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

Bethany Shorey Fennell

Status: Completed

Conditions: Cigarette Use; Tobacco Use

Treatments: Behavioral: Restriction on characterizing flavors in combustible nicotine products; Behavioral: Restriction on characterizing flavors in noncombustible nicotine products; Behavioral: Reduced nicotine regulatory environment

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT06988371

99596

5U54DA058256-02 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 695 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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:

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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695 participants in 2 patient groups

Daily smoking

Experimental group

Description:

Participants who smoke cigarettes every day

Treatment:

Behavioral: Reduced nicotine regulatory environment

Behavioral: Restriction on characterizing flavors in noncombustible nicotine products

Behavioral: Restriction on characterizing flavors in combustible nicotine products

Nondaily smoking

Experimental group

Description:

Participants who smoke cigarettes some days but not every day in a month

Treatment:

Behavioral: Reduced nicotine regulatory environment

Behavioral: Restriction on characterizing flavors in noncombustible nicotine products

Behavioral: Restriction on characterizing flavors in combustible nicotine products