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| ID | Type | Description | Link |
|---|---|---|---|
| P01CA217806 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| University of Minnesota | OTHER |
| National Cancer Institute (NCI) | NIH |
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This is a one-session study that participants complete remotely including consent, Experimental Tobacco Marketplace purchases, and assessments to examine the effects of cigarette and e-cigarette flavors on cigarette demand and substitution in the Experimental Tobacco Marketplace.
This study uses a mixed design (within-subject repeated measures and between-group). Participants will be assigned to two different groups according to their preferred cigarette flavor (tobacco/menthol). Every participant will complete behavioral tasks and make hypothetical purchases of tobacco products in an online store under four different scenarios: a) e-cigarette flavor restricted and cigarette flavor restricted, b) e-cigarette flavor unrestricted and cigarette flavor restricted, c) e-cigarette flavor restricted and cigarette flavor unrestricted, d) e-cigarette flavor unrestricted and cigarette flavor unrestricted.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Menthol cigarette smokers | Experimental | Adults (21 y.o. and older) who smoke ate least 10 menthol cigarettes per day will be recruited. |
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| Non-menthol cigarette smokers | Experimental | Adults (21 y.o. and older) who smoke ate least 10 non-menthol cigarettes per day will be recruited. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cigarette flavor restricted and e-cigarette flavor restricted | Behavioral |
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| Measure | Description | Time Frame |
|---|---|---|
| Spent the Budget on E-cigarettes for Each Condition | Participants will complete purchasing trials in an Experimental Tobacco Marketplace (ETM) with cigarettes increasing in price. Product availability in the ETM depended on the experimental condition. The average percentage of budget spent on e-cigarettes as a function of the restriction of cigarettes and/or e-cigarettes will be assessed. | 1 day |
| Spent Budget on Cigarettes for Each Condition | Participants will complete purchasing trials in an Experimental Tobacco Marketplace (ETM) with cigarettes increasing in price. Product availability in the ETM depended on the experimental condition. The average percentage of the budget spent on cigarettes as a function of the restriction of cigarettes and/or e-cigarettes will be assessed. | 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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| ID | Title | Description |
|---|---|---|
| FG000 | Menthol Cigarette Smokers | Adults (21 y.o. and older) who smoke ate least 10 menthol cigarettes per day will be recruited. Cigarette flavor restricted and e-cigarette flavor restricted: 1) Tobacco cigarettes will be available in the Experimental Tobacco Marketplace 2) Tobacco-flavored e-cigarettes will be available in the Experimental Tobacco Marketplace Cigarette flavor restricted and e-cigarette flavor unrestricted: 1) Tobacco cigarettes will be available in the Experimental Tobacco Marketplace 2) Tobacco-flavored and a range of flavored e-cigarettes will be available in the Experimental Tobacco Marketplace Cigarette flavor unrestricted and e-cigarette flavor restricted: 1) Tobacco and menthol cigarettes will be available in the Experimental Tobacco Marketplace 2) Tobacco-flavored e-cigarettes will be available in the Experimental Tobacco Marketplace Cigarette flavor unrestricted and e-cigarette flavor unrestricted: 1) Tobacco and menthol cigarettes will be available in the Experimental Tobacco Marketplace 2) Tobacco-flavored and a range of flavored e-cigarettes will be available in the Experimental Tobacco Marketplace |
| 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_ICF | Yes | Yes | Yes | Study Protocol, Statistical Analysis Plan, and Informed Consent Form | Mar 5, 2019 |
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Participants will complete different purchasing scenarios in the Experimental Tobacco Marketplace in which different cigarette and e-cigarette flavors are available. In all scenarios, a range of other tobacco products will also be available.
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The study design included automated randomization of the conditions per person at the time of completion, via Qualtrics Software.
