NCT07057440

Effect of Nicotine Pouches on The Underlying Normal Electrocardiogram

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: Ekim Seven · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Accepted

Summary

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.

Conditions

• Heart Rate
• ECG
• Vital Sign Monitoring
• Symptoms

Interventions

Type	Name	Description
OTHER	High-dose Nicotine Pouch	A High Dose Nicotine Pouch are placed and held in the oral cavity (between the gum and lip) for 20 minutes, as per standard use instructions. After 20 minutes pouches are removed from the oral cavity and disposed.
OTHER	Low Dose Nicotine Pouch	A Low Dose Nicotine Pouch are placed and held in the oral cavity (between the gum and lip) for 20 minutes, as per standard use instructions. After 20 minutes pouches are removed from the oral cavity and disposed.
OTHER	Placebo Pouch	A Placebo Pouch are placed and held in the oral cavity (between the gum and lip) for 20 minutes, as per standard use instructions. After 20 minutes pouches are removed from the oral cavity and disposed.

Timeline

• Start date: 2025-06-27
• Primary completion: 2025-10-31
• Completion: 2025-10-31
• First posted: 2025-07-09
• Last updated: 2025-12-11

Locations

1 site across 1 country: Denmark