Modeling Tobacco Regulatory Impacts in Appalachia Using the Experimental Tobacco Marketplace
NCT ID: NCT06234722
Last Updated: 2024-08-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ENROLLING_BY_INVITATION
NA
473 participants
INTERVENTIONAL
2024-08-16
2028-08-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
CROSSOVER
OTHER
DOUBLE
Study Groups
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Rural - Conventional Cigarette
Participants who reside in rural locales of Appalachian KY and receive conventional cigarettes during the sampling period.
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.
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.
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.
Peri-Urban - Conventional Cigarette
Participants who reside in peri-urban locales of Appalachian KY and receive conventional cigarettes during the sampling period.
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.
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.
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.
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.
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
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.
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.
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.
Rural - Very Low Nicotine Cigarette
Participants who reside in rural locales of Appalachian KY and receive very low nicotine cigarettes during the sampling period.
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
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.
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.
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.
Interventions
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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
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.
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.
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.
Eligibility Criteria
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Inclusion Criteria
* 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
21 Years
ALL
Yes
Sponsors
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National Institute on Drug Abuse (NIDA)
NIH
Mikhail N Koffarnus
OTHER
Responsible Party
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Mikhail N Koffarnus
Associate Professor
Locations
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University of Kentucky
Lexington, Kentucky, United States
Countries
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Other Identifiers
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87440
Identifier Type: -
Identifier Source: org_study_id
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