Survey to Test the Nicotine Concentration and Nicotine Flux Labels for E-cigarettes

Официальное название

Using Novel Labeling to Improve Public Understanding of Nicotine in Electronic Nicotine Delivery Systems (ENDS): Nicotine Concentration and Nicotine Flux

Обзор

Current labels for the nicotine in e-cigarette/vaping products do not sufficiently convey information to the public. The aims of this study include developing and validating two new types of labels for the nicotine in vaping products: nicotine concentration and nicotine flux (reflecting nicotine emissions). Investigators will survey youth (ages 14-20) and adults (ages 21+ \[21 is the legal age to purchase tobacco products in the U.S.\]) to evaluate the utility of several new labels investigators have developed.

Подробное описание

The primary goal of the proposed study is to improve labeling of the nicotine in e-cigarettes so that both youth and adults better understand the nicotine strength of these products. Aims include: 1) developing a universally-applicable nicotine concentration label that provides more information than does current market labeling, and 2) examining the utility of labeling nicotine flux (i.e., the nicotine produced through the product mouthpiece) for closed-system e-cigarettes relative to current market labeling and the new nicotine concentration labeling.

This study has three primary objectives. First, to produce an optimized nicotine concentration label that could be used to replace current FDA-mandated nicotine concentration labeling for all ENDS. Second, to develop optimized nicotine flux labeling for closed-system devices for which flux values are readily calculatable. Third, to compare the optimized nicotine concentration and flux labels to one another to determine if there is added value of including flux labeling on closed system devices. Given that flux labels have never been developed before, the proposed study will be the first to speak to their potential utility.

Вмешательства

• Другое Updated Labeling
  Flux based nicotine labeling.

Первичные конечные точки

• Perceived Nicotine Strength [Срок оценки: 20 minutes]

Вторичные конечные точки (2)

• Perceived Addictiveness [Срок оценки: 20 minutes]
• Rank ordering of all labels on their ability to accurately convey information about nicotine strength [Срок оценки: 20 minutes]

Критерии участия

Критерии включения

• Youth\* (14-20 years) or an adults (21 years and older)

• The legal age for purchasing tobacco in the U.S. is 21 years. Therefore, ages for youth and adults were split at the legal age for purchase.
• Resides in the United States
• Reports no history of tobacco product use (25% of the youth and adult samples, respectively) or past-month use of e-cigarettes (but not cigarettes; 25%), cigarettes (but not e-cigarettes; 25%), or both e-cigarettes and cigarettes (25%).

Критерии исключения

• Children under 14 years

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

Простое слепое

Основная цель

Другое

Центры проведения

США · 1 центр

• Connecticut Mental Health Center — New Haven

Идентификаторы

NCT: NCT07553585 · 2000042504 · 1R01DA059573-01A1

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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