| Cigarette flavor restricted and e-cigarette flavor unrestricted | Behavioral |
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| Cigarette flavor unrestricted and e-cigarette flavor restricted | Behavioral |
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| Cigarette flavor unrestricted and e-cigarette flavor unrestricted | Behavioral |
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| FG001 | Non-menthol Cigarette Smokers | Adults (21 y.o. and older) who smoke ate least 10 non-menthol cigarettes per day will be recruited. Cigarette flavor restricted and e-cigarette flavor restricted: 1) Tobacco cigarettes will be available in the Experimental Tobacco Marketplace 2) Tobacco-flavored e-cigarettes will be available in the Experimental Tobacco Marketplace Cigarette flavor restricted and e-cigarette flavor unrestricted: 1) Tobacco cigarettes will be available in the Experimental Tobacco Marketplace 2) Tobacco-flavored and a range of flavored e-cigarettes will be available in the Experimental Tobacco Marketplace Cigarette flavor unrestricted and e-cigarette flavor restricted: 1) Tobacco and menthol cigarettes will be available in the Experimental Tobacco Marketplace 2) Tobacco-flavored e-cigarettes will be available in the Experimental Tobacco Marketplace Cigarette flavor unrestricted and e-cigarette flavor unrestricted: 1) Tobacco and menthol cigarettes will be available in the Experimental Tobacco Marketplace 2) Tobacco-flavored and a range of flavored e-cigarettes will be available in the Experimental Tobacco Marketplace |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Menthol Cigarette Smokers | Adults (21 y.o. and older) who smoke ate least 10 menthol cigarettes per day will be recruited. Cigarette flavor restricted and e-cigarette flavor restricted: 1) Tobacco cigarettes will be available in the Experimental Tobacco Marketplace 2) Tobacco-flavored e-cigarettes will be available in the Experimental Tobacco Marketplace Cigarette flavor restricted and e-cigarette flavor unrestricted: 1) Tobacco cigarettes will be available in the Experimental Tobacco Marketplace 2) Tobacco-flavored and a range of flavored e-cigarettes will be available in the Experimental Tobacco Marketplace Cigarette flavor unrestricted and e-cigarette flavor restricted: 1) Tobacco and menthol cigarettes will be available in the Experimental Tobacco Marketplace 2) Tobacco-flavored e-cigarettes will be available in the Experimental Tobacco Marketplace Cigarette flavor unrestricted and e-cigarette flavor unrestricted: 1) Tobacco and menthol cigarettes will be available in the Experimental Tobacco Marketplace 2) Tobacco-flavored and a range of flavored e-cigarettes will be available in the Experimental Tobacco Marketplace |
| BG001 | Non-menthol Cigarette Smokers | Adults (21 y.o. and older) who smoke ate least 10 non-menthol cigarettes per day will be recruited. Cigarette flavor restricted and e-cigarette flavor restricted: 1) Tobacco cigarettes will be available in the Experimental Tobacco Marketplace 2) Tobacco-flavored e-cigarettes will be available in the Experimental Tobacco Marketplace Cigarette flavor restricted and e-cigarette flavor unrestricted: 1) Tobacco cigarettes will be available in the Experimental Tobacco Marketplace 2) Tobacco-flavored and a range of flavored e-cigarettes will be available in the Experimental Tobacco Marketplace Cigarette flavor unrestricted and e-cigarette flavor restricted: 1) Tobacco and menthol cigarettes will be available in the Experimental Tobacco Marketplace 2) Tobacco-flavored e-cigarettes will be available in the Experimental Tobacco Marketplace Cigarette flavor unrestricted and e-cigarette flavor unrestricted: 1) Tobacco and menthol cigarettes will be available in the Experimental Tobacco Marketplace 2) Tobacco-flavored and a range of flavored e-cigarettes will be available in the Experimental Tobacco Marketplace |
| 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 | ||||||||||
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| Age, Continuous | Mean | Standard Deviation | years |
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| Sex/Gender, Customized | 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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| Cigarettes per day | Mean | Standard Deviation | cigarettes 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 | Spent the Budget on E-cigarettes for Each Condition | Participants will complete purchasing trials in an Experimental Tobacco Marketplace (ETM) with cigarettes increasing in price. Product availability in the ETM depended on the experimental condition. The average percentage of budget spent on e-cigarettes as a function of the restriction of cigarettes and/or e-cigarettes will be assessed. | Posted | Mean | Standard Error | percentage of spent budget | 1 day |
