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| ID | Type | Description | Link |
|---|---|---|---|
| 5P01CA200512 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| Medical University of South Carolina | OTHER |
| National Cancer Institute (NCI) | NIH |
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This study will investigate the relative appeal (abuse liability) of novel tobacco products, how the appeal is modulated by relative price, user type, and how novel products may substitute for one another.
An important aim of tobacco control is to reduce demand for the most harmful products. Therefore, a priori knowledge of substitutability across novel and widely used tobacco products may forecast the impact of policies on product switching. This study will use a novel method, the Experimental Tobacco Marketplace (ETM), to characterize the relative substitutability and appeal (abuse liability) of tobacco products (e.g., conventional cigarettes, nicotine vaping products [NVP], heated tobacco products [HTP], and nicotine pouch products [NPP]), and how the appeal is modulated by relative price and user type. Exclusive cigarette smokers and dual cigarette/NVP users, stratified by age, will complete multiple scenarios in the ETM.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Exclusive cigarette smokers | Experimental | Exclusive cigarette smokers will be recruited and will be exposed to all of the conditions described in the intervention section. |
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| Dual cigarette/ nicotine vaping product users | Experimental | Dual cigarette and nicotine vaping product users will be recruited and will be exposed to all of the conditions described in the intervention section. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| All nicotine/ tobacco products at market price | Other | Nicotine/tobacco products available in the Experimental Tobacco Marketplace at market price. Note that all participants will complete all the specified conditions. |
| Measure | Description | Time Frame |
|---|---|---|
| Nicotine/Tobacco Products Substitution | Participants will complete purchasing trials in an Experimental Tobacco Marketplace (ETM) with cigarettes increasing in price. Other product prices in the ETM will depend on the experimental condition. The degree to which other nicotine/tobacco products substitute for conventional cigarettes as a function of novel product (e.g. nicotine vaping products, heated tobacco products, nicotine pouch products) prices will be assessed. To obtain estimates of substitution of price-constant products in the different ETM conditions, the investigators will use ordinary least squares regression to model the relationship of the price-manipulated product to predict total quantity purchased of the price-constant product. | 1 day |
| Cigarette Demand | Participants will complete purchasing trials in an Experimental Tobacco Marketplace (ETM) with cigarettes increasing in price. Other product prices in the ETM will depend on the experimental condition. The degree to which other nicotine/tobacco products substitute for conventional cigarettes as a function of novel product (e.g. nicotine vaping products, heated tobacco products, nicotine pouch products) prices will be assessed. To obtain dependent measures of demand, participants' purchasing of the price-manipulated commodity in the ETM task will be fit to a modified exponential equation to quantify the relationship between the price of each commodity and purchasing: Q=Q0*10k(exp(-αQ0C)-1) where Q is purchasing of the commodity, C is the price, Q0 is the derived initial purchasing without cost constraints (demand intensity), k is the span of the function in logarithmic units, and α is the demand elasticity. | 1 day |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Warren K Bickel, Ph.D. | Fralin Biomedical Research Institute at VTC | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fralin Biomedical Research Institute | Roanoke | Virginia | 24016 | United States |
The study team will share de-identified data upon request.
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Participants are assigned to exclusive smokers or dual cigarette/nicotine vaping product users groups based on the screening form.
