Modeling Tobacco Regulatory Impacts in Appalachia Using the Experimental Tobacco Marketplace
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 发起方
- 入组人数
- 473
- 试验地点
- 1
- 主要终点
- Aggregate behavioral economic demand across all participants under the proposed regulatory environments
研究概览
简要总结
The goal of this project is to look at the effect of proposed tobacco product regulations in Appalachian Kentucky. Appalachian Kentucky is a diverse and underserved rural area that would benefit from more tobacco regulation research. Researchers will study the effects of three proposed tobacco product regulations among users of tobacco products in Appalachian KY. Researchers will also study how degree of rurality effects how those regulations impact behavior. Participants will be asked to complete online surveys and tests, online shopping sessions in a simulated Experimental Tobacco Marketplace, and track their tobacco product use throughout the 9-week experiment.
详细描述
After granting informed consent, participants will complete a baseline assessment session. This will be followed by an extended 9-week sampling period to acclimate participants to their randomly assigned experimental cigarette and allow any shifts in product consumption patterns to materialize. In the final week of this sampling period, participants will complete behavioral assessments and a series of assessments to assess the impact of potential regulatory environments relevant to our aims.
Experimental Tobacco Marketplace. In this procedure, participants will complete purchasing scenarios in our realistic tobacco/nicotine product marketplace to model and examine the impact of each of the proposed tobacco product regulations. Participants will be seated in front of a computer to access an online marketplace with an interface similar to many online merchants. This will allow participants to browse through the selection of products and add as many as they desire of each product to the virtual shopping cart. Each product will have the price clearly displayed along with an image and description of the product. The selection of products will vary based on the particular regulatory scenario that is being modeled. Tobacco and nicotine products will match the products found by surveying product availability vendors in the local communities. In each pricing scenario during each marketplace session, participants will be asked to make nicotine-product purchases sufficient for one week's use from this marketplace. During a purchasing session, the participant will be provided with a virtual budget that matches their actual weekly budget for nicotine/tobacco products, a procedure we have shown to generate realistic results. They will use that virtual budget to indicate which selection of products they would purchase from those available in the marketplace.
Baseline Assessment Session. The first experimental session will be an assessment session to collect information from participants on substance use patterns and addiction severity, as well as the results of behavioral and cognitive tasks that have measure components of our behavioral economic model of product valuation.
Sampling Period. After their assessment session, participants will be given a supply of their randomly assigned reduced-nicotine cigarette corresponding to two weeks of their typical cigarette consumption and asked to use the provided cigarettes as their only combusted tobacco product for 9 consecutive weeks.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Other
- 盲法
- Double (Participant, Investigator)
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
- •At least 21 years old
- •Consume nicotine and/or tobacco products daily
- •Have no plans to quit nicotine/tobacco consumption or seek treatment in the subsequent 9 weeks
- •Read and understand English
排除标准
- 未提供
研究组 & 干预措施
Rural - Conventional Cigarette
Participants who reside in rural locales of Appalachian KY and receive conventional cigarettes during the sampling period.
干预措施: Reduced nicotine regulatory environment (Behavioral)
Rural - Conventional Cigarette
Participants who reside in rural locales of Appalachian KY and receive conventional cigarettes during the sampling period.
干预措施: Restriction on characterizing flavors in combustible nicotine products (Behavioral)
Rural - Conventional Cigarette
Participants who reside in rural locales of Appalachian KY and receive conventional cigarettes during the sampling period.
干预措施: Restriction on characterizing flavors in noncombustible nicotine products (Behavioral)
Peri-Urban - Conventional Cigarette
Participants who reside in peri-urban locales of Appalachian KY and receive conventional cigarettes during the sampling period.
干预措施: Reduced nicotine regulatory environment (Behavioral)
Peri-Urban - Conventional Cigarette
Participants who reside in peri-urban locales of Appalachian KY and receive conventional cigarettes during the sampling period.
干预措施: Restriction on characterizing flavors in combustible nicotine products (Behavioral)
Peri-Urban - Conventional Cigarette
Participants who reside in peri-urban locales of Appalachian KY and receive conventional cigarettes during the sampling period.
