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Acute Oral Effects of Heated Tobacco Products

NCT ID: NCT05538702

Last Updated: 2023-11-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-10-01

Study Completion Date

2023-11-22

Brief Summary

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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

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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

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Nicotine Dependence, Cigarettes

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Heated tobacco product with bland taste unit

Nicotine content: 0,5 mg

Group Type EXPERIMENTAL

IQOS 3.0 DOU with bland taste unit (Heated Tobacco Product)

Intervention Type DEVICE

Heated tobacco products (HTP) are devices which heat but do not burn tobacco. They do not produce cigarette smoke but rather an aerosol.

Heated tobacco product with menthol taste unit

Nicotine content: 0,5 mg

Group Type EXPERIMENTAL

IQOS 3.0 DUO with menthol taste unit (Heated Tobacco Product)

Intervention Type DEVICE

Heated tobacco products (HTP) are devices which heat but do not burn tobacco. They do not produce cigarette smoke but rather an aerosol.

Conventional cigarette

Nicotine content: 0,5 mg

Group Type EXPERIMENTAL

Marlboro Gold (Conventional cigarette)

Intervention Type DEVICE

Conventional cigarette

Heated tobacco product turned off with a bland taste unit

Placebo device

Group Type PLACEBO_COMPARATOR

IQOS 3.0 DUO turned off with a bland taste unit

Intervention Type DEVICE

Placebo device

Interventions

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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.

Intervention Type 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.

Intervention Type DEVICE

Marlboro Gold (Conventional cigarette)

Conventional cigarette

Intervention Type DEVICE

IQOS 3.0 DUO turned off with a bland taste unit

Placebo device

Intervention Type DEVICE

Other Intervention Names

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IQOS 3.0 DUO HEETS Bronze Selection IQOS 3.0 DUO HEETS Blue Selection Marlboro Gold 0,5 mg IQOS 3.0 DUO HEETS Bronze Selection

Eligibility Criteria

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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)
Minimum Eligible Age

18 Years

Maximum Eligible Age

49 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Semmelweis University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Semmelweis University, Department of Prosthodontics

Budapest, , Hungary

Site Status

Countries

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Hungary

Other Identifiers

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91-3/2015

Identifier Type: -

Identifier Source: org_study_id