Health Education Counseling With or Without Bupropion in Helping African Americans Stop Smoking

Study Overview
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Brief Summary
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RATIONALE: A stop-smoking plan that includes health education counseling and bupropion may help African-American smokers stop smoking. It is not yet known whether health education counseling is more effective with or without bupropion in helping African Americans stop smoking. PURPOSE: This clinical trial is studying health education counseling and bupropion to see how well they work compared with a placebo and health education counseling in helping African Americans smokers stop smoking.

Detailed Description
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OBJECTIVES: Primary To evaluate the efficacy of bupropion hydrochloride and health education counseling vs placebo and health education counseling for smoking cessation among African Americans who are light smokers. Secondary To characterize CYP2A6 activity in African Americans who are light smokers by evaluating phenotype (3'hydroxycotinine/cotinine ratio [3HC/COT]) and CYP2A6 genotype. To evaluate the relationship between CYP2A6 activity and smoking cessation outcomes. To evaluate CYP2A6 genetic polymorphisms associated with nicotine and cotinine metabolism in African Americans who are light smokers. To measure baseline cotinine and metabolite levels to evaluate the nicotine metabolism phenotype of 3HC/COT. To evaluate the relationship between nicotine metabolism phenotype of 3HC/COT and smoking cessation outcomes. To evaluate CYP2A6 genotype as a predictor of smoking cessation outcomes. Tertiary To characterize CYP2B6 activity in African Americans who are light smokers by evaluating phenotype and CYP2B6 genotype. To evaluate the relationship between CYP2B6 activity and smoking cessation outcomes. To measure steady state bupropion hydrochloride and metabolite levels to identify a bupropion metabolism phenotype. To evaluate the relationship between bupropion hydrochloride metabolism phenotype and smoking cessation outcomes. To evaluate the relationship between CYP2B6 genetic polymorphisms (genotype) and blood levels of bupropion hydrochloride and active metabolites (phenotype). To determine the effects of CYP2B6 genotype as predictors of smoking cessation outcomes. OUTLINE: Participants are randomized to one of two arms. Arm I: Participants receive oral bupropion hydrochloride once or twice daily in weeks 0-6. Participants also undergo 6 sessions of health education counseling conducted in person during clinic visits in weeks 0, 3, and 7 and via telephone in weeks 1, 5, and 16. The health education counseling sessions include providing information about the risks of continued smoking and the benefits of quitting, developing a quit plan, outlining a concrete quit day preparation plan, discussing strategies for successful quitting, building social support, reducing stress, recognizing and managing withdrawal and craving, overcoming barriers to abstinence, and using medication for smoking cessation. Participants receive Kick It at Swope: Stop Smoking Guide, a culturally-sensitive smoking cessation guide, to review with their study counselor during the first counseling session. Arm II: Participants receive an oral placebo once or twice daily in weeks 0-6. Participants also undergo health education counseling as in arm I. Participants complete baseline questionnaires about demographics, smoking history, and psychometrics, including the following: racial identity, depressive symptoms, alcohol use, stress, smoking consequences, social support, environmental influences of smoking, adherence to study medication, nicotine withdrawal, craving, and mood. Participants undergo serum sample collection in weeks 0 and 3. To standardize the time since the last cigarette, participants are asked to smoke one cigarette prior to serum sample collection in week 0. Samples are analyzed for nicotine metabolism phenotype and bupropion hydrochloride metabolism phenotype by liquid chromatography and mass spectrometry and CYP2A6 and CYP2B6 genotype by polymerase chain reaction and polymorphism analysis. Participants who self-report abstinence also undergo saliva sample collection in weeks 7 and 26 to measure cotinine levels to verify smoking status. After completion of study intervention, participants are followed at 6 months.