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| ID | Title | Description |
|---|---|---|
| FG000 | Exclusive Cigarette Smokers | Exclusive smokers will be recruited and exposed to all conditions described in the intervention section. All nicotine/ tobacco products at market price: Nicotine/tobacco products available in the Experimental Tobacco Marketplace (ETM) at market price. Nicotine vaping products at 1/2 market price: Availability of nicotine vaping products in the ETM at 1/2 market price. Other nicotine/tobacco products at market price. Nicotine vaping products at 2x market price: Availability of nicotine vaping products in the ETM at 2x market price. Other nicotine/tobacco products at market price. Heated tobacco products at 1/2 market price.: Availability of heated tobacco products in the ETM at 1/2 market price. Other nicotine/tobacco products at market price. Heated tobacco products at 2x market price.: Availability of heated tobacco products in the ETM at 2x market price. Other nicotine/tobacco products at market price. Nicotine pouch products at 1/2 market price.: Availability of heated tobacco products in the ETM at 1/2 market price. Other nicotine/tobacco products at market price. Nicotine pouch products at 2x market price.: Availability of heated tobacco products in the ETM at 2x market price. Other nicotine/tobacco products at market price. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Dec 9, 2022 |
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Participants will complete seven Experimental Tobacco Marketplace conditions. Conventional cigarette price will be parametrically increased, and the purchasing of alternative products measured. Alternative products (i.e. nicotine vaping products, heated tobacco products and nicotine pouches) will be available at different prices in separate conditions (i.e., ½ market price, market price, and 2x market price).
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| Nicotine vaping products at 1/2 market price | Other | Availability of nicotine vaping products in the Experimental Tobacco Marketplace at 1/2 market price. Other nicotine/tobacco products at market price. Note that all participants will complete all the specified conditions. |
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| Nicotine vaping products at 2x market price | Other | Availability of nicotine vaping products in the Experimental Tobacco Marketplace at 2x market price. Other nicotine/tobacco products at market price. Note that all participants will complete all the specified conditions. |
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| Heated tobacco products at 1/2 market price. | Other | Availability of heated tobacco products in the Experimental Tobacco Marketplace at 1/2 market price. Other nicotine/tobacco products at market price. Note that all participants will complete all the specified conditions. |
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| Heated tobacco products at 2x market price. | Other | Availability of heated tobacco products in the Experimental Tobacco Marketplace at 2x market price. Other nicotine/tobacco products at market price. Note that all participants will complete all the specified conditions. |
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| Nicotine pouch products at 1/2 market price. | Other | Availability of heated tobacco products in the Experimental Tobacco Marketplace at 1/2 market price. Other nicotine/tobacco products at market price. Note that all participants will complete all the specified conditions. |
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| Nicotine pouch products at 2x market price. | Other | Availability of heated tobacco products in the Experimental Tobacco Marketplace at 2x market price. Other nicotine/tobacco products at market price. Note that all participants will complete all the specified conditions. |
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| FG001 | Dual Cigarette/ Nicotine Vaping Product Users | Dual cigarette and nicotine vaping product users will be recruited and exposed to all conditions described in the intervention section. All nicotine/ tobacco products at market price: Nicotine/tobacco products available in the Experimental Tobacco Marketplace (ETM) at market price. Note that all participants will complete all the specified conditions. Nicotine vaping products at 1/2 market price: Availability of nicotine vaping products in the ETM at 1/2 market price. Other nicotine/tobacco products at market price. Nicotine vaping products at 2x market price: Availability of nicotine vaping products in the ETM at 2x market price. Other nicotine/tobacco products at market price. Heated tobacco products at 1/2 market price.: Availability of heated tobacco products in the ETM at 1/2 market price. Other nicotine/tobacco products at market price. Heated tobacco products at 2x market price.: Availability of heated tobacco products in the ETM at 2x market price. Other nicotine/tobacco products at market price. Nicotine pouch products at 1/2 market price.: Availability of heated tobacco products in the ETM at 1/2 market price. Other nicotine/tobacco products at market price. Nicotine pouch products at 2x market