Nicotine Flux, a Potentially Powerful Tool for Regulating Nicotine Delivery From Electronic Cigarettes: Significance of Nicotine Flux to the Rate of Nicotine Delivery and Subjective Effect
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 130
- 试验地点
- 2
- 主要终点
- Nicotine Dependence questionnaires - The Fagerstrom Test of Nicotine Dependence
研究概览
简要总结
Electronic nicotine delivery systems (ENDS) heat and vaporize a nicotine-containing liquid to produce an aerosol that can deliver nicotine to the blood and the brain. ENDS use has increased rapidly in the last decade, especially among youth: over 20% of US high school students are current ENDS users, and there is evidence of nicotine dependence in this population. Federal legislation has been proposed that would restrict ENDS liquid nicotine concentration to make ENDS "significantly less addictive and appealing to youth." However, these and other efforts to curb addiction by limiting nicotine liquid concentration are unlikely to succeed because nicotine emissions from ENDS depend on multiple variables. To achieve the intended public health aims, regulations targeting addiction must focus on nicotine delivery, not nicotine concentration. While nicotine delivery cannot be regulated directly, the rate at which an ENDS emits nicotine, the "nicotine flux", can be regulated and, importantly, predicted based on a few device design and operating variables. However, to date there is no empirical evidence demonstrating the relationship between flux and delivery, nor between flux and the subjective effects that support nicotine dependence. Closing this gap is essential for providing an effective framework for regulating ENDS. At the American University of Beirut, the investigators will assess the relationship between nicotine flux, form, and subjective effects. Participants will use ENDS devices with varying nicotine fluxes and forms. Dependency measures, such as urge to smoke, craving, and abstinence, will be assessed. The outcome will indicate the degree to which nicotine flux/form influence subjective effects related to dependency, puffing intensity, and exposure to toxicants. In summary, this project will provide the empirical evidence needed for public health agencies to use nicotine flux as an encompassing and convenient construct to regulate nicotine delivery from ENDS.
详细描述
Assess the influence of nicotine flux and nicotine form on subjective effects. At AUB, the investigators will assess subjective effects (e.g. product liking, nicotine craving) and puffing topography for 130 participants who will undergo 5 ENDS use sessions (combinations 1-5) consisting of 2 bouts (10 puffs + 60min ad libitum) with 2 fluxes (16 and 32μg/s) x 2 forms (protonated, freebase) and a 0 nicotine condition. In addition, the investigators will use a state-of-the-art device to sample in situ a fraction of the aerosol generated during each puff to verify actual nicotine flux and form, and measure exposure to pulmonary toxicants (carbonyls). The investigators hypothesize that increasing nicotine flux and protonated nicotine will result in greater reductions of nicotine craving, and lower puffing intensity and carbonyl exposure. In addition, 10 participants that completed the five use sessions will attend the lab for one additional visit with the aim of determining the influence of puff-by-puff variation of ENDS power and liquid composition on puffing behavior and sensory effects. During this visit participants will complete three directed puffing bouts (10 puffs). In each bout, participants will alternate puffs between two identical ENDS devices differing by a single design factor (combinations 6-8).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Other
- 盲法
- Double (Participant, Investigator)
盲法说明
Each participant will attend the lab for five different visits that differ by nicotine flux and/or form in random order. All sessions will be double-blind (Participant / Investigator). The analytical chemist will be providing the investigator with e-liquid in a random order in each session for each participant.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Must be healthy and above 18 years of age
- •Must be willing to provide informed consent, attend the lab, and abstain from tobacco/nicotine as required (participants will be instructed to abstain from nicotine/tobacco and/or ENDS use for ≥12h)
- •A dual ENDS and tobacco user who reports daily use of ENDS (≥ 3 mg/ml nicotine) or cigarettes (any frequency) AND someday use (≥ 3 days/week) of ENDS (≥ 3 mg/ml nicotine) or cigarettes (any frequency) for the past 3 months or longer
排除标准
- •History of chronic disease or an uncontrolled psychiatric condition
- •History of or active cardiovascular disease, low/high blood pressure, seizures, regular use of a prescription medication (except vitamins/birth control)
- •Past month use of cocaine, opioids, benzodiazepines, or methamphetamines
- •Individuals who report using marijuana >15/30 days
- •Women will be excluded if they are breast-feeding or pregnant
- •Participants intending to quit tobacco/nicotine use in the next 30 days and referred to cessation treatment
结局指标
主要结局
Nicotine Dependence questionnaires - The Fagerstrom Test of Nicotine Dependence
时间窗: Visit 1 - Before starting the first session
The Fagerstrom Test of Nicotine Dependence questionnaires that assesses nicotine dependence on ENDS. General questions not based on a scale.
Subjective Measures of Nicotine Abstinence Symptoms - PROMIS-10 Global Health measures
时间窗: Visit 1 - Before starting the first session
The PROMIS-10 Global Health measures five domains: physical function, fatigue, pain, emotional distress, and social health. 10 Items are rated on a five-point scale (Poor=1, Fair=2, Good=3, Very good=4, Excellent=5) with higher scores indicating higher activity.
Subjective Measures of Nicotine Abstinence Symptoms - The corresponding 4-item Combustible cigarette Dependence
时间窗: Visit 1 - Before starting the first session
The corresponding 4-item Combustible cigarette Dependence Scale that assesses nicotine dependence for daily and nondaily smokers. 4 Items are rated on a five-point scale (Never=1, Rarely=2, Sometimes=3, Often=4, Always=5) with higher scores indicating higher activity.
Subjective Measures of Nicotine Abstinence Symptoms - Drug Effect
时间窗: Up to 180 minutes
The Drug Effect Questionnaire (DEQ) will measure acute effects consisting of seven items: drug strength, high, feeling stimulated, good effects, bad effects, wanting more drugs, and drug liking and this will be assessed on a subjective scale (0-100, not at all-extremely), with higher scores indicating higher effects.
Subjective Measures of Nicotine Abstinence Symptoms - The corresponding 4-item E-Cigarette Dependence
时间窗: Visit 1 - Before starting the first session
The corresponding 4-item E-Cigarette Dependence Scale that assesses dependence on ENDS. 4 Items are rated on a five-point scale (Never=1, Rarely=2, Sometimes=3, Often=4, Almost Always=5) with higher scores indicating higher activity.
Subjective Measures of Nicotine Abstinence Symptoms - Product liking magnitude scale
时间窗: Up to 180 minutes
Product liking will be assessed by the Electronic Cigarette Specific Effects questionnaire, general labeled magnitude scale (gLMS) on a subjective scale (0-100, not at all - extremely), with higher scores indicating higher effects.
Subjective Measures of Nicotine Abstinence Symptoms - Product liking hedonic scale
时间窗: Up to 180 minutes
Product liking will be assessed by the Electronic Cigarette Specific Effects questionnaire, general labeled hedonic scale (LHS) (0-100, most disliked sensation imaginable - most liked sensation imaginable), with higher scores indicating higher effects.
Subjective Measures of Nicotine Abstinence Symptoms - Smoking urges
时间窗: Up to 180 minutes
Smoking urges will be assessed by the smoking urges questionnaire on a subjective scale (0-100, Strongly disagree - strongly agree) with higher scores indicating higher urges.
Subjective Measures of Nicotine Abstinence Symptoms - Hughes and Hatsukami
时间窗: Up to 180 minutes
The Hughes-Hatsukami Withdrawal Questionnaire (HHWQ) will be assessed by the Hughes and Hatsukami 1986 questionnaire on a subjective scale (0-100, Not at all - extremely).
次要结局
- Puff Duration(Will be measured during the approximately 5-minute, 10-puff use bout and 60-minute, ad lib use bout)
- Flow rate(Will be measured during the approximately 5-minute, 10-puff use bout and 60-minute, ad lib use bout)
- Puff Interval(Will be measured during the approximately 5-minute, 10-puff use bout and 60-minute, ad lib use bout)
- Number of Puffs(Will be measured during the approximately 60-minute, ad lib use bout)
- Liquid consumed(Will be measured after the approximately 5-minute, 10-puff use bout and 60-minute, ad lib use bout)
- Carbonyl compound yield(Will be measured after the 60-minute, ad lib use bout)
- Nicotine flux(Will be measured after the approximately 5-minute, 10-puff use bout and 60-minute, ad lib use bout)
- Sensory Feedback - Perceived Mouthful(Will be measured during the approximately 5-minute, 10-puff use bout)
- Sensory feedback - Perceived Draw Effort(Will be measured during the approximately 5-minute, 10-puff use bout)