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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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The goal of this project is to learn about the potential impact of tobacco regulations that could affect the availability of tobacco products among adults who smoke nondaily and daily. Nondaily smoking is increasingly common and tobacco regulation research should consider how FDA actions may impact this group. Participants will be asked to complete online surveys and tests, online shopping sessions in a simulated Experimental Tobacco Marketplace. Reactions and decisions of adults who smoke nondaily and daily will be compared.
After granting informed consent, participants will complete the single assessment.
First, investigators will collect information from participants on personal characteristics, substance use patterns and addiction severity, and behavioral and cognitive tasks that measure components of our behavioral economic model of product valuation.
Experimental Tobacco Marketplace. In this procedure, participants will complete purchasing scenarios in a 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 a simulated online tobacco marketplace with an interface similar to many online merchants. This will allow participants to browse through the selection of tobacco 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. 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 our team has shown to generate realistic results. Participants will use that virtual budget to indicate which selection of products they would purchase from those available in the marketplace.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Daily smoking | Experimental | Participants who smoke cigarettes every day |
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| Nondaily smoking | Experimental | Participants who smoke cigarettes some days but not every day in a month |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Reduced nicotine regulatory environment | Behavioral | In this regulatory environment, participants' usual combustible cigarette will not be available in the Experimental Tobacco Marketplace and reduced nicotine content cigarettes will be the only available combustible cigarette. |
| Measure | Description | Time Frame |
|---|---|---|
| Aggregate behavioral economic demand across all participants under the proposed regulatory environments | Participants will complete trials of the Experimental Tobacco Marketplace wherein the price of a target commodity will be increased. Nonlinear mixed effects modeling will be used to fit a curve to estimate the number of products purchased at each price and the analysis will result in an measure of overall price sensitivity under each of the regulatory conditions. | Baseline |
| Aggregate behavioral economic substitution across all participants under the proposed regulatory environments | Participants will complete trials of the Experimental Tobacco Marketplace wherein the price of alternative products will be fixed across trials and their usual product will change price. Mixed effects modeling will be used to fit a curve to estimate the slopes and intercepts of these alternative products, revealing the degree to which participants will choose to purchase each alternative product as the price of the participant's usual product increases. | Baseline |
| Measure | Description | Time Frame |
|---|---|---|
| Hypothetical quantity purchased in purchase tasks | Measures valuation by assessing hypothetical consumption across a price range and across the range of products used by participants in the past 60 days. | Baseline |
| Delay Discounting Tasks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Bethany Shorey Fennell, PhD | University of Kentucky | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Kentucky | Lexington | Kentucky | 40504 | United States |
Only deidentified data will be shared.
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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 18, 2023 | Sep 30, 2025 |
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Mixed crossover-factorial
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| Restriction on characterizing flavors in combustible nicotine products | Behavioral | In this regulatory environment, menthol and other characterizing flavors in combustible nicotine products will not be available in the Experimental Tobacco Marketplace. Tobacco- or no-flavored combustible nicotine products will be the only combustible nicotine products available. |
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| Restriction on characterizing flavors in noncombustible nicotine products | Behavioral | In this regulatory environment, menthol and other characterizing flavors in noncombustible nicotine products will not be available in the Experimental Tobacco Marketplace. Tobacco- or no-flavored noncombustible nicotine products will be the only noncombustible nicotine products available. |
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Assesses valuation for future money and nicotine products.
| Baseline |
| ICF_000.pdf |
| ID | Term |
|---|---|
| D064424 | Tobacco Use |
| ID | Term |
|---|---|
| D001519 | Behavior |
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