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临床试验/NCT07057440
NCT07057440已完成不适用

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

Ekim Seven1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2025年6月27日最近更新:
适应症
干预措施

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

Experimental

干预措施: Low Dose Nicotine Pouch (Other)

High-dosage nicotine pouch arm

Experimental

干预措施: High-dose Nicotine Pouch (Other)

Placebo pouch arm

Placebo Comparator

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

发起方
Ekim Seven
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Ekim Seven

Cardiologist, PhD, clinical associate professor, department of cardiology, Hvidovre University Hospital

Hvidovre University Hospital

研究点 (1)

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