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.

Study Overview

• Status: Completed
• Conditions: Tobacco Smoking
• Intervention / Treatment: Behavioral: Smoking sessions

• Study Type: Interventional
• Enrollment (Actual): 37
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Maryland
    • Baltimore, Maryland, United States, 21224
      • Behavioral Pharmacology Research Unit

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 29 years (Adult)
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Smoking sessions; This is the single arm that will go through cigarette smoking sessions	Behavioral: Smoking sessions; Participants undergo topography and behavioral economic sessions where they can make choices to earn cigarette puffs by pulling plungers on experimental equipment

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: Johns Hopkins University
• Collaborators: National Institute on Drug Abuse (NIDA)
• Investigators: Principal Investigator: Matthew W Johnson, Ph.D., Professor

Study record dates

Study Major Dates

• Study Start (Actual): August 18, 2021
• Primary Completion (Actual): March 22, 2024
• Study Completion (Actual): March 22, 2024

Study Registration Dates

• First Submitted: October 14, 2020
• First Submitted That Met QC Criteria: October 19, 2020
• First Posted (Actual): October 20, 2020

Study Record Updates

• Last Update Posted (Actual): June 15, 2025
• Last Update Submitted That Met QC Criteria: May 22, 2025
• Last Verified: May 1, 2025

More Information

Terms related to this study

• Other Study ID Numbers: IRB00264306; R01DA049814 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No