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| ID | Type | Description | Link |
|---|---|---|---|
| R01DA049814 | 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 Family Smoking Prevention and Tobacco Control Act granted the FDA the authority to regulate and restrict tobacco advertising tactics that inaccurately convey reduced product risk, yet there is a dearth of up-to-date regulatory science to inform such regulations. Although the FDA has restricted use of descriptors such as "natural" and "additive-free," research shows that the tobacco industry quickly pivoted to increase use of alternative, unregulated tactics. Greenwashing is one increasingly common tobacco marketing strategy in which products are portrayed as eco-friendly and/or natural. The investigators' preliminary research indicates that greenwashing tactics may inaccurately convey modified product risk to consumers. The overarching objective of this project is to test the effect of greenwashing methods used by cigarette companies to market products on actual smoking behavior in a controlled laboratory study. The investigators' proposed research focuses on young adults (age 18-29), because this is a key age for smoking initiation and escalation, and research has found that young adults may be more susceptible than older adults to greenwashing in cigarette ads. This study will test the effect of greenwashing on behavioral economic demand and smoking topography in a laboratory-controlled cigarette self-administration study. These data will clearly connect tobacco advertising features to product risk perceptions and actual smoking behavior. This work will provide FDA with an integrated set of evidence that identifies misleading greenwashing tactics that inaccurately convey modified product risk which can be used to inform regulatory action regarding restrictions of this type of advertising.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Smoking sessions | Experimental | This is the single arm that will go through cigarette smoking sessions |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Smoking sessions | Behavioral | Participants undergo topography and behavioral economic sessions where they can make choices to earn cigarette puffs by pulling plungers on experimental equipment |
| Measure | Description | Time Frame |
|---|---|---|
| Demand Intensity as Assessed by a Behavioral Economic Demand Curve | Number of cigarette puff bouts smoked at no cost as measured by a demand curve | Through study completion, an average of 2 weeks |
| Demand Elasticity as Assessed by a Behavioral Economic Demand Curve | Sensitivity of cigarette consumption to changes in cost for cigarettes | Through study completion, an average of 2 weeks |
| Cross-price Elasticity Coefficients as Assessed by a Behavioral Economic Demand Curve | Sensitivity of cigarette consumption to changes in cost for alternative products as a linear slope. | Through study completion, an average of 2 weeks |
| Change in Total Puff Volume as Measured by a Smoking Topography Machine | Total cigarette puff volume in milliliters (mls) | Days 2 and 3 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Matthew W Johnson, Ph.D. | Professor | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Behavioral Pharmacology Research Unit | Baltimore | Maryland | 21224 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Greenwashing and Control Advertising | This is the single arm that will go through 9 cigarette smoking sessions. Participants complete 9 experimental sessions in which they see concurrently presented greenwashing and control advertisements for cigarettes. Data are from those 9 sessions. Smoking sessions: Participants undergo topography and behavioral economic sessions where they can make choices to earn cigarette puffs by pulling plungers on experimental equipment. There is a within-session randomization to earn greenwashing versus control advertised cigarettes. Both conditions were present in each session with variations in cost. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Smoking Sessions | This is the single arm that will go through cigarette smoking sessions Smoking sessions: Participants undergo topography and behavioral economic sessions where they can make choices to earn cigarette puffs by pulling plungers on experimental equipment |
| 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 | Demand Intensity as Assessed by a Behavioral Economic Demand Curve | Number of cigarette puff bouts smoked at no cost as measured by a demand curve | Participants that completed the study | Posted | Mean | Standard Deviation | puff bouts | Through study completion, an average of 2 weeks |
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Up to 2 months
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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 | Smoking Sessions | This is the single arm that will go through cigarette smoking sessions Smoking sessions: Participants undergo topography and behavioral economic sessions where they can make choices to earn cigarette puffs by pulling plungers on experimental equipment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Matthew Johnson | Johns Hopkins University | 410-550-0056 | mwj@jhu.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 | Feb 18, 2023 | Mar 31, 2025 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D000073869 | Tobacco Smoking |
| ID | Term |
|---|---|
| D012907 | Smoking |
| D001519 | Behavior |
| D064424 | Tobacco Use |
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| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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|
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| Primary | Demand Elasticity as Assessed by a Behavioral Economic Demand Curve | Sensitivity of cigarette consumption to changes in cost for cigarettes | Data could not be summarized for elasticity measures due to lack of non-zero responding at higher prices on the demand curve. | Posted | Through study completion, an average of 2 weeks |
|
|
| Primary | Cross-price Elasticity Coefficients as Assessed by a Behavioral Economic Demand Curve | Sensitivity of cigarette consumption to changes in cost for alternative products as a linear slope. | Participants that completed the study | Posted | Mean | Standard Deviation | slope | Through study completion, an average of 2 weeks |
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| Primary | Change in Total Puff Volume as Measured by a Smoking Topography Machine | Total cigarette puff volume in milliliters (mls) | Participants that completed the study | Posted | Mean | Standard Error | mLs | Days 2 and 3 |
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|
| 0 |
| 37 |
| 0 |
| 37 |
| 0 |
| 37 |
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