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Acute Oral Effects of Heated Tobacco Products

Primary Purpose

Nicotine Dependence, Cigarettes

Status
Active
Phase
Not Applicable
Locations
Hungary
Study Type
Interventional
Intervention
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
Sponsored by
Semmelweis University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Nicotine Dependence, Cigarettes focused on measuring nicotine, heated tobacco product, blood flow, cigarette

Eligibility Criteria

18 Years - 49 Years (Adult)All SexesAccepts Healthy Volunteers

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)

Sites / Locations

  • Semmelweis University, Department of Prosthodontics

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Placebo Comparator

Arm Label

Heated tobacco product with bland taste unit

Heated tobacco product with menthol taste unit

Conventional cigarette

Heated tobacco product turned off with a bland taste unit

Arm Description

Nicotine content: 0,5 mg

Nicotine content: 0,5 mg

Nicotine content: 0,5 mg

Placebo device

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
September 9, 2022
Last Updated
September 9, 2022
Sponsor
Semmelweis University
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1. Study Identification

Unique Protocol Identification Number
NCT05538702
Brief Title
Acute Oral Effects of Heated Tobacco Products
Official Title
Acute Oral Effects of Heated Tobacco Products Compared to Traditional Cigarettes
Study Type
Interventional

2. Study Status

Record Verification Date
July 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
October 1, 2021 (Actual)
Primary Completion Date
May 2023 (Anticipated)
Study Completion Date
June 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Semmelweis University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.
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)

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Nicotine Dependence, Cigarettes
Keywords
nicotine, heated tobacco product, blood flow, cigarette

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
15 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Heated tobacco product with bland taste unit
Arm Type
Experimental
Arm Description
Nicotine content: 0,5 mg
Arm Title
Heated tobacco product with menthol taste unit
Arm Type
Experimental
Arm Description
Nicotine content: 0,5 mg
Arm Title
Conventional cigarette
Arm Type
Experimental
Arm Description
Nicotine content: 0,5 mg
Arm Title
Heated tobacco product turned off with a bland taste unit
Arm Type
Placebo Comparator
Arm Description
Placebo device
Intervention Type
Device
Intervention Name(s)
IQOS 3.0 DOU with bland taste unit (Heated Tobacco Product)
Other Intervention Name(s)
IQOS 3.0 DUO, HEETS Bronze Selection
Intervention Description
Heated tobacco products (HTP) are devices which heat but do not burn tobacco. They do not produce cigarette smoke but rather an aerosol.
Intervention Type
Device
Intervention Name(s)
IQOS 3.0 DUO with menthol taste unit (Heated Tobacco Product)
Other Intervention Name(s)
IQOS 3.0 DUO, HEETS Blue Selection
Intervention Description
Heated tobacco products (HTP) are devices which heat but do not burn tobacco. They do not produce cigarette smoke but rather an aerosol.
Intervention Type
Device
Intervention Name(s)
Marlboro Gold (Conventional cigarette)
Other Intervention Name(s)
Marlboro Gold 0,5 mg
Intervention Description
Conventional cigarette
Intervention Type
Device
Intervention Name(s)
IQOS 3.0 DUO turned off with a bland taste unit
Other Intervention Name(s)
IQOS 3.0 DUO, HEETS Bronze Selection
Intervention Description
Placebo device
Primary Outcome Measure Information:
Title
Change from baseline in blood flow after smoking
Description
The blood flow changes are measured by Laser Speckle Contrast Analyzer (LASCA) before (baseline), immediately after, and 15 minutes after smoking.
Time Frame
baseline, immediately after smoking, and 15 minutes after smoking

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
49 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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)
Facility Information:
Facility Name
Semmelweis University, Department of Prosthodontics
City
Budapest
ZIP/Postal Code
1088
Country
Hungary

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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Acute Oral Effects of Heated Tobacco Products

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