NCT06234722

Modeling Tobacco Regulatory Impacts in Appalachia Using the Experimental Tobacco Marketplace

• Status: Enrolling By Invitation
• Phase: N/A
• Study type: Interventional
• Enrollment: 473 (estimated)
• Sponsor: Mikhail N Koffarnus · Academic / Other
• Sex: All
• Age: 21 Years
• Healthy volunteers: Accepted

Summary

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.

Conditions

• Tobacco Use
• Cigarette Use

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2024-08-16
• Primary completion: 2028-02-01
• Completion: 2028-08-01
• First posted: 2024-01-31
• Last updated: 2024-08-19

Locations

1 site across 1 country: United States