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

NCT ID: NCT06988371

Last Updated: 2025-10-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

695 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-08-18

Study Completion Date

2025-08-29

Brief Summary

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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

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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.

Conditions

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Tobacco Use Cigarette Use

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Mixed crossover-factorial
Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Daily smoking

Participants who smoke cigarettes every day

Group Type EXPERIMENTAL

Reduced nicotine regulatory environment

Intervention Type BEHAVIORAL

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.

Restriction on characterizing flavors in combustible nicotine products

Intervention Type BEHAVIORAL

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.

Restriction on characterizing flavors in noncombustible nicotine products

Intervention Type BEHAVIORAL

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.

Nondaily smoking

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

Group Type EXPERIMENTAL

Reduced nicotine regulatory environment

Intervention Type BEHAVIORAL

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.

Restriction on characterizing flavors in combustible nicotine products

Intervention Type BEHAVIORAL

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.

Restriction on characterizing flavors in noncombustible nicotine products

Intervention Type BEHAVIORAL

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.

Interventions

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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.

Intervention Type 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.

Intervention Type 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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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National Institute on Drug Abuse (NIDA)

NIH

Sponsor Role collaborator

Bethany Shorey Fennell

OTHER

Sponsor Role lead

Responsible Party

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Bethany Shorey Fennell

Assistant Professor

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Bethany Shorey Fennell, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Kentucky

Locations

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University of Kentucky

Lexington, Kentucky, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Informed Consent Form

View Document

Other Identifiers

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5U54DA058256-02

Identifier Type: NIH

Identifier Source: secondary_id

View Link

99596

Identifier Type: -

Identifier Source: org_study_id

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