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| ID | Type | Description | Link |
|---|---|---|---|
| R01CA260460 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| Brown University | OTHER |
| National Institutes of Health (NIH) | NIH |
| Food and Drug Administration (FDA) | FED |
| National Cancer Institute (NCI) |
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The purpose of this study is to determine whether different cigarillo warning formats (pictorial, FDA-proposed text-only, current Surgeon General text-only) reduces demand for cigarillos. A previous study has identified that pictorial cigarillo warnings are perceived as more effective, but more information is needed on their impact. This study will address this issue by randomizing participants to see different cigarillo warning formats on cigarillo products within an online experimental tobacco marketplace. Participants will be cigarillo users who are ages 21-35.
Warning labels on tobacco products convey the health risks and discourage use. Warnings are even more effective when they contain images that depict the health consequences. However, little is known about the impact of cigarillo warnings, including pictorial warnings, on consumer behavior. The Experimental Tobacco Marketplace (ETM) task examines the effects of regulations on tobacco purchasing in the context of a complex tobacco marketplace. This project aims to address the gap in the knowledge about cigarillo risk communication by providing information on best practices for cigarillo warnings. Identifying effective cigarillo warnings is important to inform policy and guide research on effectively communicating risk to ultimately decrease use and tobacco-related morbidity and mortality.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cigarillo warnings-Surgeon General Text-Only | Experimental | Participants will complete 6 mock shopping trips in the Experimental Tobacco Marketplace, and be asked to spend their weekly tobacco budget. Cigarillos in the Marketplace will have one of three cigarillo warnings in the Surgeon General Text-Only format. |
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| Cigarillo warnings-FDA proposed text-only | Experimental | Participants will complete 6 mock shopping trips in the Experimental Tobacco Marketplace, and be asked to spend their weekly tobacco budget. Cigarillos in the Marketplace will have one of three cigarillo warnings in the FDA Proposed Text-Only format. |
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| Cigarillo warnings-Pictorial | Experimental | Participants will complete 6 mock shopping trips in the Experimental Tobacco Marketplace, and be asked to spend their weekly tobacco budget. Cigarillos in the Marketplace will have one of three cigarillo warnings in the Pictorial format. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cigarillo warnings-Surgeon General Text-Only | Behavioral | Participants will complete 6 mock shopping trips in the Experimental Tobacco Marketplace, and be asked to spend their weekly tobacco budget. Cigarillos in the Marketplace will have one of three cigarillo warnings in the Surgeon General Text-Only format. |
| Measure | Description | Time Frame |
|---|---|---|
| Average Total Number of Cigarillos Purchased | Participants in each arm will participate in six mock shopping trips with a specified budget. They will purchase (mock) single cigarillos. The primary outcome is the average number of cigarillos purchased during each of the six mock shopping trips. | Within the 20-minute survey |
| Measure | Description | Time Frame |
|---|---|---|
| Average Total Amount of mg Combusted Tobacco Purchased | Participants will participate in six mock shopping trips with a specified budget. They will have the option to purchase (mock) tobacco products in addition to cigarillos: cigarettes, menthol cigarettes, e-cigarettes/vaping devices, oral nicotine. This outcome will be the sum mg of the number of combusted non-cigarillo tobacco products purchased during each of the six mock shopping trips |
| Measure | Description | Time Frame |
|---|---|---|
| Negative Affect | Three survey items to measure emotional reactions (anxious, scared, disgusted) to the cigarillo warning the participant saw. Response options are on a 1 to 5 scale. Overall scale scores are determined by summing scores of the 4 items and dividing by 4 (range 1-5), with higher scores representing a higher amount of the construct. | Within the 20-minute survey |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jennifer C Ross, PhD | BU School of Public Health | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Wake Forest University Health Sciences | Winston-Salem | North Carolina | 27157 | United States |
Deidentified individual data may be provided to qualified investigators starting 9 months and ending 36 months after publication. Investigators proposing to use the data must receive a data use agree with Wake Forest University Health Sciences and seek approval from an Institutional Review Board (IRB), or similar body identified for this purpose.
9-36 months following publication
Qualified researchers engaged in independent scientific research with IRB approval and a data use agreement with Wake Forest University Health Sciences.
