Determinants of Smoking Cessation Among Latinos
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Number of Participants With 24-Hour Smoking Abstinence (Week 3 Post Quit Day)
研究概览
简要总结
The goal of this study is to learn how neighborhood and individual factors affect the ability to stop smoking among Spanish-speaking Mexican American (MA) smokers who want to quit smoking.
详细描述
If you agree to take part in this study, you will receive treatment to help you quit smoking, including written self-help materials, counseling, and a supply of the nicotine patch for 4 weeks. Over the next 6 months, you will visit M. D. Anderson 5 times during this study. You will also be called 3 times for smoking cessation counseling during this study.
Study Visits:
First (Orientation) Visit You will be asked about your feelings and moods, as well as how many cigarettes you smoke. You will fill out questionnaires on a computer. The questionnaires will be about your mood, stress level, and smoking-related issues. They should take about 1 hour and 30 minutes to complete.
You will complete a breath test. For the breath test, you will blow into a tube that's attached to a machine that is used to estimate the amount of tobacco smoke that you inhale.
You will give two saliva samples at this visit. To collect the first saliva sample, you will place a piece of cotton in your mouth for 3 minutes. The saliva sample is used to check the amount of cotinine in the body. Cotinine is a chemical that is produced in your saliva when your body breaks down nicotine.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Current daily smoker who average >/= 5 cigarettes/day for the last year
- •Mexican-American (MA) Adults from the Houston-based MA Cohort Study and/or from the community
- •Age 18 to 65 years
- •Motivated to quit smoking in the next 30 days
- •Viable (working) telephone number and home address
- •Prefers to speak in Spanish
- •Register "8" or more on a carbon monoxide breath test
排除标准
- •Contraindication for nicotine patch use
- •Regular use of tobacco products other than cigarettes (cigars, pipes, smokeless tobacco)
- •Use of nicotine replacement therapy products or other smoking cessation medications, other than the nicotine patches supplied during the study
- •Pregnancy or lactation
- •Currently enrolled in a smoking cessation program
- •Participation in a smoking cessation program or study during the past 90 days
- •Another household member is enrolled in this protocol
- •Active substance abuse problem
研究组 & 干预措施
Smoking Cessation Treatment
Nicotine replacement therapy (NRT), self-help materials, + brief in-person and telephone counseling, all conducted in Spanish. Computerized questionnaires at each of 5 visits and will take 1 1/2 hours to complete each time.
干预措施: Nicotine Replacement Therapy (NRT) (Drug)
Smoking Cessation Treatment
Nicotine replacement therapy (NRT), self-help materials, + brief in-person and telephone counseling, all conducted in Spanish. Computerized questionnaires at each of 5 visits and will take 1 1/2 hours to complete each time.
干预措施: Questionnaire (Behavioral)
Smoking Cessation Treatment
Nicotine replacement therapy (NRT), self-help materials, + brief in-person and telephone counseling, all conducted in Spanish. Computerized questionnaires at each of 5 visits and will take 1 1/2 hours to complete each time.
干预措施: Counseling (Behavioral)
Smoking Cessation Treatment
Nicotine replacement therapy (NRT), self-help materials, + brief in-person and telephone counseling, all conducted in Spanish. Computerized questionnaires at each of 5 visits and will take 1 1/2 hours to complete each time.
干预措施: Self-Help Materials (Behavioral)
结局指标
主要结局
Number of Participants With 24-Hour Smoking Abstinence (Week 3 Post Quit Day)
时间窗: Week 3 post quit day
Biochemically verified 24-hour point prevalence abstinence rates based on a completers-only approach.
24-Hour Smoking Abstinence (Week 26 Post Quit Day)
时间窗: Week 26 post quit day
Biochemically verified 24-hour point prevalence abstinence rates based on a completers-only approach.
7-Day Smoking Abstinence (Week 3 Post Quit Day)
时间窗: Week 3 post quit day
Biochemically verified 7-day point prevalence abstinence rates based on a completers-only approach.
7-Day Smoking Abstinence (Week 26 Post Quit Day)
时间窗: Week 26 post quit day
Biochemically verified 7-day point prevalence abstinence rates based on a completers-only approach.
30-Day Smoking Abstinence (Week 26 Post Quit Day)
时间窗: Week 26 post quit day
Biochemically verified 30-day point prevalence abstinence rates based on a completers-only approach.
7-Day Smoking Abstinence (Week 3 Post Quit Day) Intent to Treat
时间窗: Week 3 post quit day
Biochemically verified 7-day point prevalence abstinence rates using an intent-to-treat approach
7-Day Smoking Abstinence (Week 26 Post Quit Day) Intent to Treat
时间窗: Week 26 post quit day
Biochemically verified 7-day point prevalence abstinence rates using an intent-to-treat approach
7-Day Smoking Abstinence (Week 3 Post Quit Day) Continuous Abstinence
时间窗: Week 3 post quit day
Biochemically verified 7-day point prevalence abstinence rates using a completers-only approach
7-Day Smoking Abstinence (Week 26 Post Quit Day) Continuous Abstinence
时间窗: Week 26 post quit day
Biochemically verified 7-day point prevalence abstinence rates using a completers-only approach
次要结局
未报告次要终点