Acute Oral Effects of Heated Tobacco Products

Semmelweis University

Status: Completed

Conditions: Nicotine Dependence, Cigarettes

Treatments: Device: IQOS 3.0 DOU with bland taste unit (Heated Tobacco Product); Device: IQOS 3.0 DUO with menthol taste unit (Heated Tobacco Product); Device: IQOS 3.0 DUO turned off with a bland taste unit; Device: Marlboro Gold (Conventional cigarette)

Study type: Interventional

Funder types: Other

Identifiers

NCT05538702

91-3/2015

Details and patient eligibility

About

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.

Full 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)

Enrollment: 10 patients

Sex: All

Ages: 18 to 49 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• age: 18-49 years
• signed consent form
• smoking regularly heated tobacco product and/or conventional cigarette for > half year

Exclusion criteria

• not pregnant and not planning pregnancy in the next 6 month BMI index < 30
• no severe parodontal disease
• no acute illness in the last 2 weeks
• no chronic disease (eg.: diabetes)

Trial design

Primary purpose: Basic Science

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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10 participants in 4 patient groups, including a placebo group

Heated tobacco product with bland taste unit

Experimental group

Description:

Nicotine content: 0,5 mg

Treatment:

Device: IQOS 3.0 DOU with bland taste unit (Heated Tobacco Product)

Heated tobacco product with menthol taste unit

Experimental group

Description:

Nicotine content: 0,5 mg

Treatment:

Device: IQOS 3.0 DUO with menthol taste unit (Heated Tobacco Product)

Conventional cigarette

Experimental group

Description:

Nicotine content: 0,5 mg

Treatment:

Device: Marlboro Gold (Conventional cigarette)

Heated tobacco product turned off with a bland taste unit

Placebo Comparator group

Description:

Placebo device

Treatment:

Device: IQOS 3.0 DUO turned off with a bland taste unit