Ignite Creation Date:
2025-12-24 @ 11:38 PM
Ignite Modification Date:
2026-01-01 @ 12:06 PM
Study NCT ID:
NCT04013256
Status:
SUSPENDED
Last Update Posted:
2023-08-28
First Post:
2019-06-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Controlled Exposure of Healthy Nonsmokers to Secondhand and Thirdhand Cigarette Smoke
Sponsor:
University of California, San Francisco
Organization:
Study Overview
Official Title:
Controlled Human Exposure and THS Generation Core
Status:
SUSPENDED
Status Verified Date:
2023-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
The human exposure facility was closed by the University.
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
THS04
Brief Summary:
This study compares the health effects of dermal and inhalational exposure to thirdhand cigarette smoke to those of inhalational exposure to secondhand cigarette smoke in healthy, adult nonsmokers. Our hypothesis is that dermal exposure increases exposure to the tobacco specific carcinogen, NNK and may affect both endothelial function and epidermal integrity.
Detailed Description:
Thirdhand cigarette smoke is the smoke chemicals that persist in the environment after smoking. Indoors, they can be found both on surfaces and in the air. Thirdhand smoke derives from secondhand smoke and contains the chemicals that stick to surfaces, are re-emitted into the air and that form by chemical reactions both on surfaces and in the air.
Thirdhand smoke can contain higher concentrations of the tobacco-specific nitrosamine and known carcinogen 4-(methylnitrosamino)-1-(3-pyridyl)-1-butanone (NNK) than secondhand smoke, because nicotine reacts to form NNK in the indoor environment. Dermal exposure to thirdhand smoke includes nicotine, NNK and other tobacco-specific nitrosamines, polycyclic aromatic hydrocarbons, and volatile organic compounds. Inhalational exposure to thirdhand smoke includes nicotine, ultrafine particles and volatile organic compounds. Previous studies have shown that inhalational exposure to secondhand cigarette smoke causes endothelial dysfunction, which is a risk factor for heart disease and heart attacks.
Thirdhand smoke can contain higher concentrations of the tobacco-specific nitrosamine and known carcinogen 4-(methylnitrosamino)-1-(3-pyridyl)-1-butanone (NNK) than secondhand smoke, because nicotine reacts to form NNK in the indoor environment. Dermal exposure to thirdhand smoke includes nicotine, NNK and other tobacco-specific nitrosamines, polycyclic aromatic hydrocarbons, and volatile organic compounds. Inhalational exposure to thirdhand smoke includes nicotine, ultrafine particles and volatile organic compounds. Previous studies have shown that inhalational exposure to secondhand cigarette smoke causes endothelial dysfunction, which is a risk factor for heart disease and heart attacks.
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?: