The Impact of Cigarette Nicotine Content, E-Cigarette Nicotine Content and E-Cigarette Flavoring on Smoking Behavior in an Electronic Tobacco Marketplace
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 69
- 试验地点
- 2
- 主要终点
- Number of Cigarettes Purchased
研究概览
简要总结
This study is proposing a four condition Electronic Tobacco Marketplace (ETM) study to determine if banning normal nicotine content (NNC) is sufficient for encouraging smokers to switch to potentially less harmful products or if the availability of higher nicotine and/or flavored alternative products (specifically e-cigarettes) are needed to achieve maximal reductions in smoking.
详细描述
The Family Smoking Prevention and Tobacco Control Act (FSPTCA) passed in 2009 provides the FDA with the authority to regulate tobacco products. One provision in this legislative act empowers the FDA to set limits on constituents in tobacco products, including nicotine. Such a measure has the potential to reduce the chance of individuals experimenting with smoking from becoming dependent and enable current smokers to quit when they are motivated to do so. Although the proposal to reduce nicotine in cigarettes has been met with skepticism by some because of concerns over compensatory smoking behavior and the potential emergence of a black market, this policy measure was considered to be technically feasible by the American Medical Association and the British Medical, by tobacco control researchers, policymakers and governmental officials who were convened in a meeting on nicotine regulation8, and by the World Health Organization Study Group on Tobacco Product Regulation. Most importantly, in July 2017, FDA Commissioner Gottlieb announced he was "directing our Center for Tobacco Products to develop a comprehensive nicotine regulatory plan premised on the need to confront and alter cigarette addiction." This announcement was followed on March 16, 2018 by the release of the Advance Notice of Proposed Rulemaking entitled "Tobacco Product Standard for Nicotine Level of Combusted Cigarettes" (ID: FDA-2017-N-6189-0001) "to obtain information for consideration in developing a tobacco product standard to set the maximum nicotine level for cigarettes."
This study proposes to conduct a within-subjects, multi-session virtual lab study and validation field assessment to determine how the availability of flavored e-liquids affects product purchasing among cigarette smokers. Adult daily cigarette smokers (N=64) will be recruited for this study. After initial eligibility is assessed, participants will complete six virtual sessions (1 baseline, 4 experimental, and 1 follow-up) and one field assessment to evaluate their tobacco use.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Health Services Research
- 盲法
- Single (Participant)
盲法说明
Participants are told their shopping trips are randomly selected, when they are actually being randomly selected between the two marketplace groups where only one flavor of e-liquid is available.
入排标准
- 年龄范围
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •21+ years of age
- •Self-report smoking at least 5 cigarettes per day for the past year
- •Breathe carbon monoxide (CO) level > 8 ppm or positive urine NicCheck
- •Willingness to use other tobacco products during the study
- •Speak, comprehend, and read English sufficiently to complete study procedures
- •Have home access to a computer, smart phone, or tablet with a web camera and internet access
- •Tried a vaping device at least once in their lifetime
排除标准
- •Currently seeking treatment to quit smoking
- •Self-reported serious medical or psychiatric condition(s) including cardiovascular and chronic respiratory diseases
- •Body temperature > 100.4 F
- •Cold, flu or COVID-19 symptoms including fever, cough, and runny nose in the past 30 days
- •Currently pregnant, breastfeeding or intending to become pregnant for the duration of the study or unwilling to agree to use adequate protection to avoid pregnancy
- •CO reading > 80 ppm
结局指标
主要结局
Number of Cigarettes Purchased
时间窗: Visit 6 approximately 4 weeks after baseline
Average number of cigarettes purchased (analyzed as raw data and using derived behavioral economic measures)
次要结局
- Number of E-liquid Milliliters Purchased(Visit 6 approximately 4 weeks after baseline)
- Proportion of Participants Completing Flavor and Nicotine Content Discrete Choice Projections(Month 1 after baseline)
- Lung Cancer Perceived Risk Scores for VLNC Cigarettes(Baseline)
- Product Evaluation Scale Scores(Visit 6 approximately 4 weeks after baseline)
- Minnesota Nicotine Withdrawal Scale Scores(Visit 6 approximately 4 weeks after baseline)
- Questionnaire on Smoking Urges Score(Visit 6 approximately 4 weeks after baseline)
- Tobacco Product Interest Scores(1 month after baseline)
- Tobacco Policy Questionnaire Scores(1 month after baseline)