Nicotine Dependence, CigarettesNCT05538702
Acute Oral Effects of Heated Tobacco Products
A study testing IQOS 3.0 DOU with bland taste unit (Heated Tobacco Product), IQOS 3.0 DUO with menthol taste unit (Heated Tobacco Product) and Marlboro Gold (Conventional cigarette) in people with Nicotine Dependence, Cigarettes, run by Semmelweis University at 1 site in Hungary.
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. Read more about this study
- Who is it for?
- Ages 18 to 49 yearsHealthy volunteers can take part
- Conditions the study is for
- Nicotine Dependence, Cigarettes
- What is being tested?
- IQOS 3.0 DOU with bland taste unit (Heated Tobacco Product), IQOS 3.0 DUO with menthol taste unit (Heated Tobacco Product) and Marlboro Gold (Conventional cigarette)
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 10 participants
- Where
- 1 siteHungary
- Study dates
- 1 Oct 2021to 22 Nov 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 49 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- age: 18-49 years
- signed consent form
- smoking regularly heated tobacco product and/or conventional cigarette for > half year
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
Hungary1 site
Semmelweis University, Department of Prosthodontics
Budapest, 1088
About this study
Official title: Acute Oral Effects of Heated Tobacco Products Compared to Traditional Cigarettes
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.
Read the 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)
- Conditions
- Nicotine Dependence, Cigarettes
- Being 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
- Keywords
- nicotine, heated tobacco product, blood flow, cigarette
- Medical subject headings
- Tobacco Use Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IQOS 3.0 DOU with bland taste unit (Heated Tobacco Product)Device
Also called IQOS 3.0 DUO, HEETS Bronze Selection
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)Device
Also called IQOS 3.0 DUO, HEETS Blue Selection
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)Device
Also called Marlboro Gold 0,5 mg
Conventional cigarette
IQOS 3.0 DUO turned off with a bland taste unitDevice
Also called IQOS 3.0 DUO, HEETS Bronze Selection
Placebo device
| Study group | Role | What they receive |
|---|---|---|
| Heated tobacco product with bland taste unit | Experimental | Nicotine content: 0,5 mg Receives: Device: IQOS 3.0 DOU with bland taste unit (Heated Tobacco Product) |
| Heated tobacco product with menthol taste unit | Experimental | Nicotine content: 0,5 mg Receives: Device: IQOS 3.0 DUO with menthol taste unit (Heated Tobacco Product) |
| Conventional cigarette | Experimental | Nicotine content: 0,5 mg Receives: Device: Marlboro Gold (Conventional cigarette) |
| Heated tobacco product turned off with a bland taste unit | Placebo comparator | Placebo device Receives: Device: IQOS 3.0 DUO turned off with a bland taste unit |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: baseline, immediately after smoking, and 15 minutes after smoking
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2022
- Study start1 Oct 2021
- Primary completion22 Nov 2023
- Study completion22 Nov 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Nicotine Dependence, CigarettesStudies of the same condition, open and under way.
- More trials run by Semmelweis UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Semmelweis University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05538702
- Sponsor's protocol ID
- 91-3/2015
- Status last verified
- Nov 2023
- First submitted
- 9 Sep 2022
- Last updated
- 27 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Kulcsar N, Mikecs B, Kelemen K, Dinya E, Vag J, Hermann P, Vamos O, Kispelyi B. Acute effects of traditional and heated tobacco products on palatal blood flow and cardiac function in smokers: A crossover pilot study. Exp Clin Psychopharmacol. 2026 Apr;34(2):125-132. doi: 10.1037/pha0000828.
PubMed 41989443
Study at a glance
From the registry record, last updated by the sponsor on 27 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acute Oral Effects of Heated Tobacco Products Compared to Traditional Cigarettes
- ClinicalTrials.gov ID
- NCT05538702
- Acronym / sponsor ID
- 91-3/2015
- Conditions
- Nicotine Dependence, Cigarettes
- Keywords
- nicotine, heated tobacco product, blood flow, cigarette
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Semmelweis UniversityUniversity, hospital or other
- Study start
- 1 Oct 2021 (actual)
- Primary completion
- 22 Nov 2023 (actual)
- Study completion
- 22 Nov 2023 (actual)
- First posted
- 14 Sep 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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)
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Heated tobacco product with bland taste unit | Experimental | Device: IQOS 3.0 DOU with bland taste unit (Heated Tobacco Product)Nicotine content: 0,5 mg |
| Heated tobacco product with menthol taste unit | Experimental | Device: IQOS 3.0 DUO with menthol taste unit (Heated Tobacco Product)Nicotine content: 0,5 mg |
| Conventional cigarette | Experimental | Device: Marlboro Gold (Conventional cigarette)Nicotine content: 0,5 mg |
| Heated tobacco product turned off with a bland taste unit | Placebo comparator | Device: IQOS 3.0 DUO turned off with a bland taste unitPlacebo device |
Who may qualify
- Ages
- 18 to 49 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- age: 18-49 years
- signed consent form
- smoking regularly heated tobacco product and/or conventional cigarette for > half year
Key exclusion criteria (4 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| IQOS 3.0 DOU with bland taste unit (Heated Tobacco Product)Also: IQOS 3.0 DUO, HEETS Bronze SelectionHeated tobacco products (HTP) are devices which heat but do not burn tobacco. They do not produce cigarette smoke but rather an aerosol. | Device | Heated tobacco product with bland taste unit |
| IQOS 3.0 DUO with menthol taste unit (Heated Tobacco Product)Also: IQOS 3.0 DUO, HEETS Blue SelectionHeated tobacco products (HTP) are devices which heat but do not burn tobacco. They do not produce cigarette smoke but rather an aerosol. | Device | Heated tobacco product with menthol taste unit |
| Marlboro Gold (Conventional cigarette)Also: Marlboro Gold 0,5 mgConventional cigarette | Device | Conventional cigarette |
| IQOS 3.0 DUO turned off with a bland taste unitAlso: IQOS 3.0 DUO, HEETS Bronze SelectionPlacebo device | Device | Heated tobacco product turned off with a bland taste unit |
Primary outcome
Change from baseline in blood flow after smoking
Time frame: 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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Nov 2023.
- Derived from this study: PubMed 41989443Kulcsar N, Mikecs B, Kelemen K, Dinya E, Vag J, Hermann P, Vamos O, Kispelyi B. Acute effects of traditional and heated tobacco products on palatal blood flow and cardiac function in smokers: A crossover pilot study. Exp Clin Psychopharmacol. 2026 Apr;34(2):125-132. doi: 10.1037/pha0000828.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing IQOS 3.0 DOU with bland taste unit (Heated Tobacco Product), IQOS 3.0 DUO with menthol taste unit (Heated Tobacco Product) and Marlboro Gold (Conventional cigarette) in people with Nicotine Dependence, Cigarettes, run by Semmelweis University at 1 site in Hungary.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Hungary. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline in blood flow after smoking (time frame: baseline, immediately after smoking, and 15 minutes after smoking). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05538702, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Nov 2023.