Tobacco Smoking
Conditions
Brief summary
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.
Interventions
BEHAVIORALSmoking sessions
Participants undergo topography and behavioral economic sessions where they can make choices to earn cigarette puffs by pulling plungers on experimental equipment
Sponsors
National Institute on Drug Abuse (NIDA)
Johns Hopkins University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 29 Years
Healthy volunteers
Yes
Inclusion criteria
* Age 18 - 29 years of age * Smoke at least five cigarettes per day * Have an expired carbon monoxide level of more than 8 ppm or a urinary cotinine level of more than 100 ng per milliliter
Exclusion criteria
* The intention to quit smoking in the next 30 days * Report roll your own cigarettes as an exclusive form of smoking * A serious medical or psychiatric disorder or unstable condition * Any positive toxicological screening for illicit drugs other than cannabis will be excluded * Women who are pregnant, plan to become pregnant or are breast-feeding
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Demand Intensity as Assessed by a Behavioral Economic Demand Curve | Through study completion, an average of 2 weeks | Number of cigarette puff bouts smoked at no cost as measured by a demand curve |
| Demand Elasticity as Assessed by a Behavioral Economic Demand Curve | Through study completion, an average of 2 weeks | Sensitivity of cigarette consumption to changes in cost for cigarettes |
| Cross-price Elasticity Coefficients as Assessed by a Behavioral Economic Demand Curve | Through study completion, an average of 2 weeks | Sensitivity of cigarette consumption to changes in cost for alternative products as a linear slope. |
| Change in Total Puff Volume as Measured by a Smoking Topography Machine | Days 2 and 3 | Total cigarette puff volume in milliliters (mls) |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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 | 37 |
| Total | 37 |
Baseline characteristics
| Characteristic | Smoking Sessions |
|---|---|
| Age, Continuous | 28.5 years STANDARD_DEVIATION 4.2 |
| Race (NIH/OMB) American Indian or Alaska Native | 1 Participants |
| Race (NIH/OMB) Asian | 2 Participants |
| Race (NIH/OMB) Black or African American | 14 Participants |
| Race (NIH/OMB) More than one race | 5 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 2 Participants |
| Race (NIH/OMB) White | 13 Participants |
| Sex: Female, Male Female | 27 Participants |
| Sex: Female, Male Male | 10 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 37 |
| other Total, other adverse events | 0 / 37 |
| serious Total, serious adverse events | 0 / 37 |
Outcome results
Primary
Change in Total Puff Volume as Measured by a Smoking Topography Machine
Total cigarette puff volume in milliliters (mls)
Time frame: Days 2 and 3
Population: Participants that completed the study
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Greenwashing and Control Advertising | Change in Total Puff Volume as Measured by a Smoking Topography Machine | Greenwashing Advertising | 1649 mLs | Standard Error 1490 |
| Greenwashing and Control Advertising | Change in Total Puff Volume as Measured by a Smoking Topography Machine | Control Advertising | 1321 mLs | Standard Error 883.7 |
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.
Time frame: Through study completion, an average of 2 weeks
Population: Participants that completed the study
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Greenwashing and Control Advertising | Cross-price Elasticity Coefficients as Assessed by a Behavioral Economic Demand Curve | Greenwashing Advertising | 0.03 slope | Standard Deviation 0.09 |
| Greenwashing and Control Advertising | Cross-price Elasticity Coefficients as Assessed by a Behavioral Economic Demand Curve | Control Advertising | 0.05 slope | Standard Deviation 0.12 |
Primary
Demand Elasticity as Assessed by a Behavioral Economic Demand Curve
Sensitivity of cigarette consumption to changes in cost for cigarettes
Time frame: Through study completion, an average of 2 weeks
Population: Data could not be summarized for elasticity measures due to lack of non-zero responding at higher prices on the demand curve.
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
Time frame: Through study completion, an average of 2 weeks
Population: Participants that completed the study
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Greenwashing and Control Advertising | Demand Intensity as Assessed by a Behavioral Economic Demand Curve | Greenwashing Advertisment | 4.709677419 puff bouts | Standard Deviation 3.588811766 |
| Greenwashing and Control Advertising | Demand Intensity as Assessed by a Behavioral Economic Demand Curve | Control Advertisement | 2.580645161 puff bouts | Standard Deviation 3.442617159 |