Effect of Product Characteristics on the Abuse Liability of Nicotine Pouches

Обзор

The goal of this study is to assess the effects of nicotine concentration and its interplay with pH on sensory experience, product appeal, and abuse liability of NPs among young adults NP users. Primary objective is to assess the effect of variation in nicotine concentration in nicotine pouches (NPs) and its interaction effect with pH level on three proximal outcomes of relevance to regulation: (1) sensory experience, (2) product appeal, and (3) abuse liability of NPs.

Подробное описание

Oral nicotine pouches (NPs) are a rapidly growing segment of nicotine products regulated by the U.S. Food and Drug Administration (FDA). These microfiber pouches contain nicotine but no tobacco leaf, and they dissolve in the mouth without requiring spitting. Between late 2019 and early 2022, NP sales surged from 126 million to 808 million units. Their sleek packaging, concealability, and "tobacco-free" claims have made them particularly appealing to young adults, with recent studies showing that over 10% of young adults reported using NPs in the past 30 days. However, this popularity raises health concerns. NPs deliver nicotine efficiently through buccal absorption, leading to rapid increases in blood nicotine levels, which may contribute to oral toxicity, cardiovascular effects, and nicotine dependence. These factors also elevate the abuse liability of NPs-defined as the likelihood of non-medical use leading to harmful consequences.

The FDA has the authority to impose stricter regulations on products with characteristics that enhance appeal and sensory experience, especially among youth. For instance, the agency has proposed banning menthol cigarettes due to their ability to mask irritation and encourage deeper inhalation of nicotine. Similar regulatory scrutiny is now being applied to emerging products like NPs. One key factor influencing product appeal is nicotine formulation. Free-base nicotine, commonly used in non-combustible products like e-cigarettes (ECs), has aversive effects such as bitterness and airway irritation, especially at high concentrations. To counter this, manufacturers began adding organic acids to convert nicotine into a protonated salt, lowering the product's pH and improving its palatability. This shift not only enhances the sensory experience but also increases the abuse liability of high-nicotine products. Evidence suggests that regulating acid additives or setting minimum pH levels could reduce the appeal of these products. Since NPs also use acid additives to lower pH, they share similar characteristics with ECs that attract young users, underscoring the need for targeted regulatory action.

Вмешательства

• Другое Nicotine pouch: Low dose
  Nicotine pouch: 3-4 mg
• Другое Nicotine pouch: High dose
  Nicotine pouch: 6-8 mg
• Другое Low pH
  Nicotine pouch with low pH level \[\<8.5\]
• Другое High pH
  Nicotine pouch with high pH level \[\>8.5\]

Первичные конечные точки

• Abuse liability: Amount of time with Nicotine product [Срок оценки: Visit 1, Visit 2, Visit 3, Visit 4 (all visits within 2-4 weeks)]
• Abuse liability: Number of Nicotine Pouches used [Срок оценки: Visit 1, Visit 2, Visit 3, Visit 4 (all visits within 2-4 weeks)]
• Subjective effects measures: Drug Effects Questionnaire [Срок оценки: Visit 1, Visit 2, Visit 3, Visit 4 (all visits within 2-4 weeks)]
• Subjective effects measures: Modified Cigarette Evaluation Questionnaire [Срок оценки: Visit 1, Visit 2, Visit 3, Visit 4 (all visits within 2-4 weeks)]
• Product appeal [Срок оценки: Visit 1, Visit 2, Visit 3, Visit 4 (all visits within 2-4 weeks)]
• Sensory Attribute [Срок оценки: Visit 1, Visit 2, Visit 3, Visit 4 (all visits within 2-4 weeks)]

Вторичные конечные точки (6)

• Nicotine product use history: Number of days [Срок оценки: past 30-day]
• Nicotine product use history: Number of Nicotine product [Срок оценки: past 30-day]
• Nicotine product use history: Amount of time with Nicotine product [Срок оценки: past 30-day]
• Nicotine Pouches brand [Срок оценки: past 30-day]
• Number of e- cigarettes [Срок оценки: past 30-day]
• Tobacco use [Срок оценки: past 30-day]

Критерии участия

Критерии включения

• Current established users of nicotine pouches (have used nicotine pouches in the past 30 days \& currently use nicotine pouches every day or someday)
• Positive cotinine test via saliva test strip
• Those who are unmotivated to quit nicotine use
• Read and speak English.
• Poly-users of nicotine pouches, e-cigarettes (e.g., vape ≥20 days/month), and tobacco (e.g., ≥4 cigarettes/day for ≥2 years) will be eligible for participation

Критерии исключения

• Planning to cut down or quit using nicotine in the next 30 days
• Currently pregnant or breastfeeding
• History of stroke, seizures, high blood pressure, heart disease/problems, or cardiovascular disease contraindications for nicotine.

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

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Фундаментальное исследование

Центры проведения

США · 1 центр

• Rollins School of Public Health — Atlanta

Идентификаторы

NCT: NCT07165808 · STUDY00009622 · R00DA058241-03 · 2025P012303

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