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| ID | Title | Description |
|---|---|---|
| FG000 | Cigarillo Warnings-Surgeon General Text-Only | Participants will complete 6 mock shopping trips in the Experimental Tobacco Marketplace, and be asked to spend their weekly tobacco budget. Cigarillos in the Marketplace will have one of three cigarillo warnings in the Surgeon General Text-Only format. Cigarillo warnings-Surgeon General Text-Only: Participants will complete 6 mock shopping trips in the Experimental Tobacco Marketplace, and be asked to spend their weekly tobacco budget. Cigarillos in the Marketplace will have one of three cigarillo warnings in the Surgeon General Text-Only format. |
| FG001 | Cigarillo Warnings-FDA Proposed Text-only | Participants will complete 6 mock shopping trips in the Experimental Tobacco Marketplace, and be asked to spend their weekly tobacco budget. Cigarillos in the Marketplace will have one of three cigarillo warnings in the FDA Proposed Text-Only format. Cigarillo warnings-FDA proposed text-only: Participants will complete 6 mock shopping trips in the Experimental Tobacco Marketplace, and be asked to spend their weekly tobacco budget. Cigarillos in the Marketplace will have one of three cigarillo warnings in the FDA Proposed Text-Only format. |
| FG002 | Cigarillo Warnings-Pictorial | Participants will complete 6 mock shopping trips in the Experimental Tobacco Marketplace, and be asked to spend their weekly tobacco budget. Cigarillos in the Marketplace will have one of three cigarillo warnings in the Pictorial format. Cigarillo warnings-Pictorial: Participants will complete 6 mock shopping trips in the Experimental Tobacco Marketplace, and be asked to spend their weekly tobacco budget. Cigarillos in the Marketplace will have one of three cigarillo warnings in the Pictorial format. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Cigarillo Warnings-Surgeon General Text-Only | Participants will complete 6 mock shopping trips in the Experimental Tobacco Marketplace, and be asked to spend their weekly tobacco budget. Cigarillos in the Marketplace will have one of three cigarillo warnings in the Surgeon General Text-Only format. Cigarillo warnings-Surgeon General Text-Only: Participants will complete 6 mock shopping trips in the Experimental Tobacco Marketplace, and be asked to spend their weekly tobacco budget. Cigarillos in the Marketplace will have one of three cigarillo warnings in the Surgeon General Text-Only format. |
| Units | Counts |
|---|---|
| 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 |
| 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 | Average Total Number of Cigarillos Purchased | Participants in each arm will participate in six mock shopping trips with a specified budget. They will purchase (mock) single cigarillos. The primary outcome is the average number of cigarillos purchased during each of the six mock shopping trips. | Posted | Mean | Standard Deviation | cigarillos | Within the 20-minute survey |
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20 minutes
Study is minimal risk
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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 | Cigarillo Warnings-Surgeon General Text-Only | Participants will complete 6 mock shopping trips in the Experimental Tobacco Marketplace, and be asked to spend their weekly tobacco budget. Cigarillos in the Marketplace will have one of three cigarillo warnings in the Surgeon General Text-Only format. Cigarillo warnings-Surgeon General Text-Only: Participants will complete 6 mock shopping trips in the Experimental Tobacco Marketplace, and be asked to spend their weekly tobacco budget. Cigarillos in the Marketplace will have one of three cigarillo warnings in the Surgeon General Text-Only format. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Jennifer Ross, PhD | BU School of Public Health | 617 358 1905 | jjross@bu.edu |
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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 | Apr 12, 2022 | May 16, 2023 | Prot_SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Apr 7, 2022 | Aug 24, 2022 | ICF_000.pdf |
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| ID | Term |
|---|---|
| D000073863 | Cigar Smoking |
| ID | Term |
|---|---|
| D000073869 | Tobacco Smoking |
| D012907 | Smoking |
| D001519 | Behavior |
| D064424 | Tobacco Use |
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| NIH |
| Wake Forest University Health Sciences | OTHER |
The study will conduct a three-group, between-subjects experiment to compare varying cigarillo warning formats: Surgeon General text-only, FDA-proposed text-only, and study developed pictorial cigarillo warning labels.
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Participants will be randomly assigned to one of 3 conditions. In each of these conditions participants will see one of the following warning label formats on the cigarillos when they are shopping for tobacco products: a pictorial warning, a text-based warning, or a surgeon general warning. Participants don't know which condition they're assigned to.
