Effect of Nicotine Pouches on The Underlying Normal Electrocardiogram A Double-Blinded, Placebo-Controlled Cross-over Study Exploring the Dose-Response Effects of Nicotine Pouches on Heart Rate and the Electrocardiogram ACRONYM: The NICOTUNE Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Heart rate
研究概览
简要总结
Nicotine pouches (NPs) are increasingly being used by children, adolescents, and adults, and are often presented as a less harmful alternative to, for example, smoking. The ability to use these products discreetly (unlike smoking) makes them an attractive option for individuals who wish to avoid the stigma that smokers may sometimes experience.
Nicotine is a well-known addictive substance that affects many organ systems, including the heart and circulatory system. The amount of nicotine in NPs varies greatly, but the pouches can contain large amounts of nicotine compared to the content of a single cigarette. While many studies have previously examined the effects of smoking and other nicotine products on the heart and circulatory system, specific data on the effects of NPs on these same systems are rather limited.
In light of the above, the investigators have planned a study to investigate whether NPs affect the circulatory system and heart rate, assessed through electrocardiography (ECG) and vital signs (i.e., pulse, blood pressure, respiratory rate, and more).
The investigators hypothesis is that the nicotine content in NPs leads to notable changes in the aforementioned measurements and could therefore potentially be associated with an increased health risk.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 70 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Adults aged 18-70 years.
- •Regular (defined as daily) or occasional (generally defined as nondaily) nicotine users (e.g., cigarettes, vaping, or nicotine pouches).
- •Willingness to abstain from nicotine, caffeine (including caffeine containing energy drinks), and alcohol for 6 hours prior to the session
排除标准
- •History of cardiovascular conditions.
- •Medications affecting cardiac conduction or autonomic function (e.g., antiarrhythmic drugs).
- •Pregnancy or breastfeeding.
- •Current illness or infection.
- •History of substance abuse.
研究组 & 干预措施
Low-dosage nicotine pouch arm
干预措施: Low Dose Nicotine Pouch (Other)
High-dosage nicotine pouch arm
干预措施: High-dose Nicotine Pouch (Other)
Placebo pouch arm
干预措施: Placebo Pouch (Other)
结局指标
主要结局
Heart rate
时间窗: 10 and 20 minutes (just before disposal) after the placement of the nicotine pouch in the oral cavity
Changes in HR (beats/minute) obtained from an ECG recorded 20 minutes after nicotine pouch administration compared to the baseline ECG.
次要结局
- ECG parameters(10 and 20 minutes (just before disposal) after the placement of the nicotine pouch in the oral cavity)
- ST-T segment changes(10 and 20 minutes (just before disposal) after the placement of the nicotine pouch in the oral cavity)
- Arrhythmias(10 and 20 minutes (just before disposal) after the placement of the nicotine pouch in the oral cavity)
研究者
Ekim Seven
Cardiologist, PhD, clinical associate professor, department of cardiology, Hvidovre University Hospital
Hvidovre University Hospital
