Varenicline and Bupropion for Smoking Cessation

Last updated: April 25, 2014
Sponsor: Mayo Clinic
Overall Status: Completed

Phase

2/3

Condition

N/A

Treatment

N/A

Clinical Study ID

NCT00935818
09-003598
1R01CA138417
09-002459
  • Ages > 18
  • All Genders
  • Accepts Healthy Volunteers

Study 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.

Eligibility Criteria

Inclusion

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 6months;

  1. Subject is able to complete all study visits 4) Subject is in good health as determinedby the investigator 5) Subject has the ability to participate fully in all aspects of thestudy and keep scheduled appointments 6) Subject is motivated to stop smoking.

Exclusion

Exclusion Criteria: Female and were pregnant, lactating or likely to become pregnant during the trial and notable 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 orunwilling to discontinue use;

  5. an unstable medical condition or unstable angina, myocardial infarction, or coronaryangioplasty (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), currentnon-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 resultof 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 BeckDepression 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 drugsknown 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).

Study Design

Total Participants: 506
Study Start date:
September 01, 2009
Estimated Completion Date:
April 30, 2013

Study 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.

Connect with a study center

  • University Of Minnesota

    Minneapolis, Minnesota 55414
    United States

    Site Not Available

  • Mayo Clinic

    Rochester, Minnesota 55905
    United States

    Site Not Available

  • Franciscan Skemp Hospital

    LaCrosse, Wisconsin 54601
    United States

    Site Not Available

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