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OpenTrials
Completed

NCT Number: NCT07057440

Effect of Nicotine Pouches on The Underlying Normal Electrocardiogram

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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Key information

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of cardiology, Copenhagen University Hospital, Amager & Hvidovre

Hvidovre, 2650, Denmark

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

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.

Primary outcomes

  1. Heart rate

    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.

Secondary outcomes

  1. ECG parameters

    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:

    • PR interval (msec)
    • QRS duration (msec)
    • QT interval (corrected, QTc) (msec)
    • HRV (msec)
  2. ST-T segment changes

    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

  3. Arrhythmias

    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

Other outcomes

  1. Blood pressure

    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)

  2. Respiratory rate

    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)

  3. Oxygen saturation

    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/%)

  4. Body temperature

    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)

  5. Self-reported symptoms

    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).

Sponsors and collaborators

Lead sponsor

Ekim Seven

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Jul 9, 2025
Registry last updated
Dec 11, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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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