Acute Oral Effects of Heated Tobacco Products
1 other identifier
interventional
10
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Oct 2021
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2021
CompletedFirst Submitted
Initial submission to the registry
September 9, 2022
CompletedFirst Posted
Study publicly available on registry
September 14, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 22, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
November 22, 2023
CompletedNovember 27, 2023
November 1, 2023
2.1 years
September 9, 2022
November 23, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
baseline, immediately after smoking, and 15 minutes after smoking
Study Arms (4)
Heated tobacco product with bland taste unit
EXPERIMENTALNicotine content: 0,5 mg
Heated tobacco product with menthol taste unit
EXPERIMENTALNicotine content: 0,5 mg
Conventional cigarette
EXPERIMENTALNicotine content: 0,5 mg
Heated tobacco product turned off with a bland taste unit
PLACEBO COMPARATORPlacebo device
Interventions
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 products (HTP) are devices which heat but do not burn tobacco. They do not produce cigarette smoke but rather an aerosol.
Conventional cigarette
Placebo device
Eligibility Criteria
You may qualify if:
- age: 18-49 years
- signed consent form
- smoking regularly heated tobacco product and/or conventional cigarette for \> half year
You may not qualify if:
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Semmelweis University, Department of Prosthodontics
Budapest, 1088, Hungary
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- BASIC SCIENCE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 9, 2022
First Posted
September 14, 2022
Study Start
October 1, 2021
Primary Completion
November 22, 2023
Study Completion
November 22, 2023
Last Updated
November 27, 2023
Record last verified: 2023-11