NCT05538702

Acute Oral Effects of Heated Tobacco Products

Acute Oral Effects of Heated Tobacco Products Compared to Traditional Cigarettes

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 10 (actual)
• Sponsor: Semmelweis University · Academic / Other
• Sex: All
• Age: 18 Years – 49 Years
• Healthy volunteers: Accepted

Summary

Heated tobacco products (HTP) are devices which heat, but not burn tobacco. They do not produce cigarette smoke but rather an aerosol. HTPs are marketed as less harmful alternatives to smoking. Use and awareness of these devices have grown exponentially in recent years, with probably millions of people currently using them. There is very little literature about them, so it is quite important to study the effects caused on the human body by these products. The benefits and risks of HTP use are uncertain. There is no research on the acute oral effects of HTPs in the scientific literature.

Detailed description

Measurements of acute oral effects before and after using HTP with bland flavour (HEETS Bronze Selection), with methol flavour (HEETS Blue Selection), conventional cigarette and placebo device: measurement of exhaled CO changes by Smokerlyzer piCO measurement of oral mucosal blood flow changes by Perilam PSI System High Resolution (LASCA method) measurement of blood pressure and pulse by an automatic blood pressure monitor (Omron M2, Omron Healthcare Inc., Kyoto, Japan)

Conditions

• Nicotine Dependence, Cigarettes

Interventions

Type	Name	Description
DEVICE	IQOS 3.0 DOU with bland taste unit (Heated Tobacco Product)	Heated tobacco products (HTP) are devices which heat but do not burn tobacco. They do not produce cigarette smoke but rather an aerosol.
DEVICE	IQOS 3.0 DUO with menthol taste unit (Heated Tobacco Product)	Heated tobacco products (HTP) are devices which heat but do not burn tobacco. They do not produce cigarette smoke but rather an aerosol.
DEVICE	Marlboro Gold (Conventional cigarette)	Conventional cigarette
DEVICE	IQOS 3.0 DUO turned off with a bland taste unit	Placebo device

Timeline

• Start date: 2021-10-01
• Primary completion: 2023-11-22
• Completion: 2023-11-22
• First posted: 2022-09-14
• Last updated: 2023-11-27

Locations

1 site across 1 country: Hungary