Clinical trial NCT04595279: Cigarette Smoking Decision Study
Official title: Cigarette Smoking Decision Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Tobacco Smoking
Lead sponsor: Johns Hopkins University
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
First posted: 2020-10-20
Enrollment: 37
Sex: ALL
Minimum age (years): 18
Maximum age (years): 29
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

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.


Eligibility criteria: 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

Primary outcomes:
measure: Demand Intensity as Assessed by a Behavioral Economic Demand Curve
timeFrame: Through study completion, an average of 2 weeks
measure: Demand Elasticity as Assessed by a Behavioral Economic Demand Curve
timeFrame: Through study completion, an average of 2 weeks
measure: Cross-price Elasticity Coefficients as Assessed by a Behavioral Economic Demand Curve
timeFrame: Through study completion, an average of 2 weeks
measure: Change in Total Puff Volume as Measured by a Smoking Topography Machine
timeFrame: Days 2 and 3
Secondary outcomes:
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Behavioral Pharmacology Research Unit
state: Maryland
Study officials:
affiliation: Professor
name: Matthew W Johnson, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: