Internet-Administered Smoking Cessation Treatment for Overweight and Obese Smokers
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 54
- 试验地点
- 1
- 主要终点
- Number of Participants With Verified Smoking Cessation (Abstinence)
研究概览
简要总结
This project will be a randomized clinical trial testing the efficacy of an internet-administered smoking cessation treatment for overweight and obese smokers. Research on internet-administered behavioral treatments for smoking cessation has found that compared to control treatments (e.g., self-help materials), cessation rates in internet-administered treatments are significantly higher. Research testing the applicability of these treatments to overweight and obese individuals has not yet been conducted. Given that a substantial portion of smokers are also overweight and at elevated cardiovascular risk, there is a need for directed treatment efforts for this group. The current trial proposes to be the first to test the effectiveness of internet-administered smoking cessation treatment for overweight and obese (BMI≥25) smokers. Adult participants will be randomized to receive 12 weeks of internet-administered treatment consisting of either: a) standard smoking cessation treatment with general health education, or b) standard smoking cessation treatment with cognitive behavioral therapy (CBT) for weight concerns. Participants in both conditions will receive open-label treatment with the 21 mg transdermal nicotine patch.
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
- 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
- 否
入选标准
- •Smoking 10 or more cigarettes per day
- •Regular access to the internet
排除标准
- •Type I diabetes or Type II diabetes requiring medication
- •Alcohol or drug dependence within the past year
- •Females with current pregnancy or breastfeeding or intention to become pregnant within the next 12 months
- •Uncontrolled hypertension
- •Severe chronic obstructive pulmonary disease
- •Use of an investigational drug within 30 days or current participation in another clinical trial
- •Current use of tobacco products other than cigarettes or use of marijuana
- •Use of nicotine replacement therapy, clonidine, varenicline, bupropion, or nortriptyline within the month prior to enrollment
- •Use of a medication that might affect weight or appetite
- •History of allergic reactions to adhesives.
研究组 & 干预措施
Health Education + Nicotine Patch
Health Education + Nicotine Replacement Patch
干预措施: Nicotine patch (Drug)
Cognitive Behavioral + Nicotine Patch
Cognitive Behavioral Therapy + Nicotine Replacement Patch
干预措施: Nicotine patch (Drug)
结局指标
主要结局
Number of Participants With Verified Smoking Cessation (Abstinence)
时间窗: Post-treatment (12-weeks)
Continuous abstinence during the last 14 days of treatment, confirmed by biologically verified abstinence (CO level \<10ppm)
次要结局
- Percent Weight Change(Post-treatment (12 weeks))
研究者
Marney A. White
Associate Professor of Psychiatry
Yale University