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| Cigarillo warnings-FDA proposed text-only | Behavioral | Participants will complete 6 mock shopping trips in the Experimental Tobacco Marketplace, and be asked to spend their weekly tobacco budget. Cigarillos in the Marketplace will have one of three cigarillo warnings in the FDA Proposed Text-Only format. |
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| Cigarillo warnings-Pictorial | Behavioral | Participants will complete 6 mock shopping trips in the Experimental Tobacco Marketplace, and be asked to spend their weekly tobacco budget. Cigarillos in the Marketplace will have one of three cigarillo warnings in the Pictorial format. |
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| Within the 20-minute survey |
| Average Total Amount of mg Non-combusted Tobacco Purchased | Participants will participate in six mock shopping trips with a specified budget. They will have the option to purchase (mock) tobacco products in addition to cigarillos: cigarettes, menthol cigarettes, e-cigarettes/vaping devices, oral nicotine. This outcome will be the sum mg of the number of non-combusted tobacco products purchased during each of the six mock shopping trips. | Within the 20-minute survey |
| Intensity Index for Cigarillos | Number of cigarillos purchased at lowest price, averaged across the six shopping trips | Within the 20 minute survey. |
| Cost Related Indices for Cigarillos | Omax is the maximum amount spent on cigarillos across all shopping trips. Breakpoint is the price where no cigarillos were purchased. Pmax is the price where Omax occurs. | Within the 20-minute survey |
| Rate of Change for Cigarillo Demand | The rate of change for cigarillo demand is called Alpha, which is the rate constant of fitted Exponentiated Demand Equation. It is calculated with the Exponentiated Demand Equation, Q=Q0*10^k(e-αQ0C -1), where Q is the mg of nicotine purchased at a given price, Q0 is peak demand consumption or intensity (typically occurring at the lowest price), k is a constant across all compared conditions, and alpha (α) is the rate of change in demand or elasticity. | Within the 20-minute survey |
| Cognitive Elaboration | The 1 item measure assesses the extent to which a participant reports the warning making them think about the risks of cigarillo smoking. Response options are on a 1 to 5 scale, with higher scores representing a higher amount of the construct. | Within the 20-minute survey |
| Intentions to Quit Using Cigarillos | Three survey items to measure participant's interest in quitting cigarillo smoking in the next month, likelihood of quitting smoking cigarillos in the month week, and plans to quit smoking cigarillos in the next month. Response options are on a 1 to 5 scale. Overall scale scores are determined by summing the scores of the 3 items and dividing by 3 (range 1-5), with higher scores representing a higher amount of the construct/intentions to quit | Within the 20-minute survey |
| Warning Recall | one survey item asking participants if they noticed any health warnings on the cigarillo packages during their shopping tasks, with response options of Yes, No, and I'm not sure. Recall will be determine if participants select Yes. | Within the 20-minute survey |
| Warning Recognition | One survey item asking participants to identify which warning they saw during their mock shopping trips. Participants will be shown their warning, a warning that wasn't in their ETM, and "I don't know" response options. Selecting the correct warning indicates warning recognition. | Within the 20-minute survey |
| Mean Perceived Message Effectiveness | The 3-item UNC mean perceived message effectiveness scale assesses a participant's judgement of a warning's impact on their cigarillo beliefs and behavior. Response options are on a 1 to 5 scale. Overall scores are determined by summing the scores of the 3 items and dividing by 3 (range 1-5), with higher scores representing a higher amount of the construct | Within the 20-minute survey |
| Self-Reported Learning | One survey item asking participants to what extent did they learn something new from the warning. Response options are on a 1 to 5 scale, with the higher number indicating more self-reported learning. | Within the 20-minute survey |
| Average Total Amount of Non-tobacco Products Purchased | Participants will participate in six mock shopping trips with a specified budget. They will have the option to purchase (mock) tobacco products in addition to cigarillos: cigarettes, menthol cigarettes, e-cigarettes/vaping devices, oral nicotine, and two non-tobacco options: snack food and non-alcoholic beverage. This outcome will be the sum mg of the number of non- tobacco products purchased during each of the six mock shopping trips. | Within the 20-minute survey |
| BG001 | Cigarillo Warnings-FDA Proposed Text-only | Participants will complete 6 mock shopping trips in the Experimental Tobacco Marketplace, and be asked to spend their weekly tobacco budget. Cigarillos in the Marketplace will have one of three cigarillo warnings in the FDA Proposed Text-Only format. Cigarillo warnings-FDA proposed text-only: Participants will complete 6 mock shopping trips in the Experimental Tobacco Marketplace, and be asked to spend their weekly tobacco budget. Cigarillos in the Marketplace will have one of three cigarillo warnings in the FDA Proposed Text-Only format. |
