Acute Cardiovascular and Electrocardiographic Effects of Nicotine Pouches: A study protocol for a Randomized, Double-Blind, Placebo-Controlled Crossover Trial (NICOTUNE STUDY)
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Introduction
Nicotine Pouches are increasingly used as a smokeless alternative to cigarettes and other nicotine products, yet their acute cardiovascular effects remain poorly documented. While nicotine’s impact on heart rate and electrocardiogram (ECG) parameters is well-documented in smoking, no trials have evaluated these effects specifically for nicotine pouches.
Methods
This study is a single-center, double-blind, placebo-controlled, crossover trial which will include 20 healthy adult nicotine users. Participants will undergo three sessions, receiving either a placebo, 6 mg, or 14 mg nicotine pouch in random order. Heart rate obtained by an ECG and various other ECG parameters, vital signs, and subjective symptoms will be measured at baseline, and multiple time points over 30 minutes.
Conclusions
This study aims to determine whether nicotine pouches cause acute changes in heart rate, ECG parameters, vital signs, and self-reported symptoms. We hypothesize that higher nicotine pouch does will lead to measurable increases in heart rate and other autonomic effects compared to placebo.
Trial registration
The study has been approved by The Committees on Health Research Ethics in the Capital Region of Denmark (H-25018523). The study was registered with Clinicaltrial.org on 2025.07.09 (Identifier: NCT07057440 ).
