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Combination Therapy With Varenicline and Bupropion for Smoking Cessation


Phase 2/Phase 3
18 Years
N/A
Not Enrolling
Both
Smoking

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Trial Information

Combination Therapy With Varenicline and Bupropion for Smoking Cessation


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.


Inclusion Criteria:



1. at least 18 years of age;

2. smoking greater than or equal to 10 cigarettes per day for at least 6 months;

3. motivated to stop smoking.

Exclusion Criteria:

1. an unstable medical condition;

2. unstable angina, myocardial infarction, or coronary angioplasty within the past 3
months or an untreated cardiac dysrhythmia;

3. a personal history of seizures;

4. a history of closed head trauma with any loss of consciousness or amnesia in the last
5 years;

5. a history of closed head trauma with greater than or equal to 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. current depression as assessed by Center for Epidemiologic Studies Depression
(CES-D);

8. active substance abuse other than nicotine;

9. used an investigational drug within the last 30 days;

10. current use of using a behavioral or pharmacologic tobacco treatment and unwilling or
unable to discontinue use;

11. current use of bupropion or varenicline in the previous 30 days;

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 greater than or equal to
180 or diastolic greater than or equal to 100;

15. another member of their household already participating in this study.

16. All female subjects of childbearing potential who have a positive pregnancy test or
refuse to use contraception during participation in the study.

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Outcome Measure:

To evaluate the efficacy of 12 weeks of combination therapy with varenicline and bupropion SR compared to varenicline alone for increasing the prolonged and point prevalence smoking abstinence rates at 12 weeks in cigarettes smokers.

Outcome Time Frame:

3 months

Safety Issue:

No

Principal Investigator

Jon Ebbet, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Mayo Clinic

Authority:

United States: Food and Drug Administration

Study ID:

09-003598

NCT ID:

NCT00935818

Start Date:

September 2009

Completion Date:

April 2013

Related Keywords:

  • Smoking
  • smoking
  • nicotine
  • tobacco
  • dependence
  • cessation
  • abstinence
  • Smoking

Name

Location

Mayo ClinicRochester, Minnesota  55905
University of MinnesotaMinneapolis, Minnesota  55455
Franciscan Skemp HospitalLaCrosse, Wisconsin  54601