Ignite Creation Date:
2025-12-24 @ 11:05 PM
Ignite Modification Date:
2026-01-02 @ 12:12 AM
Study NCT ID:
NCT06472869
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-08-01
First Post:
2024-06-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Assessing E-Cigarettes for Tobacco Harm Reduction in the Context of Lung Cancer Screening
Sponsor:
Massachusetts General Hospital
Organization:
Study Overview
Official Title:
Assessing E-Cigarettes for Tobacco Harm Reduction in the Context of Lung Cancer Screening
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2025-01
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 (e.g., cigarettes per day, EC use), and 4) biomarkers (e.g., 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:
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?:
False
Is an FDA AA801 Violation?: