Individualizing Pharmacotherapy for African American Smokers
Individualizing Pharmacotherapy for African American Smokers
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