| BG002 | Cigarillo Warnings-Pictorial | Participants will complete 6 mock shopping trips in the Experimental Tobacco Marketplace, and be asked to spend their weekly tobacco budget. Cigarillos in the Marketplace will have one of three cigarillo warnings in the Pictorial format. Cigarillo warnings-Pictorial: Participants will complete 6 mock shopping trips in the Experimental Tobacco Marketplace, and be asked to spend their weekly tobacco budget. Cigarillos in the Marketplace will have one of three cigarillo warnings in the Pictorial format. |
| BG003 | Total | Total of all reporting groups |
| Years |
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| Sex/Gender, Customized | Gender identity | 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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| Region of Enrollment | Number | participants |
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| OG001 | Cigarillo Warnings-FDA Proposed Text-only | Participants will complete 6 mock shopping trips in the Experimental Tobacco Marketplace, and be asked to spend their weekly tobacco budget. Cigarillos in the Marketplace will have one of three cigarillo warnings in the FDA Proposed Text-Only format. Cigarillo warnings-FDA proposed text-only: Participants will complete 6 mock shopping trips in the Experimental Tobacco Marketplace, and be asked to spend their weekly tobacco budget. Cigarillos in the Marketplace will have one of three cigarillo warnings in the FDA Proposed Text-Only format. |
| OG002 | Cigarillo Warnings-Pictorial | Participants will complete 6 mock shopping trips in the Experimental Tobacco Marketplace, and be asked to spend their weekly tobacco budget. Cigarillos in the Marketplace will have one of three cigarillo warnings in the Pictorial format. Cigarillo warnings-Pictorial: Participants will complete 6 mock shopping trips in the Experimental Tobacco Marketplace, and be asked to spend their weekly tobacco budget. Cigarillos in the Marketplace will have one of three cigarillo warnings in the Pictorial format. |
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| Secondary | Average Total Amount of mg Combusted Tobacco Purchased | Participants will participate in six mock shopping trips with a specified budget. They will have the option to purchase (mock) tobacco products in addition to cigarillos: cigarettes, menthol cigarettes, e-cigarettes/vaping devices, oral nicotine. This outcome will be the sum mg of the number of combusted non-cigarillo tobacco products purchased during each of the six mock shopping trips | Posted | Mean | Standard Error | mg of combusted tobacco purchased | Within the 20-minute survey |
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| Secondary | Average Total Amount of mg Non-combusted Tobacco Purchased | Participants will participate in six mock shopping trips with a specified budget. They will have the option to purchase (mock) tobacco products in addition to cigarillos: cigarettes, menthol cigarettes, e-cigarettes/vaping devices, oral nicotine. This outcome will be the sum mg of the number of non-combusted tobacco products purchased during each of the six mock shopping trips. | Posted | Mean | Standard Error | mg of non-combusted tobacco purchased | Within the 20-minute survey |
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| Secondary | Intensity Index for Cigarillos | Number of cigarillos purchased at lowest price, averaged across the six shopping trips | For this index, participants were removed whose baseline balance was insufficient to purchase any products and people who did not purchase anything. Another 50 cases were removed for violating modified bounce criterion. | Posted | Mean | Standard Deviation | number of cigarillos | Within the 20 minute survey. |
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| Other Pre-specified | Negative Affect | Three survey items to measure emotional reactions (anxious, scared, disgusted) to the cigarillo warning the participant saw. Response options are on a 1 to 5 scale. Overall scale scores are determined by summing scores of the 4 items and dividing by 4 (range 1-5), with higher scores representing a higher amount of the construct. | Not Posted | Within the 20-minute survey | Participants |
| Other Pre-specified | Cognitive Elaboration | The 1 item measure assesses the extent to which a participant reports the warning making them think about the risks of cigarillo smoking. Response options are on a 1 to 5 scale, with higher scores representing a higher amount of the construct. | Not Posted | Within the 20-minute survey | Participants |
| Other Pre-specified | Intentions to Quit Using Cigarillos | Three survey items to measure participant's interest in quitting cigarillo smoking in the next month, likelihood of quitting smoking cigarillos in the month week, and plans to quit smoking cigarillos in the next month. Response options are on a 1 to 5 scale. Overall scale scores are determined by summing the scores of the 3 items and dividing by 3 (range 1-5), with higher scores representing a higher amount of the construct/intentions to quit | Not Posted | Within the 20-minute survey | Participants |
