Heart RateNICOTUNENCT07057440
Effect of Nicotine Pouches on The Underlying Normal Electrocardiogram
A study testing High-dose Nicotine Pouch and Low Dose Nicotine Pouch in people with Heart Rate and ECG, run by Ekim Seven at 1 site in Denmark.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Heart Rate, ECG, Vital Sign Monitoring
- What is being tested?
- High-dose Nicotine Pouch and Low Dose Nicotine Pouch
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteDenmark
- Study dates
- 27 Jun 2025to 31 Oct 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Department of cardiology, Copenhagen University Hospital, Amager & Hvidovre
Hvidovre, 2650
About this study
Official 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
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.
Read more
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.
- Conditions
- Heart Rate, ECG, Vital Sign Monitoring, Symptoms
- Being tested
- High-dose Nicotine Pouch, Low Dose Nicotine Pouch, Placebo Pouch
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High-dose Nicotine PouchOther
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 PouchOther
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 PouchOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Placebo pouch arm | Placebo comparator | Not described Receives: Other: Placebo Pouch |
| Low-dosage nicotine pouch arm | Experimental | Not described Receives: Other: Low Dose Nicotine Pouch |
| High-dosage nicotine pouch arm | Experimental | Not described Receives: Other: High-dose Nicotine Pouch |
What is being measured
The primary outcome is the main question the study is designed to answer.
Heart rate
Changes in HR (beats/minute) obtained from an ECG recorded 20 minutes after nicotine pouch administration compared to the baseline ECG.
Measured: 10 and 20 minutes (just before disposal) after the placement of the nicotine pouch in the oral cavity
Secondary outcomes (3)
ECG parameters
Changes in various ECG parameters from baseline:
- PR interval (msec)
- QRS duration (msec)
- QT interval (corrected, QTc) (msec)
- HRV (msec)
Measured: 10 and 20 minutes (just before disposal) after the placement of the nicotine pouch in the oral cavity
ST-T segment changes
ST-T segment changes, e.g., depression/elevation/inversion (mm) from baseline
Measured: 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
Measured: 10 and 20 minutes (just before disposal) after the placement of the nicotine pouch in the oral cavity
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jul 2025
- Study start27 Jun 2025
- Primary completion31 Oct 2025
- Study completion31 Oct 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart RateStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ekim Seven
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Ekim Seven, Hvidovre University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07057440
- Sponsor's protocol ID
- H-25018523
- Acronym
- NICOTUNE
- Status last verified
- Dec 2025
- First submitted
- 10 Jun 2025
- Last updated
- 11 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 11 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT07057440
- Acronym / sponsor ID
- NICOTUNE / H-25018523
- Conditions
- Heart Rate, ECG, Vital Sign Monitoring, Symptoms
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Ekim SevenUniversity, hospital or other
- Study start
- 27 Jun 2025 (actual)
- Primary completion
- 31 Oct 2025 (actual)
- Study completion
- 31 Oct 2025 (actual)
- First posted
- 9 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Placebo pouch arm | Placebo comparator | Other: Placebo Pouch |
| Low-dosage nicotine pouch arm | Experimental | Other: Low Dose Nicotine Pouch |
| High-dosage nicotine pouch arm | Experimental | Other: High-dose Nicotine Pouch |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| High-dose Nicotine PouchA 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. | Other | High-dosage nicotine pouch arm |
| Low Dose Nicotine PouchA 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. | Other | Low-dosage nicotine pouch arm |
| Placebo PouchA 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. | Other | Placebo pouch arm |
Primary outcome
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.
3 secondary outcomes
ECG parameters
Time frame: 10 and 20 minutes (just before disposal) after the placement of the nicotine pouch in the oral cavity
ST-T segment changes
Time frame: 10 and 20 minutes (just before disposal) after the placement of the nicotine pouch in the oral cavity
Arrhythmias
Time frame: 10 and 20 minutes (just before disposal) after the placement of the nicotine pouch in the oral cavity
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Dec 2025.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing High-dose Nicotine Pouch and Low Dose Nicotine Pouch in people with Heart Rate and ECG, run by Ekim Seven at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Heart rate (time frame: 10 and 20 minutes (just before disposal) after the placement of the nicotine pouch in the oral cavity). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Dec 2025.