Ignite Creation Date:
2024-05-06 @ 8:15 PM
Last Modification Date:
2024-10-26 @ 3:23 PM
Study NCT ID:
NCT06310187
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-03-15
First Post:
2024-03-07
Brief Title:
Little Cigar Oxidants
Sponsor:
Milton S Hershey Medical Center
Organization:
Milton S Hershey Medical Center
Study Overview
Official Title:
Oxidative Stress and Harmful Constituent Levels Associated with Little Cigars
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-09
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:
Determine the effects of little cigars on human exposure to tobacco smoke oxidants In a balanced randomized cross-over study design in cigarette smokers subjects will be assigned to 6 exposure groups These include a high oxidant unflavored little cigar exposure condition a low oxidant unflavored little cigar exposure condition a high oxidant flavored exposure condition a low oxidant flavored exposure little cigar exposure condition their usual cigarette and a control condition unlit little cigar Following the smoking of each product exhaled breath condensate samples will be collected at baseline 30 60 90 120 and 150 minutes Samples will be analyzed for levels of oxidant markers including hydrogen peroxide 8-isoprostanes and C-reactive protein as well as nicotine 4-methylnitrosamino-1-3-pyridyl-1-butanone NNK and N-nitrosonornicotine NNN
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
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?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| U54DA058271-01 | NIH | None | httpsreporternihgovquickSearchU54DA058271-01 |