Acute Oral Effects of Heated Tobacco Products

Nicotine Dependence, Cigarettes Clinical Trial

Official title:

Acute Oral Effects of Heated Tobacco Products Compared to Traditional Cigarettes

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05538702
• Other study ID #: 91-3/2015
• Status: Completed
• Phase: N/A
• Start date: October 1, 2021
• Est. completion date: November 22, 2023

Study information

• Verified date: November 2023
• Source: Semmelweis University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: November 22, 2023
• Est. primary completion date: November 22, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 49 Years

Eligibility

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)

Related Conditions & MeSH terms

• Nicotine Dependence, Cigarettes
• Tobacco Use Disorder

Intervention

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.
• 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.
• Marlboro Gold (Conventional cigarette)
Conventional cigarette
• IQOS 3.0 DUO turned off with a bland taste unit
Placebo device

Locations

Country	Name	City	State
Hungary	Semmelweis University, Department of Prosthodontics	Budapest

Sponsors (1)

Lead Sponsor	Collaborator
Semmelweis University

Country where clinical trial is conducted

Hungary, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline in blood flow after smoking	The blood flow changes are measured by Laser Speckle Contrast Analyzer (LASCA) before (baseline), immediately after, and 15 minutes after smoking.	baseline, immediately after smoking, and 15 minutes after smoking