Ignite Creation Date:
2024-05-06 @ 6:26 PM
Last Modification Date:
2024-10-26 @ 2:48 PM
Study NCT ID:
NCT05664672
Status:
COMPLETED
Last Update Posted:
2022-12-27
First Post:
2022-12-16
Brief Title:
Study to Evaluate Changes in Smokers Using on Nicotine Pouches
Sponsor:
Altria Client Services LLC
Organization:
Altria Client Services LLC
Study Overview
Official Title:
A Randomized Controlled Open-label Short-term Study to Evaluate Changes in Exposure to Harmful and Potentially Harmful Constituents in Adult Smokers Who Completely Switch to on Nicotine Pouches in a Clinical Setting
Status:
COMPLETED
Status Verified Date:
2022-12
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:
The purpose of this study is to generate evidence regarding the extent of reduction in exposure to selected HPHCs in adult smokers switching to on NPs The study intends to determine changes in exposure to selected HPHCs by measuring biomarkers in adult smokers who completely switch from smoking to use of on NP compared to those who continue smoking cigarettes or stop using all tobacco products
Detailed Description:
This is an open-label randomized 5 parallel-group clinical study evaluating changes in exposure to selected harmful and potentially harmful constituents HPHCs and product use behavior in adult smokers who are randomly assigned to 1 of the 5 groups continue smoking partially or completely switch to oral tobacco-derived nicotine products or stop using any tobacco products for 7 days
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