Effect of Nicotine Pouches on The Underlying Normal Electrocardiogram (NICOTUNE)

Ekim Seven

Status

Invitation-only

Conditions

ECG

Symptoms

Vital Sign Monitoring

Heart Rate

Treatments

Other: High-dose Nicotine Pouch

Other: Placebo Pouch

Other: Low Dose Nicotine Pouch

Study type

Interventional

Funder types

Other

Identifiers

NCT07057440

H-25018523

Details and patient eligibility

About

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.

Enrollment

20 estimated patients

Sex

All

Ages

18 to 70 years old

Volunteers

Accepts Healthy Volunteers

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.