Combining Varenicline and Bupropion for Smoking Cessation
Condition: Smoking Cessation
Intervention: Varenicline; Bupropion; Placebo; Counseling/Phone Calls
Intervention description: On Days 1-3, .5mg tablet by mouth in the morning. Beginning on Day 4, and then every day after that, .5mg tablet by mouth in the morning and .5mg tablet by mouth in the evening (for a total of 2 doses).; On Days 1-3, 150 mg tablet by mouth in the morning. Beginning on Day 4, and then every day after that, 150 mg tablet by mouth in the morning and 150 mg tablet by mouth in the evening (for a total of 2 doses).; On Days 1-3, 1 tablet by mouth of placebo that looks like the study drug in the morning. Beginning on Day 4, and then every day after that, 1 tablet by mouth in the morning and 1 tablet by mouth in the evening for a total of 2 doses of the placebo each day.; Brief-behavioral counseling sessions (10-15 minutes) provided to all participants once per week for 12 weeks. One support phone call conducted 3 days after the target quit date.
Intervention MeSH terms: Bupropion; Varenicline
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 641.0
Sex: All
Minimum age: 25 Years
Maximum age: 70 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Smoking Cessation; Nicotine Withdrawal; Smoking Reduction; Varenicline; Chantix; Bupropion; Zyban

Summary:

      The goal of this clinical research study is learn if the combination of Chantix (varenicline)
      and Zyban (bupropion) is more effective at helping people to quit smoking than varenicline
      when given alone. Researchers also want to learn if this drug combination can reduce cravings
      and other negative symptoms of nicotine withdrawal better than varenicline does alone. The
      safety of this drug combination will also be tested.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Age: 25-70 years old

          2. Smoking 5 or more cigarettes per day, on average, within the 2 months preceding the
             screening visit and expired CO of greater than or equal to 6ppm.

          3. Able to follow verbal and written instructions in English and complete all aspects of
             the study

          4. Provide informed consent and agree to all assessments and study procedures

          5. Have an address and home telephone number where they may be reached

          6. Be the only participant in their household

        Exclusion Criteria:

          1. Within the month immediately preceding the screening visit, use of any form of tobacco
             products other than cigarettes on 3 or more days within a week if the individual
             refuses to refrain from such tobacco use during the course of the study.

          2. Within the month immediately preceding the screening visit, use of marijuana in any
             form on 3 or more days within a week

          3. Within the two weeks immediately preceding the screening visit, involvement on more
             than 3 days in any formal smoking cessation activities

          4. Treatment on a continuous basis within 2 weeks before the screening visit: any
             contraindicated medication for Varenicline or Bupropion. Classes of contraindicated
             medications include, but are not limited to, antiasthmatics, antipsychotics, some
             antidepressants, antihypertensives, antiarrhythmics, antineoplastics, some
             antiseizures, and MAO inhibitors (See Appendix U for specific list of excluded and
             precautionary medications).

          5. Uncontrolled hypertension (average reading of systolic blood pressure greater than 150
             or diastolic blood pressure greater than 95) or other major contraindications for
             Bupropion or Varenicline (See section on Screening).

          6. Severe renal impairment (Creatinine Clearance less than 30 ml/min/1.73 m2).

          7. Laboratory evaluations outside normal limits and of potential clinical significance in
             the opinion of the investigator.

          8. Meet current criteria for psychiatric disorders or substance abuse as assessed by the
             MINI plus (major depressive episode) and the MINI for items B, D, I, J (Alcohol
             Addendum-past 6 months only), K, L, M and N including a past manic or hypomanic
             episode as well as a lifetime psychotic disorder.

          9. Individuals rated as moderate (6 - 9) to high (10 or greater) on suicidality as
             assessed by Module C of the MINI.

         10. Psychiatric hospitalization within 1 year of screening date.

         11. A positive urine pregnancy test during the screening period. Women who are two years
             post menopausal, or who have had a tubal ligation or a partial or full hysterectomy
             will not be subject to a urine pregnancy test.

         12. Pregnant, breast-feeding or of childbearing potential and is not protected by a
             medically acceptable, effective method of birth control while enrolled in the study.
             Medically acceptable contraceptives include: (1) approved hormonal contraceptives
             (such as birth control pills, patches, implants or injections), (2) barrier methods
             (such as a condom or diaphragm) used with a spermicide, or (3) an intrauterine device
             (IUD). Contraceptive measures sold for emergency use after unprotected sex, are not
             acceptable methods for routine use.

         13. Use of Varenicline or Bupropion within two weeks before the screening visit.

         14. History of hypersensitivity or allergic reaction to Varenicline, tricyclic
             antidepressant, Bupropion (Wellbutrin, Zyban) or similar chemical classes or any
             component of these formulations.

         15. Current or previous history of a seizure disorder.

         16. Current or previous history of anorexia.

         17. Subject considered by the investigator as unsuitable candidate for receipt of an
             investigational drug or unstable to be followed up throughout the entire duration of
             the study.