Ignite Creation Date:
2024-07-17 @ 11:44 AM
Last Modification Date:
2024-10-26 @ 3:33 PM
Study NCT ID:
NCT06472869
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-06-25
First Post:
2024-06-19
Brief Title:
Assessing E-Cigarettes for Tobacco Harm Reduction in the Context of Lung Cancer Screening
Sponsor:
Massachusetts General Hospital
Organization:
Massachusetts General Hospital
Study Overview
Official Title:
Assessing E-Cigarettes for Tobacco Harm Reduction in the Context of Lung Cancer Screening
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-06
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:
This study investigates the feasibility acceptability and short-term effects of providing 4 weeks of complimentary electronic cigarettes ECs to 30 individuals who did not quit after smoking cessation treatment provided in the context of lung cancer screening and do not plan to quit smoking This open-label single-arm pilot clinical trial will test the impact of EC provision on 1 study feasibility 2 EC acceptability 3 tobacco use behavior eg cigarettes per day EC use and 4 biomarkers eg carbon monoxide cotinine and anabasine Participants will be asked to switch from combustible cigarettes to the NJOY ACE 5 nicotine electronic cigarette EC for 4 weeks They will be followed an additional 4 weeks after EC provision ends to 8 weeks
The first study hypothesis is that more than 40 of eligible smokers who are offered participation in the trial will enroll and that 75 of enrollees will complete the trial The second study hypothesis is that participants will report fewer cigarettes smoked per day at the end of 4 weeks of EC provision relative to their baseline values
The first study hypothesis is that more than 40 of eligible smokers who are offered participation in the trial will enroll and that 75 of enrollees will complete the trial The second study hypothesis is that participants will report fewer cigarettes smoked per day at the end of 4 weeks of EC provision relative to their baseline values
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