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Varenicline and Bupropion for Smoking Cessation (CHANBAN)

This study has been completed.
Sponsor:
Collaborators:
University of Minnesota - Clinical and Translational Science Institute
Information provided by (Responsible Party):
Jon Ebbert, Mayo Clinic
ClinicalTrials.gov Identifier:
NCT00935818
First received: July 6, 2009
Last updated: April 25, 2014
Last verified: April 2014
  Purpose

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.


Condition Intervention Phase
Smoking
Drug: Varenicline
Drug: placebo
Drug: bupropion SR
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Combination Therapy With Varenicline and Bupropion for Smoking Cessation

Resource links provided by NLM:


Further study details as provided by Mayo Clinic:

Primary Outcome Measures:
  • Prolonged Smoking Abstinence Rates at 12 Weeks in Cigarettes Smokers. [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    biochemically confirmed 7-day point prevalence abstinence defined as no smoking, not even a puff, in the previous 7 days.


Secondary Outcome Measures:
  • Prolonged Smoking Abstinence Rates at 26 Weeks in Cigarettes Smokers. [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Weight Gain From Baseline to 3 Months [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    Weight change from baseline to three months in those who met criteria for prolonged abstinence at the 3 month visit

  • Point Prevalence Abstinence at 6 Months. [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Biochemically confirmed abstinence as no smoking, even a puff, for the prior 7 days.

  • Prolonged Abstinence at 12 Months [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Point Prevalence Abstinence at 12 Months [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Biochemically confirmed abstinence defined as no smoking, not even a puff, in the last 7 days


Enrollment: 506
Study Start Date: September 2009
Study Completion Date: April 2013
Primary Completion Date: April 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: varenicline and buproprion SR
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.
Drug: Varenicline
varenicline - 1 mg bid for 12 weeks
Other Name: chantix
Drug: bupropion SR
bupropion sr - 150 mg bid for 12 weeks
Other Names:
  • wellbutrin SR
  • zyban
Placebo Comparator: varenicline and placebo
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.
Drug: Varenicline
varenicline - 1 mg bid for 12 weeks
Other Name: chantix
Drug: placebo
placebo for 12 weeks
Other Name: sugar pill

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Subject is at least 18 years of age;
  2. Subject has provide written informed consent;
  3. 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.

Exclusion Criteria:

Female and were pregnant, lactating or likely to become pregnant during the trial and not able nor willing to use contraception or had:

  1. an unstable medical condition;
  2. another household member participating in the study;
  3. bupropion or varenicline allergy;
  4. current use (previous 30 days) of a tobacco dependence treatment and unable or unwilling to discontinue use;
  5. an unstable medical condition or unstable angina, myocardial infarction, or coronary angioplasty (past 3 months) or an untreated cardiac dysrhythmia;
  6. a history of renal failure or were on renal dialysis;
  7. a history of seizures;
  8. 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");
  9. a history of closed head trauma associated with > 30 minutes of loss of consciousness, amnesia, skull fracture, subdural hematoma, or brain contusion;
  10. a history or psychosis, bipolar disorder, bulimia or anorexia nervosa;
  11. current moderate or severe depression as assessed by a score of ≥ 20 on the Beck Depression Inventory, Second Edition (BDI-II) 10;
  12. active substance abuse other than nicotine;
  13. current (past 14 days) use of an antipsychotic, monoamine oxidase inhibitors, or drugs known to interact with bupropion SR;
  14. a recent dose change of their antidepressant (within last 3 months);
  15. untreated hypertension or baseline systolic blood pressure > 180 or diastolic > 100;
  16. current treatment with another investigational drug for tobacco dependence (previous 30 days); or
  17. current use of bupropion or varenicline (previous 30 days).
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00935818

Locations
United States, Minnesota
University Of Minnesota
Minneapolis, Minnesota, United States, 55414
Mayo Clinic
Rochester, Minnesota, United States, 55905
United States, Wisconsin
Franciscan Skemp Hospital
LaCrosse, Wisconsin, United States, 54601
Sponsors and Collaborators
Mayo Clinic
University of Minnesota - Clinical and Translational Science Institute
Investigators
Principal Investigator: Jon Ebbet, MD Mayo Clinic
Study Director: Dorothy Hatsukami, PhD University of Minnesota - Clinical and Translational Science Institute
  More Information

Publications:
Responsible Party: Jon Ebbert, Principal Investigator, Mayo Clinic
ClinicalTrials.gov Identifier: NCT00935818     History of Changes
Other Study ID Numbers: 09-003598, 09-002459, 1RO1CA138417
Study First Received: July 6, 2009
Results First Received: March 21, 2014
Last Updated: April 25, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Mayo Clinic:
smoking
nicotine
tobacco
dependence
cessation
abstinence

Additional relevant MeSH terms:
Bupropion
Varenicline
Antidepressive Agents
Antidepressive Agents, Second-Generation
Central Nervous System Agents
Cholinergic Agents
Cholinergic Agonists
Dopamine Agents
Dopamine Uptake Inhibitors
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Neurotransmitter Uptake Inhibitors
Nicotinic Agonists
Pharmacologic Actions
Physiological Effects of Drugs
Psychotropic Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on November 25, 2014