Ignite Creation Date:
2024-05-06 @ 7:53 PM
Last Modification Date:
2024-10-26 @ 3:16 PM
Study NCT ID:
NCT06179290
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-01-05
First Post:
2023-12-12
Brief Title:
Changes in Biomarker of Exposure in Adults Who Smoke Cigarettes Switching From Cigarettes to Heated Tobacco Products
Sponsor:
Altria Client Services LLC
Organization:
Altria Client Services LLC
Study Overview
Official Title:
A Multi-site Open-Label Parallel-Group Study To Evaluate Changes In Tobacco-Related Biomarkers of Exposure and Biomarkers of Potential Harm With Use of Heated Tobacco Products Compared to Combustible Cigarettes in Adult Smokers
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-08
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 the study is to evaluate changes in biomarkers of exposure BoE to harmful and potentially harmful constituents HPHCs in adult smokers who completely switch to Ploom heated tobacco products HTPs compared to those who continue to smoke usual brand combustible cigarettes UBCC
Detailed Description:
This is a multi-site open-label two-group menthol and non-menthol six-arm HTP Continue Smoking and Smoking Abstinence arms within each group randomized clinical study to evaluate changes in BoEs in adult smokers who remain smoking switch to the Ploom HTP or abstain from smoking for 60 days 5 days in clinic followed by a 55-day ambulatory phase Target enrollment is 300 male and female adult smokers between the ages of 22 and 65 in overall good health
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?:
False
Is an FDA AA801 Violation?:
None