Effect of Nicotine Pouches on The Underlying Normal Electrocardiogram

NCT07057440 | Completed

• 1 other identifier: H-25018523
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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 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.

Conditions

Heart Rate; ECG; Vital Sign Monitoring; Symptoms

Outcome Measures

Primary Outcomes (1)

• Heart rate

  Changes in HR (beats/minute) obtained from an ECG recorded 20 minutes after nicotine pouch administration compared to the baseline ECG.

  10 and 20 minutes (just before disposal) after the placement of the nicotine pouch in the oral cavity

Secondary Outcomes (3)

• ECG parameters

  10 and 20 minutes (just before disposal) after the placement of the nicotine pouch in the oral cavity

• ST-T segment changes

  10 and 20 minutes (just before disposal) after the placement of the nicotine pouch in the oral cavity

• Arrhythmias

  10 and 20 minutes (just before disposal) after the placement of the nicotine pouch in the oral cavity

Other Outcomes (5)

• Blood pressure

  10 and 20 minutes (just before disposal) after the placement of the nicotine pouch in the oral cavity

• Respiratory rate

  10 and 20 minutes (just before disposal) after the placement of the nicotine pouch in the oral cavity

• Oxygen saturation

  10 and 20 minutes (just before disposal) after the placement of the nicotine pouch in the oral cavity

Study Arms (3)

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

Interventions

High-dose Nicotine Pouch OTHER

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.

High-dosage nicotine pouch arm

Low Dose Nicotine Pouch OTHER

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.

Low-dosage nicotine pouch arm

Placebo Pouch OTHER

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.

Placebo pouch arm

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ekim Seven: lead

Study Sites (1)

Department of cardiology, Copenhagen University Hospital, Amager & Hvidovre

Hvidovre, 2650, Denmark

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Cardiologist, PhD, clinical associate professor, department of cardiology, Hvidovre University Hospital

Study Record Dates

• First Submitted: June 10, 2025
• First Posted: July 9, 2025
• Study Start: June 27, 2025
• Primary Completion: October 31, 2025
• Study Completion: October 31, 2025
• Last Updated: December 11, 2025

Record last verified: 2025-12

Locations

DK (1)