Acute Oral Effects of Heated Tobacco Products
Key facts
- Who runs it
- Semmelweis University
- Where
- Hungary1 site in 1 countryChoose a country to see its sites
- Trial code
- Status
- Completed
- People taking part
- 10 people enrolled
- Started
- 1 Oct 2021
- Ended
- 22 Nov 2023
- Type of study
- Interventional, 4 groupsOne group gets a placebo (a dummy treatment), for comparison.
- Treatments tested
- IQOS 3.0 DOU with bland taste unit (Heated Tobacco Product)
- IQOS 3.0 DUO with menthol taste unit (Heated Tobacco Product)
- Marlboro Gold (Conventional cigarette)
- IQOS 3.0 DUO turned off with a bland taste unit
- Record updated
- 27 November 2023
Who can take part
- Age
- 18 years to 49 years
- Sex
- Women and men
- Healthy volunteers
- Can take part
The registry criteria, word for word
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Who can take part
- age: 18-49 years
- signed consent form
- smoking regularly heated tobacco product and/or conventional cigarette for > half year
Who cannot take part
- no severe parodontal disease
- no acute illness in the last 2 weeks
- no chronic disease (eg.: diabetes)
- not pregnant and not planning pregnancy in the next 6 month BMI index < 30
This trial has no sites in United States.
It has sites in one country. Choose a country to see its sites.
About the trial
What the trial wants to find out
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.
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The benefits and risks of HTP use are uncertain. There is no research on the acute oral effects of HTPs in the scientific literature.
The 4 groups in the trial
- Heated tobacco product with bland taste unitTreatment being tested
Nicotine content: 0,5 mg
Treatment: IQOS 3.0 DOU with bland taste unit (Heated Tobacco Product)
- Heated tobacco product with menthol taste unitTreatment being tested
Nicotine content: 0,5 mg
Treatment: IQOS 3.0 DUO with menthol taste unit (Heated Tobacco Product)
- Conventional cigaretteTreatment being tested
Nicotine content: 0,5 mg
Treatment: Marlboro Gold (Conventional cigarette)
- Heated tobacco product turned off with a bland taste unitPlacebo, for comparison
Placebo device
Treatment: IQOS 3.0 DUO turned off with a bland taste unit
Data and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- Acute Oral Effects of Heated Tobacco Products Compared to Traditional Cigarettes
- Record updated
- 27 November 2023