price.: Availability of heated tobacco products in the ETM at 2x market price. Other nicotine/tobacco products at market price. |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Exclusive Cigarette Smokers | Exclusive smokers will be recruited and exposed to all conditions described in the intervention section. All nicotine/ tobacco products at market price: Nicotine/tobacco products available in the Experimental Tobacco Marketplace (ETM) at market price. Nicotine vaping products at 1/2 market price: Availability of nicotine vaping products in the ETM at 1/2 market price. Other nicotine/tobacco products at market price. Nicotine vaping products at 2x market price: Availability of nicotine vaping products in the ETM at 2x market price. Other nicotine/tobacco products at market price. Heated tobacco products at 1/2 market price.: Availability of heated tobacco products in the ETM at 1/2 market price. Other nicotine/tobacco products at market price. Heated tobacco products at 2x market price.: Availability of heated tobacco products in the ETM at 2x market price. Other nicotine/tobacco products at market price. Nicotine pouch products at 1/2 market price.: Availability of heated tobacco products in the ETM at 1/2 market price. Other nicotine/tobacco products at market price. Nicotine pouch products at 2x market price.: Availability of heated tobacco products in the ETM at 2x market price. Other nicotine/tobacco products at market price. |
| BG001 | Dual Cigarette/ Nicotine Vaping Product Users | Dual cigarette and nicotine vaping product users will be recruited and exposed to all conditions described in the intervention section. All nicotine/ tobacco products at market price: Nicotine/tobacco products available in the Experimental Tobacco Marketplace (ETM) at market price. Note that all participants will complete all the specified conditions. Nicotine vaping products at 1/2 market price: Availability of nicotine vaping products in the ETM at 1/2 market price. Other nicotine/tobacco products at market price. Nicotine vaping products at 2x market price: Availability of nicotine vaping products in the ETM at 2x market price. Other nicotine/tobacco products at market price. Heated tobacco products at 1/2 market price.: Availability of heated tobacco products in the ETM at 1/2 market price. Other nicotine/tobacco products at market price. Heated tobacco products at 2x market price.: Availability of heated tobacco products in the ETM at 2x market price. Other nicotine/tobacco products at market price. Nicotine pouch products at 1/2 market price.: Availability of heated tobacco products in the ETM at 1/2 market price. Other nicotine/tobacco products at market price. Nicotine pouch products at 2x market price.: Availability of heated tobacco products in the ETM at 2x market price. Other nicotine/tobacco products at market price. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
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| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Number of cigarettes smoked per day | Mean | Standard Deviation | cigarettes smoked per day |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Nicotine/Tobacco Products Substitution | Participants will complete purchasing trials in an Experimental Tobacco Marketplace (ETM) with cigarettes increasing in price. Other product prices in the ETM will depend on the experimental condition. The degree to which other nicotine/tobacco products substitute for conventional cigarettes as a function of novel product (e.g. nicotine vaping products, heated tobacco products, nicotine pouch products) prices will be assessed. To obtain estimates of substitution of price-constant products in the different ETM conditions, the investigators will use ordinary least squares regression to model the relationship of the price-manipulated product to predict total quantity purchased of the price-constant product. | Posted | Mean | Standard Deviation | mg of nicotine purchased | 1 day |
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| Primary | Cigarette Demand | Participants will complete purchasing trials in an Experimental Tobacco Marketplace (ETM) with cigarettes increasing in price. Other product prices in the ETM will depend on the experimental condition. The degree to which other nicotine/tobacco products substitute for conventional cigarettes as a function of novel product (e.g. nicotine vaping products, heated tobacco products, nicotine pouch products) prices will be assessed. To obtain dependent measures of demand, participants' purchasing of the price-manipulated commodity in the ETM task will be fit to a modified exponential equation to quantify the relationship between the price of each commodity and purchasing: Q=Q0*10k(exp(-αQ0C)-1) where Q is purchasing of the commodity, C is the price, Q0 is the derived initial purchasing without cost constraints (demand intensity), k is the span of the function in logarithmic units, and α is the demand elasticity. | Posted | Mean | Standard Deviation | mg of nicotine purchased | 1 day |
|
3 weeks
