Effect of Product Characteristics on the Abuse Liability of Nicotine Pouches
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 84
- 试验地点
- 2
- 主要终点
- Abuse liability: Amount of time with Nicotine product
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- None
盲法说明
Participant and Investigator will remain blinded to the intervention dose and pH
入排标准
- 年龄范围
- 21 Years 至 35 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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.
结局指标
主要结局
Abuse liability: Amount of time with Nicotine product
时间窗: Visit 1, Visit 2, Visit 3, Visit 4 (all visits within 2-4 weeks)
Total amount of time with Nicotine Pouches in mouth (excluding periods in between NPs after disposal)
Abuse liability: Number of Nicotine Pouches used
时间窗: Visit 1, Visit 2, Visit 3, Visit 4 (all visits within 2-4 weeks)
Total number of Nicotine Pouches used (i.e., larger number and longer time with Nicotine Pouches, higher abuse ability.
Subjective effects measures: Drug Effects Questionnaire
时间窗: Visit 1, Visit 2, Visit 3, Visit 4 (all visits within 2-4 weeks)
During the session, participants will also repeatedly (every 30 min) complete the subjective effects measures of abuse liability of NP (using VAS), which will be developed based on the Drug Effects Questionnaire (DEQ). A modified version of the DEQ will be used to rate acute responses to the NP on the Visual Analogue Scale (range, 0-100). Items assess liking/wanting (e.g., "I enjoy nicotine buzz," "I feel good effects from the NP," "I want more," "I feel the NP strength," and "I like the NP effect").
Subjective effects measures: Modified Cigarette Evaluation Questionnaire
时间窗: Visit 1, Visit 2, Visit 3, Visit 4 (all visits within 2-4 weeks)
Modified Cigarette Evaluation Questionnaire will also be used to measure domains of subjective reinforcing effects (product satisfaction, psychological reward; e.g., "NP is satisfying" on a 7-point scale (0-7).
Product appeal
时间窗: Visit 1, Visit 2, Visit 3, Visit 4 (all visits within 2-4 weeks)
After each administration, participants will use visual analogue scales (VAS, 0-100 range) to rate the product they just used: (1) "How much did you like the product?" (liking); (2) "How much did you dislike the product?" (disliking); and (3) "Would you use the product again?" (use again). A composite appeal score will also be calculated by averaging the 3 appeal ratings (Cronbach's α will be estimated to assess scale reliability; disliking will be reverse-scored).
Sensory Attribute
时间窗: Visit 1, Visit 2, Visit 3, Visit 4 (all visits within 2-4 weeks)
Participants will answer following sensory quality questions: (1) "How sweet was the product?"; (2) smooth?; (3) bitter?; and (4) harsh? (VAS 0-100, "Not at all" to "Extremely". Burning and tingling sensation will be measured at each trial.
次要结局
- Nicotine product use history: Number of days(past 30-day)
- Nicotine product use history: Number of Nicotine product(past 30-day)
- Nicotine product use history: Amount of time with Nicotine product(past 30-day)
- Nicotine Pouches brand(past 30-day)
- Number of e- cigarettes(past 30-day)
- Tobacco use(past 30-day)
研究者
Dae Hee Han
Assistant Professor
Emory University