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.

The objective of this study is to examine the efficacy of optimized (OPT) versus enhanced usual care (UC) treatment for smoking cessation. 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. Pharmacotherapy and counseling in both groups will last for 18 weeks with long-term follow-up through Week 26. The primary outcome is biochemically-verified smoking status at Week 12.

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

Adverse event data was collected through Week 18.

Adverse event data was collected at each follow-up timepoint with a series of global side effect questions and a prompt to report an adverse events. Events are reported by group, overall (OPT, UC) , and not per intervention within group (e.g., optimized care: NP, optimized care: VAR, optimized care: BUP + NP) because many participants in OPT received all interventions and it is not possible to separate the adverse events they experienced during each of the interventions they received.