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

Обзор

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.

Подробное описание

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.

Вмешательства

• Поведенческое 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.
• Поведенческое 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.
• Поведенческое 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.

Первичные конечные точки

• Aggregate behavioral economic demand across all participants under the proposed regulatory environments [Срок оценки: Baseline]
• Aggregate behavioral economic substitution across all participants under the proposed regulatory environments [Срок оценки: Baseline]

Вторичные конечные точки (2)

• Hypothetical quantity purchased in purchase tasks [Срок оценки: Baseline]
• Delay Discounting Tasks [Срок оценки: Baseline]

Критерии участия

Критерии включения

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

Критерии исключения

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Другое

Центры проведения

США · 1 центр

• University of Kentucky — Lexington

Идентификаторы

NCT: NCT06988371 · 99596 · 5U54DA058256-02

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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