NCT07010601

Tobacco Product Susceptibility and Substitutability by Rurality and Alcohol Use

U54 Pilot: Comparing Tobacco Product Susceptibility and Product Substitution by Relative Rurality and Alcohol Use

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 737 (actual)
• Sponsor: Mark J Rzeszutek, PhD · Academic / Other
• Sex: All
• Age: 21 Years
• Healthy volunteers: Accepted

Summary

A high priority research area for the Food and Drug Administration Center for Tobacco Products (FDA CTP) is determining who will start using tobacco products and who will stop using tobacco products. A population that has a disproportionately high amount of tobacco use are people living in rural areas. This indicates that some aspect of rurality is related to tobacco product susceptibility and decreased tobacco cessation rates. People in rural areas also typically have higher rates of alcohol use, which is also associated with higher tobacco use and decreased tobacco cessation rates. The purpose of this study is to (1) examine how rurality and alcohol use may affect susceptibility to existing and novel tobacco products and (2) examine how rurality and alcohol use may affect likelihood for tobacco users to substitute to tobacco cessation products. To accomplish this, the investigators will use behavioral economic measures to assess how people respond to novel tobacco products (high and low nicotine, flavored and unflavored), as well as use the experimental tobacco marketplace to determine how current users might switch to products associated with cessation. Because rurality is a spectrum, the investigators will be using an index of relative rurality (IRR) to better quantify how rurality and alcohol use affect these tobacco-related behaviors.

Conditions

• Alcohol Use
• E-cigarette Use
• Cigarette Use

Interventions

Type	Name	Description
BEHAVIORAL	Experimental Tobacco Marketplace	This study will have three different scenarios in the Experimental Tobacco Marketplace (ETM) for participants who reported being cigarette and/or e-cigarette users. These will consist of hypothetical purchase scenarios where a variety of different tobacco products are available to purchase. The three ETM scenarios will be adjusting price cigarettes, adjusting price e-cigarettes, and both adjusting price cigarettes and e-cigarettes.
BEHAVIORAL	Hypothetical Novel Nicotine Product Purchase Tasks	This study will have a set of hypothetical demand tasks for novel nicotine products. These tasks consist of different novel hypothetical products (combusted, oral, and vaporized) of differing nicotine content (high and low), and different flavors (preferred alcoholic flavor, no characterizing flavor) where likelihood to try is assessed at a variety of price points.

Timeline

• Start date: 2025-08-18
• Primary completion: 2025-08-20
• Completion: 2025-08-20
• First posted: 2025-06-08
• Last updated: 2025-09-23

Locations

1 site across 1 country: United States