Health Education Counseling With or Without Bupropion in Helping African Americans Stop Smoking
- Conditions
- Bladder CancerEsophageal CancerHead and Neck CancerKidney CancerTobacco Use DisorderCervical CancerGastric CancerLeukemiaLiver CancerLung Cancer
- Interventions
- Behavioral: smoking cessation interventionGenetic: gene expression analysisGenetic: polymerase chain reactionOther: counseling interventionOther: educational interventionProcedure: psychosocial assessment and care
- Registration Number
- NCT00666978
- Lead Sponsor
- Lisa Sanderson Cox, PhD
- Brief Summary
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
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 540
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Health Education Arm gene expression analysis Subjects receive counseling intervention and take placebo. Bupropion Arm counseling intervention Subjects undergo smoking cessation intervention and take bupropion. Bupropion Arm smoking cessation intervention Subjects undergo smoking cessation intervention and take bupropion. Bupropion Arm bupropion hydrochloride Subjects undergo smoking cessation intervention and take bupropion. Bupropion Arm psychosocial assessment and care Subjects undergo smoking cessation intervention and take bupropion. Health Education Arm polymerase chain reaction Subjects receive counseling intervention and take placebo. Health Education Arm counseling intervention Subjects receive counseling intervention and take placebo. Health Education Arm educational intervention Subjects receive counseling intervention and take placebo. Bupropion Arm gene expression analysis Subjects undergo smoking cessation intervention and take bupropion. Bupropion Arm polymerase chain reaction Subjects undergo smoking cessation intervention and take bupropion. Bupropion Arm educational intervention Subjects undergo smoking cessation intervention and take bupropion. Health Education Arm smoking cessation intervention Subjects receive counseling intervention and take placebo. Health Education Arm psychosocial assessment and care Subjects receive counseling intervention and take placebo.
- Primary Outcome Measures
Name Time Method Number of Participants With Salivary Cotinine-verified Smoking Abstinence at 6 Months 6 months Salivary cotinine-verified smoking abstinence at 6 months. A cut point of 15 ng/ml was used to differentiate smokers from nonsmokers.
- Secondary Outcome Measures
Name Time Method Number of Slow and Fast Metabolizers by Metabolite Ratio Weeks 0 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.Number of Participants for Each CYP2B6 Allele Week 3 We genotyped CYP2B6 in 268 from the Bupropion arm as this polymorphism is related to bupropion metabolism.
Number of Slow and Fast Metabolizers by Genotype Week 0 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.
Trial Locations
- Locations (2)
Swope Health Central
🇺🇸Kansas City, Missouri, United States
Kansas Masonic Cancer Research Institute at the University of Kansas Medical Center
🇺🇸Kansas City, Kansas, United States