Official Title
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Enhancing Tobacco Use Treatment for African American Light Smokers

Conditions
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Bladder Cancer, Cervical Cancer, Esophageal Cancer, Gastric Cancer, Head and Neck Cancer, Kidney Cancer, Leukemia, Liver Cancer, Lung Cancer, Pancreatic Cancer, Tobacco Use Disorder

Intervention / Treatment
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* Behavioral: smoking cessation intervention
* Drug: bupropion hydrochloride
* Genetic: gene expression analysis
* Genetic: polymerase chain reaction
* Other: counseling intervention
* Other: educational intervention
* Procedure: psychosocial assessment and care


Participation Criteria
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Eligibility Criteria
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DISEASE CHARACTERISTICS: African American who has smoked ≤ 10 cigarettes per day for ≥ 2 years AND has smoked for ≥ 25 days within the past month Not a heavy smoker No other forms of tobacco within the past 30 days Must be interested in stopping smoking No other smoker in the household enrolled in this study PATIENT CHARACTERISTICS: Has a home address and a functioning telephone number Not planning to move from the Kansas City metro area within the next 12 months Not pregnant or nursing Negative pregnancy test No alcohol or substance abuse within the past year Not currently drinking ≥ 14 alcoholic drinks per week No binge drinking (5 or more drinks on one occasion) on at least two occasions within the past month No history of seizures or head trauma No history of bulimia or anorexia nervosa No myocardial infarction within the past 30 days No reported use of opiates, cocaine, or stimulants No diabetes requiring oral hypoglycemics or insulin PRIOR CONCURRENT THERAPY: More than 30 days since prior nicotine replacement therapy, fluoxetine, clonidine, buspirone, or doxepin No other concurrent medication that contains bupropion hydrochloride No concurrent psychoactive medications

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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No

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
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Bupropion Arm<br>Subjects undergo smoking cessation intervention and take bupropion. | Behavioral: smoking cessation intervention<br> <br> Drug: bupropion hydrochloride<br> <br> Genetic: gene expression analysis<br> <br> Genetic: polymerase chain reaction<br> <br> Other: counseling intervention<br> <br> Other: educational intervention<br> <br> Procedure: psychosocial assessment and care<br> <br> |
| Placebo Comparator: Health Education Arm<br>Subjects receive counseling intervention and take placebo. | Behavioral: smoking cessation intervention<br> <br> Genetic: gene expression analysis<br> <br> Genetic: polymerase chain reaction<br> <br> Other: counseling intervention<br> <br> Other: educational intervention<br> <br> Procedure: psychosocial assessment and care<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With Salivary Cotinine-verified Smoking Abstinence at 6 Months | Salivary cotinine-verified smoking abstinence at 6 months. A cut point of 15 ng/ml was used to differentiate smokers from nonsmokers. | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Slow and Fast Metabolizers by Metabolite Ratio | Analyzed CYP2A6 by activity, called the nicotine metabolite ratio using a split between slow and fast metabolism at 0.31. The variants present in people in the slow genotype group include *17, *20, *23,*27, *35, *9, *2, *25, *26, and *4. The fast metabolizers have none of the variant alleles tested. Blood samples were collected for 3HC/COT ratio at Week 0. | Weeks 0 | 
| Number of Participants for Each CYP2B6 Allele | We genotyped CYP2B6 in 268 from the Bupropion arm as this polymorphism is related to bupropion metabolism. | Week 3 | 
| Number of Slow and Fast Metabolizers by Genotype | Analyzed CYP2A6 by genotype. The variants present in people in the slow genotype group include *17, *20, *23,*27, *35, *9, *2, *25, *26, and *4. The fast metabolizers have none of the variant alleles tested. Slow metabolizers have any reduction or loss of function variant. Fast metabolizers are *1/*1 genotype by exclusion. | Week 0 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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bladder cancer, cervical cancer, esophageal cancer, gastric cancer, renal cell carcinoma, adult primary liver cancer, non-small cell lung cancer, small cell lung cancer, pancreatic cancer, hypopharyngeal cancer, laryngeal cancer, lip and oral cavity cancer, nasopharyngeal cancer, oropharyngeal cancer, paranasal sinus and nasal cavity cancer, adult acute myeloid leukemia, tobacco use disorder