Department of cardiology, Copenhagen University Hospital, Amager & Hvidovre
Hvidovre, 2650, Denmark
NCT Number: NCT07057440
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.
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Notify Me18 year–70 year
All sexes
Interventional
Not applicable
Hvidovre, 2650, Denmark
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
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.
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.
Time frame: 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.
Time frame: 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:
Time frame: 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
Time frame: 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
Time frame: 10 and 20 minutes (just before disposal) after the placement of the nicotine pouch in the oral cavity
Changes in Blood pressure (mmHg)
Time frame: 10 and 20 minutes (just before disposal) after the placement of the nicotine pouch in the oral cavity
Changes in Respiratory rate (breaths per minute)
Time frame: 10 and 20 minutes (just before disposal) after the placement of the nicotine pouch in the oral cavity
Changes in Oxygen saturation (percentage/%)
Time frame: 10 and 20 minutes (just before disposal) after the placement of the nicotine pouch in the oral cavity
Changes in Body temperature (degree Celsius)
Time frame: 10 and 20 minutes (just before disposal) after the placement of the nicotine pouch in the oral cavity
Subjective symptoms self-reported by the participants during the intervention using VAS-questionnaire of 10 known nicotine effect/symptoms (nausea, dizziness, lightheadedness, nervousness, sweatiness, headache, excessive salivation, heart pounding, confusion, and weakness).
Ekim Seven
Other
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
Acronym: NICOTUNE
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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