Modeling Tobacco Regulatory Impacts in Appalachia Using the Experimental Tobacco Marketplace
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Very Low Nicotine Cigarette, Reduced nicotine regulatory environment, Restriction on characterizing flavors in combustible nicotine products, Restriction on characterizing flavors in noncombustible nicotine products.
- Who it may be relevant to
- Registry conditions: Tobacco Use, Cigarette Use. Basic parameters: from 21 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Detailed description
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.
Interventions
- Drug Very Low Nicotine Cigarette
Participants will be assigned to one of two investigational cigarette nicotine levels for the duration of the experiment: 0.4mg/g or 15.8mg/g - Behavioral Reduced nicotine regulatory environment
In this regulatory environment, participants' usual combustible cigarette will not be available in the Experimental Tobacco Marketplace and only the participants' assigned investigational cigarette will be the only available combustible cigarette. - Behavioral Restriction on characterizing flavors in combustible nicotine products
In this regulatory environment, menthol and other characterizing flavors in combustible nicotine products will not be available in the Experimental Tobacco Marketplace. Only tobacco or no flavored combustible nicotine products will be the only combustible nicotine products available. - Behavioral Restriction on characterizing flavors in noncombustible nicotine products
In this regulatory environment, menthol and other characterizing flavors in noncombustible nicotine products will not be available in the Experimental Tobacco Marketplace. Only tobacco or no flavored noncombustible nicotine products will be the only noncombustible nicotine products available.
Primary outcome measures
- Aggregate behavioral economic demand across all participants under the proposed regulatory environments [Time frame: Assessed at study week 0 and at study week 9]
- Aggregate behavioral economic substitution across all participants under the proposed regulatory environments [Time frame: Assessed at study week 0 and at study week 9]
Secondary outcome measures (11)
- Timeline Follow-Back (TLFB): Average of marijuana and nicotine use quantity [Time frame: Assessed at study week 0 and at study week 9]
- Fagerström Test for Nicotine Dependence (FTND) [Time frame: Assessed at study week 0 and at study week 9]
- Minnesota Nicotine Withdrawal Scale (MNWS) [Time frame: Assessed at study week 0 and at study week 9]
- Hypothetical quantity purchased in purchase tasks [Time frame: Assessed at study week 0 and at study week 9]
- Delay Discounting Tasks [Time frame: Assessed at study week 0 and at study week 9]
- Activity Level Questionnaire - Substance Use Version (ALQ-SUV) [Time frame: Assessed at study week 0 and at study week 9]
- Breath Carbon Monoxide (CO) [Time frame: Collected twice daily through the 10 week duration of the study]
- Salivary Cotinine [Time frame: 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 [Time frame: Collected daily from study week 1 to study week 9]
- Self-reported withdrawal symptom severity [Time frame: Collected daily from study week 1 to study week 9]
- Self-reported nicotine craving intensity [Time frame: Collected daily from study week 1 to study week 9]
Eligibility criteria
Inclusion criteria
- 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
Exclusion criteria
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Crossover
- Masking
- Double blind
- Primary purpose
- Other
Study locations
United States · 1 center
- University of Kentucky — Lexington
Identifiers
NCT: NCT06234722 · 87440 · 1U54DA058256-01