Cigarette Smoking Decision Study

NCT04595279 | Completed Results

• 2 other identifiers: IRB00264306R01DA049814
• Study Type: interventional
• Target: 37
• Locations: 1 country
• Sites: 1

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.

Conditions

Tobacco Smoking

Outcome Measures

Primary Outcomes (4)

• 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

Study Arms (1)

Smoking sessions

EXPERIMENTAL

This is the single arm that will go through cigarette smoking sessions

Behavioral: Smoking sessions

Interventions

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

Smoking sessions

Eligibility Criteria

• Age: 18 Years - 29 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Johns Hopkins University: lead
• National Institute on Drug Abuse (NIDA): collaborator

Study Sites (1)

Behavioral Pharmacology Research Unit

Baltimore, Maryland, 21224, United States

Location

MeSH Terms

Conditions

Tobacco Smoking

Condition Hierarchy (Ancestors)

Smoking; Behavior; Tobacco Use

Results Point of Contact

• Title: Matthew Johnson
• Organization: Johns Hopkins University

mwj@jhu.edu

410-550-0056

Study Officials

• Matthew W Johnson, Ph.D.

  Professor

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 14, 2020
• First Posted: October 20, 2020
• Study Start: August 18, 2021
• Primary Completion: March 22, 2024
• Study Completion: March 22, 2024
• Last Updated: June 15, 2025
• Results First Posted: June 15, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)