Cigar Legislation and Regulation in Tobacco for the Young (Project CLARITY)

Официальное название

Addiction Potential, Flavoring Content, and Substitutability of Concept Flavored Cigarillos

Обзор

This clinical trial will recruit young adults who currently use cigarillos and examine the smoking behavior and perceptions of different flavored cigarillos, product ingredients/additives impacting these perceptions, and simulated tobacco use outcomes (quitting, switching) in various policy scenarios where different types of flavors are available on the market.

Подробное описание

This clinical trial will isolate the unique effects of concept descriptors on increased cigarillo use and appeal among experienced young adult cigarillo users. The study will seek to determine the addiction potential of concept flavored cigarillos by examining associations of cigarillo flavor type (concept, characterizing, tobacco) and cigarillo flavoring additives/ingredients to complementary measures of product appeal: subjective effects (e.g., satisfaction, reward, taste), actual smoking behavior (e.g., number of puffs), and simulated cigarillo purchasing, other tobacco product substitution, or quitting under different flavor ban scenarios via an Experimental Tobacco Marketplace (ETM).

Вмешательства

• Другое Cigarillo brand 1
  Participants will be assessed on puffing behavior, subjective effects, and exhaled carbon monoxide when assigned to using one of three cigarillo brands. Additives and ingredients of the cigarillo used will also be assessed
• Другое Cigarillo brand 2
  Participants will be assessed on puffing behavior, subjective effects, and exhaled carbon monoxide when assigned to using one of three cigarillo brands. Additives and ingredients of the cigarillo used will also be assessed
• Другое Cigarillo brand 3
  Participants will be assessed on puffing behavior, subjective effects, and exhaled carbon monoxide when assigned to using one of three cigarillo brands. Additives and ingredients of the cigarillo used will also be assessed

Первичные конечные точки

• Puff number [Срок оценки: From enrollment to the end of the final smoking visit, approximately 2 weeks]
• Subjective reward from smoking [Срок оценки: From enrollment to the end of the final smoking visit, approximately 2 weeks]

Критерии участия

Критерии включения

• Ages 18 to 24
• Report past 30-day use of a cigarillo
• Ability to read English at least an 8th grade level
• No immediate plans to quit using tobacco
• At least 1 prior experience with a flavored tobacco product
• U.S. Citizen or permanent resident of the United States.

Критерии исключения

• Current use of smoking cessation pharmacotherapy or nicotine replacement therapy;
• Pregnant, planning to become pregnant, or currently breastfeeding;
• Past or current clinically significant heart disease or hypertension, or other smoking-related disease that could preclude successful study completion;
• Inability to abstain from nicotine/tobacco products for at least 12 hours
• Unwillingness to use the research cigarillos in the lab

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

Открытое

Основная цель

Фундаментальное исследование

Центры проведения

США · 2 центра

• University of Oklahoma Health Campus — Oklahoma City
• West Virginia University — Morgantown

Идентификаторы

NCT: NCT07162935 · Clarity · R01DA062632-01

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