Cigarette Smoking Decision Study

Sponsor

Johns Hopkins University (Other)

Overall Status

Recruiting

CT.gov ID

NCT04595279

Collaborator

National Institute on Drug Abuse (NIDA) (NIH)

Enrollment

Location

Arm

23.4

Anticipated Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Tobacco Smoking	Behavioral: Smoking sessions	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

47 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Basic Science

Official Title:

Cigarette Smoking Decision Study

Actual Study Start Date :

Aug 18, 2021

Anticipated Primary Completion Date :

Jul 31, 2023

Anticipated Study Completion Date :

Jul 31, 2023

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Demand intensity as assessed by a behavioral economic demand curve [Through study completion, an average of 2 weeks]
Number of cigarettes 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
Change in total puff volume as measured by a smoking topography machine [Days 2 and 3]
Total cigarette puff volume in milliliters.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 29 Years

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Behavioral Pharmacology Research Unit	Baltimore	Maryland	United States	21224

Sponsors and Collaborators

Johns Hopkins University
National Institute on Drug Abuse (NIDA)

Investigators

Principal Investigator: Matthew W Johnson, Ph.D., Professor

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Johns Hopkins University

ClinicalTrials.gov Identifier:

NCT04595279

Other Study ID Numbers:

IRB00264306
R01DA049814

First Posted:

Oct 20, 2020

Last Update Posted:

Sep 21, 2021

Last Verified:

Sep 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Study Results

No Results Posted as of Sep 21, 2021