Acute Oral Effects of Heated Tobacco Products

November 23, 2023 updated by: Semmelweis University

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

10

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Hungary
      • Budapest, Hungary, 1088
        • Semmelweis University, Department of Prosthodontics

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years to 45 years (Adult)

Accepts Healthy Volunteers

Yes

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
baseline, immediately after smoking, and 15 minutes after smoking

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Semmelweis University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 1, 2021

Primary Completion (Actual)

November 22, 2023

Study Completion (Actual)

November 22, 2023

Study Registration Dates

First Submitted

September 9, 2022

First Submitted That Met QC Criteria

September 9, 2022

First Posted (Actual)

September 14, 2022

Study Record Updates

Last Update Posted (Actual)

November 27, 2023

Last Update Submitted That Met QC Criteria

November 23, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 91-3/2015

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Nicotine Dependence, Cigarettes

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Peru

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe