypertension or baseline systolic blood pressure > 180 or diastolic > 100;
- current treatment with another investigational drug for tobacco dependence (previous 30 days); or
- current use of bupropion or varenicline (previous 30 days).
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Franciscan Skemp Hospital
La Crosse, Wisconsin, 54601
University Of Minnesota
Minneapolis, Minnesota, 55414
Mayo Clinic
Rochester, Minnesota, 55905
About this study
Official title: Combination Therapy With Varenicline and Bupropion for Smoking Cessation
This study provides an opportunity to combine varenicline and bupropion SR and capitalize on the potential additive benefit. The investigators hypothesize that this will further increase long-term (≥ 6 months) smoking abstinence rates.
Read the detailed description
Cigarette smoking is the single most important preventable cause of morbidity, mortality and excess health care costs in the United States and accounts for 30% of U.S. cancer deaths. Varenicline and bupropion SR (sustained-release) are non nicotine pharmacotherapies FDA-indicated for the treatment of tobacco dependence in cigarette smokers. Although varenicline has proven greater efficacy than bupropion SR, both medications are associated with high end-of-treatment smoking abstinence rates. However, almost two-thirds of smokers treated with varenicline report smoking at 6 months. Because varenicline and bupropion SR have different mechanisms of action and different neuropharmacologic targets, combination pharmacotherapy with these agents may increase long-term smoking abstinence rates above what is observed with single-agent therapy. In our recent pilot study of combination therapy with varenicline and bupropion SR, we observed treatment to be well-tolerated with 7-day point prevalence smoking abstinence rates of 71% (95% CI: 54-85%) at 3 months and 58% (95% CI: 41-74%) at 6 months. Determining the efficacy of combination therapy compared to single-agent therapy has immediate and important clinical implications. In this study, we will conduct a randomized, multicenter, controlled clinical trial evaluating the efficacy of combination therapy with varenicline and bupropion SR compared to varenicline and placebo in 506 cigarette smokers at the Mayo Clinic in Rochester, MN, and the University of Minnesota in Minneapolis, MN.
- Conditions
- Smoking
- Being tested
- Varenicline, placebo, bupropion SR
- Keywords
- smoking, nicotine, tobacco, dependence, cessation, abstinence
- Medical subject headings
- Smoking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VareniclineDrug
Also called chantix
varenicline - 1 mg bid for 12 weeks
placeboDrug
Also called sugar pill
placebo for 12 weeks
bupropion SRDrug
Also called wellbutrin SR, zyban
bupropion sr - 150 mg bid for 12 weeks
| Study group | Role | What they receive |
|---|---|---|
| varenicline and buproprion SR | Active comparator | Everyone randomized to this arm will receive varenicline (up to 1mg bid) and bupropion SR (150 mg bid)for 12 weeks. They will be followed up by study for an additional 9 months post end of medication - for a total of 1 year study participation. Everyone will receive behavioral counseling for the full year. Receives: Drug: Varenicline; Drug: bupropion SR |
| varenicline and placebo | Placebo comparator | Everyone randomized to this arm will receive varenicline (up to 1mg bid) and placebo (0 mg bid)for 12 weeks. They will be followed up by study for an additional 9 months post end of medication - for a total of 1 year study participation. Everyone will receive behavioral counseling for the full year. Receives: Drug: Varenicline; Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prolonged Smoking Abstinence Rates at 12 Weeks in Cigarettes Smokers.
Prolonged smoking abstinence is defined as no smoking, not even a puff, in the last 7 days, and a negative response to the question "Since 2 weeks after your target quit date, have you smoked any tobacco, even a puff, for 7 consecutive days or at least once each week on 2 consecutive weeks?"
Measured: 3 months
Point Prevalence Abstinence at 3 Months.
biochemically confirmed 7-day point prevalence abstinence defined as no smoking, not even a puff, in the previous 7 days.
Measured: 3 months
Secondary outcomes (5)
Prolonged Smoking Abstinence Rates at 26 Weeks in Cigarettes Smokers.
Measured: 6 months
Weight Gain From Baseline to 3 Months
Weight change from baseline to three months in those who met criteria for prolonged abstinence at the 3 month visit
Measured: 3 months
Point Prevalence Abstinence at 6 Months.
Biochemically confirmed abstinence as no smoking, even a puff, for the prior 7 days.
Measured: 6 months
Prolonged Abstinence at 12 Months
Measured: 12 months
Point Prevalence Abstinence at 12 Months
Biochemically confirmed abstinence defined as no smoking, not even a puff, in the last 7 days
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jul 2009 (estimated)
- Study startSep 2009
- Primary completionApr 2013
- Study completionApr 2013
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.
- Publications (3)Papers the sponsor has linked to this study.
- 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 506 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI), University of Minnesota
- Responsible party
- Principal investigator, Jon Ebbert, Mayo Clinic
- Investigators
- Jon Ebbet, MD, Principal investigator, Mayo ClinicDorothy Hatsukami, PhD, Study director, University of Minnesota
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00935818
- Sponsor's protocol ID
- 09-003598
- Other IDs
- 09-002459, 1R01CA138417
- Acronym
- CHANBAN
- Status last verified
- Apr 2014
- First submitted
- 6 Jul 2009
- Last updated
- 9 May 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Ebbert JO, Hatsukami DK, Croghan IT, Schroeder DR, Allen SS, Hays JT, Hurt RD. Combination varenicline and bupropion SR for tobacco-dependence treatment in cigarette smokers: a randomized trial. JAMA. 2014 Jan 8;311(2):155-63. doi: 10.1001/jama.2013.283185.
PubMed 24399554Livingstone-Banks J, Fanshawe TR, Thomas KH, Theodoulou A, Hajizadeh A, Hartman L, Lindson N. Nicotine receptor partial agonists for smoking cessation. Cochrane Database Syst Rev. 2023 May 5;5(5):CD006103. doi: 10.1002/14651858.CD006103.pub8.
PubMed 37142273Hartmann-Boyce J, Theodoulou A, Farley A, Hajek P, Lycett D, Jones LL, Kudlek L, Heath L, Hajizadeh A, Schenkels M, Aveyard P. Interventions for preventing weight gain after smoking cessation. Cochrane Database Syst Rev. 2021 Oct 6;10(10):CD006219. doi: 10.1002/14651858.CD006219.pub4.
PubMed 34611902
Study at a glance
From the registry record, last updated by the sponsor on 9 May 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Combination Therapy With Varenicline and Bupropion for Smoking Cessation
- ClinicalTrials.gov ID
- NCT00935818
- Acronym / sponsor ID
- CHANBAN / 09-003598
- Conditions
- Smoking
- Keywords
- smoking, nicotine, tobacco, dependence, cessation, abstinence
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 506 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI), University of Minnesota
- Study start
- Sep 2009
- Primary completion
- Apr 2013 (actual)
- Study completion
- Apr 2013 (actual)
- First posted
- 9 Jul 2009 (estimated)
- Results
- Posted 24 Apr 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study provides an opportunity to combine varenicline and bupropion SR and capitalize on the potential additive benefit. The investigators hypothesize that this will further increase long-term (≥ 6 months) smoking abstinence rates.
Detailed description
Cigarette smoking is the single most important preventable cause of morbidity, mortality and excess health care costs in the United States and accounts for 30% of U.S. cancer deaths. Varenicline and bupropion SR (sustained-release) are non nicotine pharmacotherapies FDA-indicated for the treatment of tobacco dependence in cigarette smokers. Although varenicline has proven greater efficacy than bupropion SR, both medications are associated with high end-of-treatment smoking abstinence rates. However, almost two-thirds of smokers treated with varenicline report smoking at 6 months. Because varenicline and bupropion SR have different mechanisms of action and different neuropharmacologic targets, combination pharmacotherapy with these agents may increase long-term smoking abstinence rates above what is observed with single-agent therapy. In our recent pilot study of combination therapy with varenicline and bupropion SR, we observed treatment to be well-tolerated with 7-day point prevalence smoking abstinence rates of 71% (95% CI: 54-85%) at 3 months and 58% (95% CI: 41-74%) at 6 months. Determining the efficacy of combination therapy compared to single-agent therapy has immediate and important clinical implications. In this study, we will conduct a randomized, multicenter, controlled clinical trial evaluating the efficacy of combination therapy with varenicline and bupropion SR compared to varenicline and placebo in 506 cigarette smokers at the Mayo Clinic in Rochester, MN, and the University of Minnesota in Minneapolis, MN.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| varenicline and buproprion SR | Active comparator | Drug: Varenicline, Drug: bupropion SREveryone randomized to this arm will receive varenicline (up to 1mg bid) and bupropion SR (150 mg bid)for 12 weeks. They will be followed up by study for an additional 9 months post end of medication - for a total of 1 year study participation. Everyone will receive behavioral counseling for the full year. |
| varenicline and placebo | Placebo comparator | Drug: Varenicline, Drug: placeboEveryone randomized to this arm will receive varenicline (up to 1mg bid) and placebo (0 mg bid)for 12 weeks. They will be followed up by study for an additional 9 months post end of medication - for a total of 1 year study participation. Everyone will receive behavioral counseling for the full year. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Subject is at least 18 years of age;
- Subject has provide written informed consent;
- Subject is smoking greater than or equal to 10 cigarettes per day for at least 6 months;
- 3) Subject is able to complete all study visits 4) Subject is in good health as determined by the investigator 5) Subject has the ability to participate fully in all aspects of the study and keep scheduled appointments 6) Subject is motivated to stop smoking.
