Enhancing Tobacco Use Treatment for African American Light Smokers
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 540
- 试验地点
- 2
- 主要终点
- Number of Participants With Salivary Cotinine-verified Smoking Abstinence at 6 Months
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Health Education Arm
Subjects receive counseling intervention and take placebo.
干预措施: counseling intervention (Other)
Health Education Arm
Subjects receive counseling intervention and take placebo.
干预措施: polymerase chain reaction (Genetic)
Bupropion Arm
Subjects undergo smoking cessation intervention and take bupropion.
干预措施: smoking cessation intervention (Behavioral)
Bupropion Arm
Subjects undergo smoking cessation intervention and take bupropion.
干预措施: bupropion hydrochloride (Drug)
Bupropion Arm
Subjects undergo smoking cessation intervention and take bupropion.
干预措施: gene expression analysis (Genetic)
Bupropion Arm
Subjects undergo smoking cessation intervention and take bupropion.
干预措施: polymerase chain reaction (Genetic)
Bupropion Arm
Subjects undergo smoking cessation intervention and take bupropion.
干预措施: counseling intervention (Other)
Bupropion Arm
Subjects undergo smoking cessation intervention and take bupropion.
干预措施: educational intervention (Other)
Bupropion Arm
Subjects undergo smoking cessation intervention and take bupropion.
干预措施: psychosocial assessment and care (Procedure)
Health Education Arm
Subjects receive counseling intervention and take placebo.
干预措施: smoking cessation intervention (Behavioral)
Health Education Arm
Subjects receive counseling intervention and take placebo.
干预措施: gene expression analysis (Genetic)
Health Education Arm
Subjects receive counseling intervention and take placebo.
干预措施: educational intervention (Other)
Health Education Arm
Subjects receive counseling intervention and take placebo.
干预措施: psychosocial assessment and care (Procedure)
结局指标
主要结局
Number of Participants With Salivary Cotinine-verified Smoking Abstinence at 6 Months
时间窗: 6 months
Salivary cotinine-verified smoking abstinence at 6 months. A cut point of 15 ng/ml was used to differentiate smokers from nonsmokers.
次要结局
- Number of Slow and Fast Metabolizers by Metabolite Ratio(Weeks 0)
- Number of Participants for Each CYP2B6 Allele(Week 3)
- Number of Slow and Fast Metabolizers by Genotype(Week 0)
研究者
Lisa Sanderson Cox, PhD
Research Assistant Professor
University of Kansas Medical Center