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Набор по приглашению NCT06234722

Modeling Tobacco Regulatory Impacts in Appalachia Using the Experimental Tobacco Marketplace

Без фазы С лечением Tobacco Use Cigarette Use

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Very Low Nicotine Cigarette, Reduced nicotine regulatory environment, Restriction on characterizing flavors in combustible nicotine products, Restriction on characterizing flavors in noncombustible nicotine products.
Кому может быть актуально
Состояния в реестре: Tobacco Use, Cigarette Use. Базовые параметры: от 21 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
США
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

Обзор

The goal of this project is to look at the effect of proposed tobacco product regulations in Appalachian Kentucky. Appalachian Kentucky is a diverse and underserved rural area that would benefit from more tobacco regulation research. Researchers will study the effects of three proposed tobacco product regulations among users of tobacco products in Appalachian KY. Researchers will also study how degree of rurality effects how those regulations impact behavior. Participants will be asked to complete online surveys and tests, online shopping sessions in a simulated Experimental Tobacco Marketplace, and track their tobacco product use throughout the 9-week experiment.

Подробное описание

After granting informed consent, participants will complete a baseline assessment session. This will be followed by an extended 9-week sampling period to acclimate participants to their randomly assigned experimental cigarette and allow any shifts in product consumption patterns to materialize. In the final week of this sampling period, participants will complete behavioral assessments and a series of assessments to assess the impact of potential regulatory environments relevant to our aims.

Experimental Tobacco Marketplace. In this procedure, participants will complete purchasing scenarios in our 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 an online marketplace with an interface similar to many online merchants. This will allow participants to browse through the selection of 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. Tobacco and nicotine products will match the products found by surveying product availability vendors in the local communities. 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 we have shown to generate realistic results. They will use that virtual budget to indicate which selection of products they would purchase from those available in the marketplace.

Baseline Assessment Session. The first experimental session will be an assessment session to collect information from participants on substance use patterns and addiction severity, as well as the results of behavioral and cognitive tasks that have measure components of our behavioral economic model of product valuation.

Sampling Period. After their assessment session, participants will be given a supply of their randomly assigned reduced-nicotine cigarette corresponding to two weeks of their typical cigarette consumption and asked to use the provided cigarettes as their only combusted tobacco product for 9 consecutive weeks.

Вмешательства

  • Препарат Very Low Nicotine Cigarette
    Participants will be assigned to one of two investigational cigarette nicotine levels for the duration of the experiment: 0.4mg/g or 15.8mg/g
  • Поведенческое Reduced nicotine regulatory environment
    In this regulatory environment, participants' usual combustible cigarette will not be available in the Experimental Tobacco Marketplace and only the participants' assigned investigational cigarette 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. Only 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. Only 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: Assessed at study week 0 and at study week 9]
  • Aggregate behavioral economic substitution across all participants under the proposed regulatory environments [Срок оценки: Assessed at study week 0 and at study week 9]
Вторичные конечные точки (11)
  • Timeline Follow-Back (TLFB): Average of marijuana and nicotine use quantity [Срок оценки: Assessed at study week 0 and at study week 9]
  • Fagerström Test for Nicotine Dependence (FTND) [Срок оценки: Assessed at study week 0 and at study week 9]
  • Minnesota Nicotine Withdrawal Scale (MNWS) [Срок оценки: Assessed at study week 0 and at study week 9]
  • Hypothetical quantity purchased in purchase tasks [Срок оценки: Assessed at study week 0 and at study week 9]
  • Delay Discounting Tasks [Срок оценки: Assessed at study week 0 and at study week 9]
  • Activity Level Questionnaire - Substance Use Version (ALQ-SUV) [Срок оценки: Assessed at study week 0 and at study week 9]
  • Breath Carbon Monoxide (CO) [Срок оценки: Collected twice daily through the 10 week duration of the study]
  • Salivary Cotinine [Срок оценки: Collected with assessment sessions at study weeks 0 and 9, as well as twice weekly remotely during interim sampling period]
  • Self-reported nicotine product use [Срок оценки: Collected daily from study week 1 to study week 9]
  • Self-reported withdrawal symptom severity [Срок оценки: Collected daily from study week 1 to study week 9]
  • Self-reported nicotine craving intensity [Срок оценки: Collected daily from study week 1 to study week 9]

Критерии участия

Критерии включения

  • At least 21 years old
  • Consume nicotine and/or tobacco products daily
  • Have no plans to quit nicotine/tobacco consumption or seek treatment in the subsequent 9 weeks
  • 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
Перекрёстный дизайн
Маскирование
Двойное слепое
Основная цель
Другое

Центры проведения

США · 1 центр
  • University of Kentucky — Lexington

Идентификаторы

NCT: NCT06234722 · 87440 · 1U54DA058256-01

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