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Acute Oral Effects of Heated Tobacco Products

Sponsor
Semmelweis University (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT05538702
Collaborator
(none)
15
Enrollment
1
Location
4
Arms
20
Anticipated Duration (Months)
0.8
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • 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
 N/A

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

Study Type:
Interventional
Anticipated Enrollment :
15 participants
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Basic Science
Official Title:
Acute Oral Effects of Heated Tobacco Products Compared to Traditional Cigarettes
Actual Study Start Date :
Oct 1, 2021
Anticipated Primary Completion Date :
May 1, 2023
Anticipated Study Completion Date :
Jun 1, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: Heated tobacco product with bland taste unit

Nicotine content: 0,5 mg

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.
Other Names:
  • IQOS 3.0 DUO
  • HEETS Bronze Selection

    		•
    Experimental: Heated tobacco product with menthol taste unit

    Nicotine content: 0,5 mg

    Device: 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.
    Other Names:
  • IQOS 3.0 DUO
  • HEETS Blue Selection

    		•
    Experimental: Conventional cigarette

    Nicotine content: 0,5 mg

    Device: Marlboro Gold (Conventional cigarette)
    Conventional cigarette
    Other Names:
  • Marlboro Gold 0,5 mg

    		•
    Placebo Comparator: Heated tobacco product turned off with a bland taste unit

    Placebo device

    Device: IQOS 3.0 DUO turned off with a bland taste unit
    Placebo device
    Other Names:
  • IQOS 3.0 DUO
  • HEETS Bronze Selection

    		•

    Outcome Measures

    Primary Outcome Measures

    1. 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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 49 Years
    Sexes Eligible for Study:
    All
    Accepts 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)

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Semmelweis University, Department of Prosthodontics Budapest Hungary 1088

    Sponsors and Collaborators

    • Semmelweis University

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Semmelweis University
    ClinicalTrials.gov Identifier:
    NCT05538702
    Other Study ID Numbers:
    • 91-3/2015
    First Posted:
    Sep 14, 2022
    Last Update Posted:
    Sep 14, 2022
    Last Verified:
    Jul 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Semmelweis University
    nicotine
    heated tobacco product
    blood flow
    cigarette
    Additional relevant MeSH terms:
    Tobacco Use Disorder
    Menthol

    Study Results

    No Results Posted as of Sep 14, 2022