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OpenTrials
Completed

NCT Number: NCT04595279

Cigarette Smoking Decision Study

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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Key information

Conditions

Tobacco Smoking Behavior Smoking Tobacco Use

Age range

18 year–29 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Behavioral Pharmacology Research Unit

Baltimore, Maryland, 21224, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Primary outcomes

  1. Demand Intensity as Assessed by a Behavioral Economic Demand Curve

    Time frame: Through study completion, an average of 2 weeks

    Number of cigarette puff bouts smoked at no cost as measured by a demand curve

  2. Demand Elasticity as Assessed by a Behavioral Economic Demand Curve

    Time frame: Through study completion, an average of 2 weeks

    Sensitivity of cigarette consumption to changes in cost for cigarettes

  3. Cross-price Elasticity Coefficients as Assessed by a Behavioral Economic Demand Curve

    Time frame: Through study completion, an average of 2 weeks

    Sensitivity of cigarette consumption to changes in cost for alternative products as a linear slope.

  4. Change in Total Puff Volume as Measured by a Smoking Topography Machine

    Time frame: Days 2 and 3

    Total cigarette puff volume in milliliters (mls)

Sponsors and collaborators

Lead sponsor

Johns Hopkins University

Other

Collaborators

  • National Institute on Drug Abuse (NIDA)

Registry information

Important dates

Study start
2021
Primary completion
2024
Study completion
2024
First posted
Oct 20, 2020
Registry last updated
Jun 15, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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