Acute Oral Effects of Heated Tobacco Products

Not Applicable

Completed

• Conditions: Nicotine Dependence, Cigarettes
• Interventions: 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); Device: IQOS 3.0 DOU with bland taste unit (Heated Tobacco Product)

• Registration Number: NCT05538702
• Lead Sponsor: Semmelweis University

Brief 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)

Study Timeline

• Study Start: 2021-10-01
• Study First Submitted: 2022-09-09
• Study First Submitted QC: 2022-09-09
• Study First Posted: 2022-09-14
• Status Verified: 2023-11
• Primary Completion: 2023-11-22
• Study Completion: 2023-11-22
• Last Update Submitted: 2023-11-23
• Last Update Posted: 2023-11-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 10

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Heated tobacco product with menthol taste unit	IQOS 3.0 DUO with menthol taste unit (Heated Tobacco Product)	Nicotine content: 0,5 mg
Heated tobacco product turned off with a bland taste unit	IQOS 3.0 DUO turned off with a bland taste unit	Placebo device
Conventional cigarette	Marlboro Gold (Conventional cigarette)	Nicotine content: 0,5 mg
Heated tobacco product with bland taste unit	IQOS 3.0 DOU with bland taste unit (Heated Tobacco Product)	Nicotine content: 0,5 mg

Primary Outcome Measures

Name	Time	Method
Change from baseline in blood flow after smoking	baseline, immediately after smoking, and 15 minutes after smoking	The blood flow changes are measured by Laser Speckle Contrast Analyzer (LASCA) before (baseline), immediately after, and 15 minutes after smoking.

Trial Locations

Locations (1)

Semmelweis University, Department of Prosthodontics; 🇭🇺 Budapest, Hungary