Ignite Creation Date:
2025-12-25 @ 3:49 AM
Ignite Modification Date:
2026-02-12 @ 5:27 AM
Study NCT ID:
NCT05538702
Status:
COMPLETED
Last Update Posted:
2023-11-27
First Post:
2022-09-09
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Acute Oral Effects of Heated Tobacco Products
Sponsor:
Semmelweis University
Organization:
Study Overview
Official Title:
Acute Oral Effects of Heated Tobacco Products Compared to Traditional Cigarettes
Status:
COMPLETED
Status Verified Date:
2023-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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)
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: