Acute Oral Effects of Heated Tobacco Products

Study Overview
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Brief Summary
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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
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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)

Official Title
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Acute Oral Effects of Heated Tobacco Products Compared to Traditional Cigarettes

Conditions
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Nicotine Dependence, Cigarettes

Intervention / Treatment
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* Device: IQOS 3.0 DOU with bland taste unit (Heated Tobacco Product)
* Device: IQOS 3.0 DUO with menthol taste unit (Heated Tobacco Product)
* Device: Marlboro Gold (Conventional cigarette)
* Device: IQOS 3.0 DUO turned off with a bland taste unit


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 49 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Heated tobacco product with bland taste unit<br>Nicotine content: 0,5 mg | Device: IQOS 3.0 DOU with bland taste unit (Heated Tobacco Product)<br>* Heated tobacco products (HTP) are devices which heat but do not burn tobacco. They do not produce cigarette smoke but rather an aerosol.<br>* Other names: HEETS Bronze Selection;|
| Experimental: Heated tobacco product with menthol taste unit<br>Nicotine content: 0,5 mg | Device: IQOS 3.0 DUO with menthol taste unit (Heated Tobacco Product)<br>* Heated tobacco products (HTP) are devices which heat but do not burn tobacco. They do not produce cigarette smoke but rather an aerosol.<br>* Other names: HEETS Blue Selection;|
| Experimental: Conventional cigarette<br>Nicotine content: 0,5 mg | Device: Marlboro Gold (Conventional cigarette)<br>* Conventional cigarette<br>* Other names: Marlboro Gold 0,5 mg;|
| Placebo Comparator: Heated tobacco product turned off with a bland taste unit<br>Placebo device | Device: IQOS 3.0 DUO turned off with a bland taste unit<br>* Placebo device<br>* Other names: HEETS Bronze Selection;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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nicotine, heated tobacco product, blood flow, cigarette