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| ID | Type | Description | Link |
|---|---|---|---|
| 5U54DA058256-02 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute on Drug Abuse (NIDA) | NIH |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Qualtrics and Experimental Tobacco Marketplace | Experimental | Participants who report using cigarettes/e-cigarettes will complete a Qualtrics survey consisting of various decision-making tasks, novel hypothetical nicotine product demand tasks, and Experimental Tobacco Marketplace scenarios (ETM). There will be three total ETM scenarios, cigarette adjusting price, e-cigarette adjusting price, and both e-cigarette and cigarette adjusting price. |
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| Qualtrics Only | Experimental | Participants who do not report using cigarettes/e-cigarettes will complete will complete a Qualtrics survey consisting of various decision-making tasks, and novel hypothetical nicotine product demand tasks |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Experimental Tobacco Marketplace | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Demand Intensity and Price Sensitivity for Hypothetical Nicotine Products | Likelihood to purchase and consume hypothetical nicotine products and sensitivity to cost of different product categories, flavors, and nicotine combinations will be assessed in all groups. Hypothetical demand will be assessed using non-linear mixed-effects modeling to obtain estimates of demand intensity and price sensitivity for these hypothetical products. Higher intensity and lower price sensitivity are indicators for higher subjective value and likelihood to try these novel products. | Assessed at study week 0 |
| Alternative Product Purchasing as a Function of Change in Price of Cigarettes and/or E-Cigarettes in the Experimental Tobacco Marketplace | Cigarette and e-cigarette users will complete different experimental tobacco marketplace scenarios. Alternative product purchasing (substitution) for different nicotine products as a function of increasing price of cigarettes/e-cigarettes will be measured with non-linear mixed-effects cross-commodity demand equations that determine the magnitude and direction of product substitution as a function of price increases of cigarettes and/or e-cigarettes. A higher magnitude indicates a larger change in product purchasing as a function of the ascending price item, where direction determines if the commodity was a complement to or substitute of the ascending price item(s). In the case of failures of non-linear model fitting, linear models will be used to determine product substitution based on intercept (initial purchasing) and slope (degree of substitution). | Assessed at study week 0 |
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Cigarette/E-Cigarette Users
Inclusion Criteria:
Cigarette/E-Cigarette Non-Users
Inclusion Criteria:
Risky Alcohol Users
Inclusion Criteria:
Non-Risky Alcohol Users
Inclusion Criteria:
All groups
Inclusion Criteria:
Exclusion Critera:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Kentucky | Lexington | Kentucky | 40506 | United States |
Deidentified data from this study will be made as available as possible after acceptance for publication. All shared data will comply with HIPAA guidelines on personally identifiable information. Code used for analyses will also accompany deidentified data.
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| ICF | No | No | Yes | Informed Consent Form | Aug 14, 2025 | Sep 15, 2025 | ICF_000.pdf |
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| ID | Term |
|---|---|
| D000428 | Alcohol Drinking |
| D000072137 | Vaping |
| ID | Term |
|---|---|
| D004327 | Drinking Behavior |
| D001519 | Behavior |
| D012907 | Smoking |
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| Hypothetical Novel Nicotine Product Purchase Tasks | Behavioral | 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. |
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