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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05538702
Other study ID # 91-3/2015
Secondary ID
Status Completed
Phase N/A
First received
Last updated
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
Health authority
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)

Study Design


Related Conditions & MeSH terms


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
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