Individualizing Pharmacotherapy for African American Smokers

Phase 3

Completed

Interventions: Drug: Nicotine patch
Drug: Varenicline Tartrate
Drug: Bupropion

Brief 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.

Detailed Description: 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.

Recruitment & Eligibility

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

Arm && Interventions

Group	Intervention	Description
Optimized Care (OPT)	Varenicline Tartrate	196 African American smokers will receive 12 weeks of smoking cessation counseling. They will receive the nicotine patch and up to two pharmacotherapy adaptations (VAR, BUP+NP) based on verified smoking status at Weeks 2 and 6 for a total of 18 weeks of pharmacotherapy.
Usual Care (UC)	Nicotine patch	196 African American smokers will receive 12 weeks of smoking cessation counseling and 18 weeks of nicotine patch.
Optimized Care (OPT)	Nicotine patch	196 African American smokers will receive 12 weeks of smoking cessation counseling. They will receive the nicotine patch and up to two pharmacotherapy adaptations (VAR, BUP+NP) based on verified smoking status at Weeks 2 and 6 for a total of 18 weeks of pharmacotherapy.
Optimized Care (OPT)	Bupropion	196 African American smokers will receive 12 weeks of smoking cessation counseling. They will receive the nicotine patch and up to two pharmacotherapy adaptations (VAR, BUP+NP) based on verified smoking status at Weeks 2 and 6 for a total of 18 weeks of pharmacotherapy.

Primary Outcome Measures

Name	Time	Method
Number of Participants With Biochemically Verified Smoking Abstinence at Week 12	Week 12	Biochemically verified 7-day point prevalence abstinence defined as smoking zero cigarettes at Week 12 visit. This will evaluate the short-term efficacy of optimized pharmacotherapy for smoking cessation in African American smokers.

Secondary Outcome Measures

Name	Time	Method
Number of Participants With Biochemically Verified Smoking Abstinence at Week 18	Week 18	Biochemically verified 7-day point prevalence abstinence defined as smoking zero cigarettes at Week 18 visit. This will evaluate the end-of-treatment efficacy of optimized pharmacotherapy for smoking cessation in African American smokers
Number of Participants With Biochemically Verified Smoking Abstinence at Week 26	Week 26	Biochemically verified 7-day point prevalence abstinence defined as smoking zero cigarettes at Week 26 visit. This will evaluate the long-term efficacy of optimized pharmacotherapy for smoking cessation in African American smokers