| Other Pre-specified | Warning Recall | one survey item asking participants if they noticed any health warnings on the cigarillo packages during their shopping tasks, with response options of Yes, No, and I'm not sure. Recall will be determine if participants select Yes. | Not Posted | Within the 20-minute survey | Participants |
| Other Pre-specified | Warning Recognition | One survey item asking participants to identify which warning they saw during their mock shopping trips. Participants will be shown their warning, a warning that wasn't in their ETM, and "I don't know" response options. Selecting the correct warning indicates warning recognition. | Not Posted | Within the 20-minute survey | Participants |
| Other Pre-specified | Mean Perceived Message Effectiveness | The 3-item UNC mean perceived message effectiveness scale assesses a participant's judgement of a warning's impact on their cigarillo beliefs and behavior. Response options are on a 1 to 5 scale. Overall scores are determined by summing the scores of the 3 items and dividing by 3 (range 1-5), with higher scores representing a higher amount of the construct | Not Posted | Within the 20-minute survey | Participants |
| Other Pre-specified | Self-Reported Learning | One survey item asking participants to what extent did they learn something new from the warning. Response options are on a 1 to 5 scale, with the higher number indicating more self-reported learning. | Not Posted | Within the 20-minute survey | Participants |
| Other Pre-specified | Average Total Amount of Non-tobacco Products Purchased | Participants will participate in six mock shopping trips with a specified budget. They will have the option to purchase (mock) tobacco products in addition to cigarillos: cigarettes, menthol cigarettes, e-cigarettes/vaping devices, oral nicotine, and two non-tobacco options: snack food and non-alcoholic beverage. This outcome will be the sum mg of the number of non- tobacco products purchased during each of the six mock shopping trips. | Not Posted | Within the 20-minute survey | Participants |
| Secondary | Cost Related Indices for Cigarillos | Omax is the maximum amount spent on cigarillos across all shopping trips. Breakpoint is the price where no cigarillos were purchased. Pmax is the price where Omax occurs. | For this index, participants were removed whose baseline balance was insufficient to purchase any products and people who did not purchase anything. Another 50 cases were removed for violating modified bounce criterion. | Posted | Mean | Standard Deviation | dollars | Within the 20-minute survey |
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| Secondary | Rate of Change for Cigarillo Demand | The rate of change for cigarillo demand is called Alpha, which is the rate constant of fitted Exponentiated Demand Equation. It is calculated with the Exponentiated Demand Equation, Q=Q0*10^k(e-αQ0C -1), where Q is the mg of nicotine purchased at a given price, Q0 is peak demand consumption or intensity (typically occurring at the lowest price), k is a constant across all compared conditions, and alpha (α) is the rate of change in demand or elasticity. | For Alpha, cases were removed for negative alphas values indicating poor/implausible fits. Cases were were also removed for negative curvature to the data (i.e., a mostly flat line), which does not allow alpha to be generated. Additional cases for each group were removed if alpha could not be calculated leading to the smaller numbers of participants analyzed in each group. | Posted | Mean | Standard Deviation | cigarillos/dollar | Within the 20-minute survey |
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| 0 |
| 526 |
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| 526 |
| 0 |
| 526 |
| EG001 | Cigarillo Warnings-FDA Proposed Text-only | Participants will complete 6 mock shopping trips in the Experimental Tobacco Marketplace, and be asked to spend their weekly tobacco budget. Cigarillos in the Marketplace will have one of three cigarillo warnings in the FDA Proposed Text-Only format. Cigarillo warnings-FDA proposed text-only: Participants will complete 6 mock shopping trips in the Experimental Tobacco Marketplace, and be asked to spend their weekly tobacco budget. Cigarillos in the Marketplace will have one of three cigarillo warnings in the FDA Proposed Text-Only format. | 0 | 526 | 0 | 526 | 0 | 526 |
| EG002 | Cigarillo Warnings-Pictorial | Participants will complete 6 mock shopping trips in the Experimental Tobacco Marketplace, and be asked to spend their weekly tobacco budget. Cigarillos in the Marketplace will have one of three cigarillo warnings in the Pictorial format. Cigarillo warnings-Pictorial: Participants will complete 6 mock shopping trips in the Experimental Tobacco Marketplace, and be asked to spend their weekly tobacco budget. Cigarillos in the Marketplace will have one of three cigarillo warnings in the Pictorial format. | 0 | 526 | 0 | 526 | 0 | 526 |
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| Pmax-price where Omax occurs |
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