Individualizing Pharmacotherapy for African American Smokers

Study Overview
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Brief Summary
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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
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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.

Official Title
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Individualizing Pharmacotherapy: A Novel Optimization Strategy to Increase Smoking Cessation in the African American Community

Conditions
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Smoking Cessation

Intervention / Treatment
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* Drug: Nicotine patch
* Drug: Varenicline Tartrate
* Drug: Bupropion


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Usual Care (UC)<br>196 African American smokers will receive 12 weeks of smoking cessation counseling and 18 weeks of nicotine patch. | Drug: Nicotine patch<br>* Participants will receive the 24-hour 21mg nicotine patch for up to 18 weeks of treatment.<br>* Other names: Nicoderm;|
| Experimental: Optimized Care (OPT)<br>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. | Drug: Nicotine patch<br>* Participants will receive the 24-hour 21mg nicotine patch for up to 18 weeks of treatment.<br>* Other names: Nicoderm;Drug: Varenicline Tartrate<br>* 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.<br>* Other names: Chantix;Drug: Bupropion<br>* 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.<br>* Other names: Wellbutrin;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With Biochemically Verified Smoking Abstinence at 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. | Week 12 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With Biochemically Verified Smoking Abstinence at 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 | Week 18 | 
| Number of Participants With Biochemically Verified Smoking Abstinence at 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 | Week 26 |