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OpenTrials
Completed

NCT Number: NCT05538702

Acute Oral Effects of Heated Tobacco Products

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.

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Key information

Conditions

Nicotine Dependence, Cigarettes Chemically-Induced Disorders Mental Disorders Substance-Related Disorders Tobacco Use Disorder

Age range

18 year–49 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Semmelweis University, Department of Prosthodontics

Budapest, 1088, Hungary

About this study

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)

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

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

Device

Heated tobacco products (HTP) are devices which heat but do not burn tobacco. They do not produce cigarette smoke but rather an aerosol.

Other names: IQOS 3.0 DUO, HEETS Bronze Selection

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

Device

Heated tobacco products (HTP) are devices which heat but do not burn tobacco. They do not produce cigarette smoke but rather an aerosol.

Other names: IQOS 3.0 DUO, HEETS Blue Selection

Marlboro Gold (Conventional cigarette)

Device

Conventional cigarette

Other names: Marlboro Gold 0,5 mg

IQOS 3.0 DUO turned off with a bland taste unit

Device

Placebo device

Other names: IQOS 3.0 DUO, HEETS Bronze Selection

Primary outcomes

  1. Change from baseline in blood flow after smoking

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Semmelweis University

Other

Registry information

Official study title

Acute Oral Effects of Heated Tobacco Products Compared to Traditional Cigarettes

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Sep 14, 2022
Registry last updated
Nov 27, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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