Menu
Enrolling by invitation NCT06988371

Responses of Adults Smoking Nondaily and Daily in the Experimental Tobacco Marketplace

No phase Interventional Tobacco Use Cigarette Use

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Reduced nicotine regulatory environment, Restriction on characterizing flavors in combustible nicotine products, Restriction on characterizing flavors in noncombustible nicotine products.
Who it may be relevant to
Registry conditions: Tobacco Use, Cigarette Use. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Overview

The goal of this project is to learn about the potential impact of tobacco regulations that could affect the availability of tobacco products among adults who smoke nondaily and daily. Nondaily smoking is increasingly common and tobacco regulation research should consider how FDA actions may impact this group. Participants will be asked to complete online surveys and tests, online shopping sessions in a simulated Experimental Tobacco Marketplace. Reactions and decisions of adults who smoke nondaily and daily will be compared.

Detailed description

After granting informed consent, participants will complete the single assessment.

First, investigators will collect information from participants on personal characteristics, substance use patterns and addiction severity, and behavioral and cognitive tasks that measure components of our behavioral economic model of product valuation.

Experimental Tobacco Marketplace. In this procedure, participants will complete purchasing scenarios in a realistic tobacco/nicotine product marketplace to model and examine the impact of each of the proposed tobacco product regulations. Participants will be seated in front of a computer to access a simulated online tobacco marketplace with an interface similar to many online merchants. This will allow participants to browse through the selection of tobacco products and add as many as they desire of each product to the virtual shopping cart. Each product will have the price clearly displayed along with an image and description of the product. The selection of products will vary based on the particular regulatory scenario that is being modeled. In each pricing scenario during each marketplace session, participants will be asked to make nicotine-product purchases sufficient for one week's use from this marketplace. During a purchasing session, the participant will be provided with a virtual budget that matches their actual weekly budget for nicotine/tobacco products, a procedure our team has shown to generate realistic results. Participants will use that virtual budget to indicate which selection of products they would purchase from those available in the marketplace.

Interventions

  • Behavioral Reduced nicotine regulatory environment
    In this regulatory environment, participants' usual combustible cigarette will not be available in the Experimental Tobacco Marketplace and reduced nicotine content cigarettes will be the only available combustible cigarette.
  • Behavioral Restriction on characterizing flavors in combustible nicotine products
    In this regulatory environment, menthol and other characterizing flavors in combustible nicotine products will not be available in the Experimental Tobacco Marketplace. Tobacco- or no-flavored combustible nicotine products will be the only combustible nicotine products available.
  • Behavioral Restriction on characterizing flavors in noncombustible nicotine products
    In this regulatory environment, menthol and other characterizing flavors in noncombustible nicotine products will not be available in the Experimental Tobacco Marketplace. Tobacco- or no-flavored noncombustible nicotine products will be the only noncombustible nicotine products available.

Primary outcome measures

  • Aggregate behavioral economic demand across all participants under the proposed regulatory environments [Time frame: Baseline]
  • Aggregate behavioral economic substitution across all participants under the proposed regulatory environments [Time frame: Baseline]
Secondary outcome measures (2)
  • Hypothetical quantity purchased in purchase tasks [Time frame: Baseline]
  • Delay Discounting Tasks [Time frame: Baseline]

Eligibility criteria

Inclusion criteria

  • At least 18 years old
  • Consume cigarettes 4-30 days per month
  • Have no plans to quit nicotine/tobacco products
  • Read and understand English

Exclusion criteria

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Other

Study locations

United States · 1 center
  • University of Kentucky — Lexington

Identifiers

NCT: NCT06988371 · 99596 · 5U54DA058256-02

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