Effect of Nicotine Pouches on The Underlying Normal Electrocardiogram

Launched by EKIM SEVEN · Jul 4, 2025

Keywords

ClinConnect Summary

The NICOTUNE study is examining how nicotine pouches affect the heart and related body signals in healthy adults. In a randomized, quadruple-blind, cross-over design, about 20 adults aged 18–70 who use nicotine will try three pouch types in random order: a placebo (no nicotine), a low-dose nicotine pouch, and a high-dose nicotine pouch. Each session involves placing the pouch in the mouth for about 20 minutes, after which researchers measure heart rate and other heart- and body-signs (like blood pressure, breathing rate, oxygen levels, and temperature) and collect a short questionnaire about nicotine effects.

To be eligible, you would need to be 18–70 years old, without a history of heart disease or medicines that affect heart function, not pregnant, and in good health at the start of the study. Regular or occasional nicotine users are allowed, but you must avoid nicotine, caffeine, and alcohol for at least 6 hours before sessions. The study is being done at Hvidovre University Hospital in Denmark and is currently enrolling by invitation, with an estimated completion around December 2025. The goal is to see whether nicotine pouches cause meaningful changes in heart rate, ECG readings, and other vital signs to understand potential health risks.

Gender

ALL

Eligibility criteria

• 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.