Key exclusion criteria (18 listed)
- Female and were pregnant, lactating or likely to become pregnant during the trial and not able nor willing to use contraception or had:
- an unstable medical condition;
- another household member participating in the study;
- bupropion or varenicline allergy;
- current use (previous 30 days) of a tobacco dependence treatment and unable or unwilling to discontinue use;
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 |
|---|---|---|
| VareniclineAlso: chantixvarenicline - 1 mg bid for 12 weeks | Drug | varenicline and buproprion SR, varenicline and placebo |
| placeboAlso: sugar pillplacebo for 12 weeks | Drug | varenicline and placebo |
| bupropion SRAlso: wellbutrin SR, zybanbupropion sr - 150 mg bid for 12 weeks | Drug | varenicline and buproprion SR |
Primary outcome
Prolonged Smoking Abstinence Rates at 12 Weeks in Cigarettes Smokers.
Time frame: 3 months
Prolonged smoking abstinence is defined as no smoking, not even a puff, in the last 7 days, and a negative response to the question "Since 2 weeks after your target quit date, have you smoked any tobacco, even a puff, for 7 consecutive days or at least once each week on 2 consecutive weeks?"
Point Prevalence Abstinence at 3 Months.
Time frame: 3 months
biochemically confirmed 7-day point prevalence abstinence defined as no smoking, not even a puff, in the previous 7 days.
5 secondary outcomes
Prolonged Smoking Abstinence Rates at 26 Weeks in Cigarettes Smokers.
Time frame: 6 months
Weight Gain From Baseline to 3 Months
Time frame: 3 months
Point Prevalence Abstinence at 6 Months.
Time frame: 6 months
Prolonged Abstinence at 12 Months
Time frame: 12 months
Point Prevalence Abstinence at 12 Months
Time frame: 12 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 May 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 24399554Ebbert JO, Hatsukami DK, Croghan IT, Schroeder DR, Allen SS, Hays JT, Hurt RD. Combination varenicline and bupropion SR for tobacco-dependence treatment in cigarette smokers: a randomized trial. JAMA. 2014 Jan 8;311(2):155-63. doi: 10.1001/jama.2013.283185.
- Derived from this study: PubMed 37142273Livingstone-Banks J, Fanshawe TR, Thomas KH, Theodoulou A, Hajizadeh A, Hartman L, Lindson N. Nicotine receptor partial agonists for smoking cessation. Cochrane Database Syst Rev. 2023 May 5;5(5):CD006103. doi: 10.1002/14651858.CD006103.pub8.
- Derived from this study: PubMed 34611902Hartmann-Boyce J, Theodoulou A, Farley A, Hajek P, Lycett D, Jones LL, Kudlek L, Heath L, Hajizadeh A, Schenkels M, Aveyard P. Interventions for preventing weight gain after smoking cessation. Cochrane Database Syst Rev. 2021 Oct 6;10(10):CD006219. doi: 10.1002/14651858.CD006219.pub4.
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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 Ebbet, MD principal investigator
Mayo Clinic
Dorothy Hatsukami, PhD study director
University of Minnesota
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Varenicline and bupropion SR in people with Smoking, run by Mayo Clinic at 3 sites 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 4 inclusion and 18 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 9 May 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 24 Apr 2014). 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?
Prolonged Smoking Abstinence Rates at 12 Weeks in Cigarettes Smokers. (time frame: 3 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00935818, which also lists 3 linked publications.
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 9 May 2014.