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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo pouch arm | Placebo Comparator |
| |
| Low-dosage nicotine pouch arm | Experimental |
| |
| High-dosage nicotine pouch arm | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| High-dose Nicotine Pouch | Other | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Heart rate | Changes in HR (beats/minute) obtained from an ECG recorded 20 minutes after nicotine pouch administration compared to the baseline ECG. | 10 and 20 minutes (just before disposal) after the placement of the nicotine pouch in the oral cavity |
| Measure | Description | Time Frame |
|---|---|---|
| ECG parameters | Changes in various ECG parameters from baseline: • PR interval (msec) • QRS duration (msec) • QT interval (corrected, QTc) (msec) • HRV (msec) | 10 and 20 minutes (just before disposal) after the placement of the nicotine pouch in the oral cavity |
| ST-T segment changes |
| Measure | Description | Time Frame |
|---|---|---|
| Blood pressure | Changes in Blood pressure (mmHg) | 10 and 20 minutes (just before disposal) after the placement of the nicotine pouch in the oral cavity |
| Respiratory rate | Changes in Respiratory rate (breaths per minute) |
Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of cardiology, Copenhagen University Hospital, Amager & Hvidovre | Hvidovre | 2650 | Denmark |
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| Low Dose Nicotine Pouch | Other | 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 | Other | 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. |
|
ST-T segment changes, e.g., depression/elevation/inversion (mm) from baseline |
| 10 and 20 minutes (just before disposal) after the placement of the nicotine pouch in the oral cavity |
| Arrhythmias | Any arrhythmias e.g., ectopic beats (yes/no, numerical) detected on the ECG compared with baseline ECG | 10 and 20 minutes (just before disposal) after the placement of the nicotine pouch in the oral cavity |
| 10 and 20 minutes (just before disposal) after the placement of the nicotine pouch in the oral cavity |
| Oxygen saturation | Changes in Oxygen saturation (percentage/%) | 10 and 20 minutes (just before disposal) after the placement of the nicotine pouch in the oral cavity |
| Body temperature | Changes in Body temperature (degree Celsius) | 10 and 20 minutes (just before disposal) after the placement of the nicotine pouch in the oral cavity |
| Self-reported symptoms | 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). | 10 and 20 minutes (just before disposal) after the placement of the nicotine pouch in the oral cavity |