Nicotine Dependence, Cigarettes
Conditions
Keywords
nicotine, heated tobacco product, blood flow, cigarette
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)
Interventions
DEVICEIQOS 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.
DEVICEIQOS 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.
Conventional cigarette
DEVICEIQOS 3.0 DUO turned off with a bland taste unit
Placebo device
Sponsors
Semmelweis University
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 49 Years
Healthy volunteers
Yes
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
Hungary
Outcome results
None listed