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Exclusive Cigarette Smokers | Exclusive smokers will be recruited and exposed to all conditions described in the intervention section. All nicotine/ tobacco products at market price: Nicotine/tobacco products available in the Experimental Tobacco Marketplace (ETM) at market price. Nicotine vaping products at 1/2 market price: Availability of nicotine vaping products in the ETM at 1/2 market price. Other nicotine/tobacco products at market price. Nicotine vaping products at 2x market price: Availability of nicotine vaping products in the ETM at 2x market price. Other nicotine/tobacco products at market price. Heated tobacco products at 1/2 market price.: Availability of heated tobacco products in the ETM at 1/2 market price. Other nicotine/tobacco products at market price. Heated tobacco products at 2x market price.: Availability of heated tobacco products in the ETM at 2x market price. Other nicotine/tobacco products at market price. Nicotine pouch products at 1/2 market price.: Availability of heated tobacco products in the ETM at 1/2 market price. Other nicotine/tobacco products at market price. Nicotine pouch products at 2x market price.: Availability of heated tobacco products in the ETM at 2x market price. Other nicotine/tobacco products at market price. | 0 | 26 | 0 | 26 | 0 | 26 |
| EG001 | Dual Cigarette/ Nicotine Vaping Product Users | Dual cigarette and nicotine vaping product users will be recruited and exposed to all conditions described in the intervention section. All nicotine/ tobacco products at market price: Nicotine/tobacco products available in the Experimental Tobacco Marketplace (ETM) at market price. Note that all participants will complete all the specified conditions. Nicotine vaping products at 1/2 market price: Availability of nicotine vaping products in the ETM at 1/2 market price. Other nicotine/tobacco products at market price. Nicotine vaping products at 2x market price: Availability of nicotine vaping products in the ETM at 2x market price. Other nicotine/tobacco products at market price. Heated tobacco products at 1/2 market price.: Availability of heated tobacco products in the ETM at 1/2 market price. Other nicotine/tobacco products at market price. Heated tobacco products at 2x market price.: Availability of heated tobacco products in the ETM at 2x market price. Other nicotine/tobacco products at market price. Nicotine pouch products at 1/2 market price.: Availability of heated tobacco products in the ETM at 1/2 market price. Other nicotine/tobacco products at market price. Nicotine pouch products at 2x market price.: Availability of heated tobacco products in the ETM at 2x market price. Other nicotine/tobacco products at market price. | 0 | 26 | 0 | 26 | 0 | 26 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Roberta Freitas-Lemos | Fralin Biomedical Research Institute at VTC | (540)526-2106 | rflemos@vtc.vt.edu |
| Aug 28, 2024 |
| Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| D000073865 | Cigarette Smoking |
| D000072137 | Vaping |
| ID | Term |
|---|---|
| D000073869 | Tobacco Smoking |
| D012907 | Smoking |
| D001519 | Behavior |
| D064424 | Tobacco Use |
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| Male |
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| Not Hispanic or Latino |
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| Unknown or Not Reported |
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| Asian |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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| HTP 2 |
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| NPP 1/2 |
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| NPP 2 |
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| NVP 1/2 |
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| NVP 2 |
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| OG001 | Dual Cigarette/ Nicotine Vaping Product Users | Dual cigarette and nicotine vaping product users will be recruited and exposed to all conditions described in the intervention section. All nicotine/ tobacco products at market price: Nicotine/tobacco products available in the Experimental Tobacco Marketplace (ETM) at market price. Note that all participants will complete all the specified conditions. Nicotine vaping products at 1/2 market price: Availability of nicotine vaping products in the ETM at 1/2 market price. Other nicotine/tobacco products at market price. Nicotine vaping products at 2x market price: Availability of nicotine vaping products in the ETM at 2x market price. Other nicotine/tobacco products at market price. Heated tobacco products at 1/2 market price.: Availability of heated tobacco products in the ETM at 1/2 market price. Other nicotine/tobacco products at market price. Heated tobacco products at 2x market price.: Availability of heated tobacco products in the ETM at 2x market price. Other nicotine/tobacco products at market price. Nicotine pouch products at 1/2 market price.: Availability of heated tobacco products in the ETM at 1/2 market price. Other nicotine/tobacco products at market price. Nicotine pouch products at 2x market price.: Availability of heated tobacco products in the ETM at 2x market price. Other nicotine/tobacco products at market price. |
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