Effect of Nicotine Pouches on The Underlying Normal Electrocardiogram
NCT ID: NCT07057440
Last Updated: 2025-12-11
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
20 participants
INTERVENTIONAL
2025-06-27
2025-10-31
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
PREVENTION
QUADRUPLE
Study Groups
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Placebo pouch arm
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.
Low-dosage nicotine pouch arm
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.
High-dosage nicotine pouch arm
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.
Interventions
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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.
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.
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.
Eligibility Criteria
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Inclusion Criteria
* 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
* Medications affecting cardiac conduction or autonomic function (e.g., antiarrhythmic drugs).
* Pregnancy or breastfeeding.
* Current illness or infection.
* History of substance abuse.
18 Years
70 Years
ALL
Yes
Sponsors
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Ekim Seven
OTHER
Responsible Party
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Ekim Seven
Cardiologist, PhD, clinical associate professor, department of cardiology, Hvidovre University Hospital
Locations
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Department of cardiology, Copenhagen University Hospital, Amager & Hvidovre
Hvidovre, , Denmark
Countries
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Other Identifiers
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H-25018523
Identifier Type: -
Identifier Source: org_study_id
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