Acute Cardiovascular and Electrocardiographic Effects of Nicotine Pouches: A study protocle for a Randomized, Double-Blind, Placebo-Controlled Crossover Trial (NICOTUNE STUDY)
- 1Department of Cardiology, Amager & Hvidovre Hospital, Copenhagen University Hospital, Denmark
Abstract
IntroductionNicotine Pouches are increasingly used as a smokeless alternative to cigarettes and other nicotine products, yet their acute cardiovascular effects remain poorly documented. While nicotines impact on heart rate and electrocardiogram (ECG) parameters is well-documented in smoking, no trials have evaluated these effects specifically for nicotine pouches.
MethodsThis 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.
ConclusionsThis 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 registrationThe 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).
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BibTeX
@misc{babaroudi2026acute,
title = {{Acute Cardiovascular and Electrocardiographic Effects of Nicotine Pouches: A study protocle for a Randomized, Double-Blind, Placebo-Controlled Crossover Trial (NICOTUNE STUDY)}},
author = {E. Khodi Babaroudi and M. H. X. Pham and I. T. Lenz and e. l. r. melgaard and J. Grand and J. D. Hove and E. Seven},
howpublished = {medRxiv},
year = {2026},
month = aug,
doi = {10.64898/2026.08.29.26361726},
url = {https://www.medrxiv.org/content/10.64898/2026.08.29.26361726v1},
note = {CC BY},
}
RIS
TY - UNPB
TI - Acute Cardiovascular and Electrocardiographic Effects of Nicotine Pouches: A study protocle for a Randomized, Double-Blind, Placebo-Controlled Crossover Trial (NICOTUNE STUDY)
AU - E. Khodi Babaroudi
AU - M. H. X. Pham
AU - I. T. Lenz
AU - e. l. r. melgaard
AU - J. Grand
AU - J. D. Hove
AU - E. Seven
PY - 2026
DA - 2026/08/29
PB - medRxiv
DO - 10.64898/2026.08.29.26361726
UR - https://www.medrxiv.org/content/10.64898/2026.08.29.26361726v1
AB - IntroductionNicotine Pouches are increasingly used as a smokeless alternative to cigarettes and other nicotine products, yet their acute cardiovascular effects remain poorly documented. While nicotines impact on heart rate and electrocardiogram (ECG) parameters is well-documented in smoking, no trials have evaluated these effects specifically for nicotine pouches. MethodsThis 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. ConclusionsThis 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 registrationThe 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).
ER -