干预措施: Restriction on characterizing flavors in noncombustible nicotine products (Behavioral)
Peri-Urban - Very Low Nicotine Cigarette
Participants who reside in peri-urban locales of Appalachian KY and receive very low nicotine cigarettes during the sampling period.
干预措施: Very Low Nicotine Cigarette (Drug)
Peri-Urban - Very Low Nicotine Cigarette
Participants who reside in peri-urban locales of Appalachian KY and receive very low nicotine cigarettes during the sampling period.
干预措施: Reduced nicotine regulatory environment (Behavioral)
Peri-Urban - Very Low Nicotine Cigarette
Participants who reside in peri-urban locales of Appalachian KY and receive very low nicotine cigarettes during the sampling period.
干预措施: Restriction on characterizing flavors in combustible nicotine products (Behavioral)
Peri-Urban - Very Low Nicotine Cigarette
Participants who reside in peri-urban locales of Appalachian KY and receive very low nicotine cigarettes during the sampling period.
干预措施: Restriction on characterizing flavors in noncombustible nicotine products (Behavioral)
Rural - Very Low Nicotine Cigarette
Participants who reside in rural locales of Appalachian KY and receive very low nicotine cigarettes during the sampling period.
干预措施: Very Low Nicotine Cigarette (Drug)
Rural - Very Low Nicotine Cigarette
Participants who reside in rural locales of Appalachian KY and receive very low nicotine cigarettes during the sampling period.
干预措施: Reduced nicotine regulatory environment (Behavioral)
Rural - Very Low Nicotine Cigarette
Participants who reside in rural locales of Appalachian KY and receive very low nicotine cigarettes during the sampling period.
干预措施: Restriction on characterizing flavors in combustible nicotine products (Behavioral)
Rural - Very Low Nicotine Cigarette
Participants who reside in rural locales of Appalachian KY and receive very low nicotine cigarettes during the sampling period.
干预措施: Restriction on characterizing flavors in noncombustible nicotine products (Behavioral)
结局指标
主要结局
Aggregate behavioral economic demand across all participants under the proposed regulatory environments
时间窗: Assessed at study week 0 and at study week 9
Participants will complete trials of the Experimental Tobacco Marketplace wherein the price of a target commodity will be increased. Nonlinear mixed effects modeling will be used to fit a curve to estimate the number of products purchased at each price and the analysis will result in an measure of overall price sensitivity under each of the regulatory conditions.
Aggregate behavioral economic substitution across all participants under the proposed regulatory environments
时间窗: Assessed at study week 0 and at study week 9
Participants will complete trials of the Experimental Tobacco Marketplace wherein the price of alternative products will be fixed across trials and their usual product will change price. Mixed effects modeling will be used to fit a curve to estimate the slopes and intercepts of these alternative products, revealing the degree to which participants will choose to purchase each alternative product as the price of the participant's usual product increases.
次要结局
- Activity Level Questionnaire - Substance Use Version (ALQ-SUV)(Assessed at study week 0 and at study week 9)
- Minnesota Nicotine Withdrawal Scale (MNWS)(Assessed at study week 0 and at study week 9)
- Self-reported withdrawal symptom severity(Collected daily from study week 1 to study week 9)
- Timeline Follow-Back (TLFB): Average of marijuana and nicotine use quantity(Assessed at study week 0 and at study week 9)
- Fagerström Test for Nicotine Dependence (FTND)(Assessed at study week 0 and at study week 9)
- Breath Carbon Monoxide (CO)(Collected twice daily through the 10 week duration of the study)
- Salivary Cotinine(Collected with assessment sessions at study weeks 0 and 9, as well as twice weekly remotely during interim sampling period)
- Self-reported nicotine product use(Collected daily from study week 1 to study week 9)
- Self-reported nicotine craving intensity(Collected daily from study week 1 to study week 9)
- Hypothetical quantity purchased in purchase tasks(Assessed at study week 0 and at study week 9)
- Delay Discounting Tasks(Assessed at study week 0 and at study week 9)
研究者
Mikhail N Koffarnus
Associate Professor
University of Kentucky
