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Nicotine pouches under the microscope: do they harm your heart?

NCT ID NCT07057440

Knowledge-focused Sponsor: Ekim Seven Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study looked at how nicotine pouches affect heart rate and heart electrical activity (ECG) in 20 adults who already use nicotine. Participants used high-dose, low-dose, or placebo pouches for 20 minutes. The goal was to see if nicotine pouches cause changes that could mean higher health risks.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Nicotine pouches (high dose, low dose, and placebo)
What this could lead to
If successful, this study could clarify whether nicotine pouches pose heart risks, informing safer use guidelines.
What could go wrong
This is a small, completed study with only 20 participants, so results may not apply broadly. It measures short-term effects only.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

20 people

The number who actually took part.

Started

Jun 2025

Finished

Oct 2025

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 70 years

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

ECG Heart rate Symptoms Vital sign monitoring

Contacts and locations

Locations

  • Department of cardiology, Copenhagen University Hospital, Amager & Hvidovre

    Hvidovre, 2650, Denmark

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