Individualizing Pharmacotherapy for African American Smokers
Condition: Smoking Cessation
Intervention: Nicotine patch; Varenicline Tartrate; Bupropion
Intervention description: Participants will receive the 24-hour 21mg nicotine patch for up to 18 weeks of treatment.; VAR will be dispensed 0.5 mg once daily on Days 1-3, 0.5 mg twice daily on Days 4-7, and 1 mg twice daily from Day 8 through the end of treatment.; BUP will be dispensed 150 mg once daily on Days 0-3 and then 150 mg twice daily from Day 4 through optimization or the end of treatment.
Intervention MeSH terms: Bupropion; Nicotine; Varenicline
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: African American smokers randomized to OPT (n=196) will receive high intensity smoking cessation counseling, nicotine patch (NP), and up to two pharmacotherapy optimizations [varenicline (VAR), bupropion (BUP) plus NP] based on verified smoking status at Weeks 2 and 6.
African American smokers randomized to enhanced UC (n=196) will receive the same high intensity counseling and NP with no optimizations in pharmacotherapy.
Masking: None (Open Label)
Enrollment: 392.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      Improving cessation outcomes for African American smokers through the use of novel,
      empirically-based strategies is a national health priority. In the vast majority of smoking
      cessation studies and in clinical practice, when smokers are provided a medication to help
      them quit, they are expected to continue that medication regardless of how well it is
      working. This study will assess whether African Americans smokers respond better if they
      continue with a single treatment or if their treatment is changed when that treatment is not
      working.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Non-Hispanic African American

          -  ≥ 18 years of age

          -  Smoke 5-30 cigarettes per day (CPD)

          -  Daily cigarette smoker

          -  Smoked at current rate for > 6 months

          -  Verified smoker (CO > 5 ppm)

          -  Functioning telephone

          -  Interested in quitting smoking

          -  Willing to take NP, VAR , and/or BUP+NP for 18 weeks and complete all study visits

        Exclusion Criteria:

          -  Use of non-cigarette tobacco products in past 30 days

          -  Medical contraindications to NP, BUP, or VAR: unstable cardiac condition (e.g.,
             unstable angina or AMI) cardiac event, or stroke in the past 4 weeks; renal
             impairment; medications contraindicated ; history of clinically significant allergic
             reactions; history of epilepsy, seizure, head trauma, psychosis, bipolar disorder,
             eating disorder; unstable panic disorder or depression; active suicidal ideation;
             treatment for alcohol or drug dependence in the past year

          -  Use of pharmacotherapy in the month prior to enrollment

          -  Pregnant, contemplating getting pregnant, or breastfeeding

          -  Unstable housing (e.g., street, shelter)

          -  Plans to move from Kansas City during the treatment and follow-up phase

          -  Another household member enrolled in the study