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| Primary | Spent Budget on Cigarettes for Each Condition | Participants will complete purchasing trials in an Experimental Tobacco Marketplace (ETM) with cigarettes increasing in price. Product availability in the ETM depended on the experimental condition. The average percentage of the budget spent on cigarettes as a function of the restriction of cigarettes and/or e-cigarettes will be assessed. | Posted | Mean | Standard Error | percentage of spent budget | 1 day |
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approximately 19 days
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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 | Menthol Cigarette Smokers | Adults (21 y.o. and older) who smoke ate least 10 menthol cigarettes per day will be recruited. Cigarette flavor restricted and e-cigarette flavor restricted: 1) Tobacco cigarettes will be available in the Experimental Tobacco Marketplace 2) Tobacco-flavored e-cigarettes will be available in the Experimental Tobacco Marketplace Cigarette flavor restricted and e-cigarette flavor unrestricted: 1) Tobacco cigarettes will be available in the Experimental Tobacco Marketplace 2) Tobacco-flavored and a range of flavored e-cigarettes will be available in the Experimental Tobacco Marketplace Cigarette flavor unrestricted and e-cigarette flavor restricted: 1) Tobacco and menthol cigarettes will be available in the Experimental Tobacco Marketplace 2) Tobacco-flavored e-cigarettes will be available in the Experimental Tobacco Marketplace Cigarette flavor unrestricted and e-cigarette flavor unrestricted: 1) Tobacco and menthol cigarettes will be available in the Experimental Tobacco Marketplace 2) Tobacco-flavored and a range of flavored e-cigarettes will be available in the Experimental Tobacco Marketplace | 0 | 140 | 0 | 140 | 0 | 140 |
| EG001 | Non-menthol Cigarette Smokers | Adults (21 y.o. and older) who smoke ate least 10 non-menthol cigarettes per day will be recruited. Cigarette flavor restricted and e-cigarette flavor restricted: 1) Tobacco cigarettes will be available in the Experimental Tobacco Marketplace 2) Tobacco-flavored e-cigarettes will be available in the Experimental Tobacco Marketplace Cigarette flavor restricted and e-cigarette flavor unrestricted: 1) Tobacco cigarettes will be available in the Experimental Tobacco Marketplace 2) Tobacco-flavored and a range of flavored e-cigarettes will be available in the Experimental Tobacco Marketplace Cigarette flavor unrestricted and e-cigarette flavor restricted: 1) Tobacco and menthol cigarettes will be available in the Experimental Tobacco Marketplace 2) Tobacco-flavored e-cigarettes will be available in the Experimental Tobacco Marketplace Cigarette flavor unrestricted and e-cigarette flavor unrestricted: 1) Tobacco and menthol cigarettes will be available in the Experimental Tobacco Marketplace 2) Tobacco-flavored and a range of flavored e-cigarettes will be available in the Experimental Tobacco Marketplace | 0 | 162 | 0 | 162 | 0 | 162 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Freitas-Lemos | Fralin Biomedical Research Institute at Virginia Tech Carilion | 540-526-2106 | rflemos@vtc.vt.edu |
| Sep 3, 2025 |
| Prot_SAP_ICF_000.pdf |
| ID | Term |
|---|---|
| D014029 | Tobacco Use Disorder |
| D000072137 | Vaping |
| ID | Term |
|---|---|
| D019966 | Substance-Related Disorders |
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
| D012907 | Smoking |
| D001519 | Behavior |
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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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| E-cigarette restriction |
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| No Restriction on Cigarettes or E-cigarettes |
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| Non-menthol Cigarette Smokers |
Adults (21 y.o. and older) who smoke ate least 10 non-menthol cigarettes per day will be recruited. Cigarette flavor restricted and e-cigarette flavor restricted: 1) Tobacco cigarettes will be available in the Experimental Tobacco Marketplace 2) Tobacco-flavored e-cigarettes will be available in the Experimental Tobacco Marketplace Cigarette flavor restricted and e-cigarette flavor unrestricted: 1) Tobacco cigarettes will be available in the Experimental Tobacco Marketplace 2) Tobacco-flavored and a range of flavored e-cigarettes will be available in the Experimental Tobacco Marketplace Cigarette flavor unrestricted and e-cigarette flavor restricted: 1) Tobacco and menthol cigarettes will be available in the Experimental Tobacco Marketplace 2) Tobacco-flavored e-cigarettes will be available in the Experimental Tobacco Marketplace Cigarette flavor unrestricted and e-cigarette flavor unrestricted: 1) Tobacco and menthol cigarettes will be available in the Experimental Tobacco Marketplace 2) Tobacco-flavored and a range of flavored e-cigarettes will be available in the Experimental Tobacco Marketplace |
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