Effect of Nicotine Pouches on The Underlying Normal Electrocardiogram

Not Applicable

• Conditions: Heart Rate; ECG; Vital Sign Monitoring; Symptoms

• Registration Number: NCT07057440
• Lead Sponsor: Ekim Seven

Brief 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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-06
• Study First Submitted: 2025-06-10
• Study Start: 2025-06-27
• Study First Submitted QC: 2025-07-04
• Last Update Submitted: 2025-07-04
• Study First Posted: 2025-07-09
• Last Update Posted: 2025-07-09
• Primary Completion: 2025-09
• Study Completion: 2025-12-01

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

• 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

Exclusion Criteria

• 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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Primary Outcome Measures

Name	Time	Method
Heart rate	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.

Secondary Outcome Measures

Name	Time	Method
ECG parameters	10 and 20 minutes (just before disposal) after the placement of the nicotine pouch in the oral cavity	Changes in various ECG parameters from baseline: • PR interval (msec); • QRS duration (msec); • QT interval (corrected, QTc) (msec); • HRV (msec)
ST-T segment changes	10 and 20 minutes (just before disposal) after the placement of the nicotine pouch in the oral cavity	ST-T segment changes, e.g., depression/elevation/inversion (mm) from baseline
Arrhythmias	10 and 20 minutes (just before disposal) after the placement of the nicotine pouch in the oral cavity	Any arrhythmias e.g., ectopic beats (yes/no, numerical) detected on the ECG compared with baseline ECG

Trial Locations

Locations (1)

Department of cardiology, Copenhagen University Hospital, Amager & Hvidovre; 🇩🇰 Hvidovre, Denmark