Ignite Creation Date:
2025-12-25 @ 5:03 AM
Ignite Modification Date:
2026-03-01 @ 3:52 PM
Study NCT ID:
NCT04465318
Status:
COMPLETED
Last Update Posted:
2023-06-15
First Post:
2020-07-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Electronic Cigarettes as a Harm Reduction Strategy Among Patients With COPD
Sponsor:
NYU Langone Health
Organization:
Study Overview
Official Title:
Electronic Cigarettes as a Harm Reduction Strategy Among Patients With COPD
Status:
COMPLETED
Status Verified Date:
2023-06
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:
The study team proposes a two-arm pilot study randomizing participants with COPD who smoke combustible cigarettes (CC) to counseling + NRT (standard of care) or counseling + e-cigarettes.
Detailed Description:
Globally, chronic obstructive pulmonary disease (COPD) is projected to be the third largest cause of death by 2030 and in the US over 16 million people have COPD. Smokers are four and a half times more likely to develop COPD than non-smokers, with the likelihood of COPD increasing progressively with the duration and intensity of smoking. Among those with COPD, smoking cessation is the most effective means of slowing the decline of lung function and overall disease progression. Patients at all stages of COPD benefit from quitting smoking. Over 90% of COPD deaths occur in current smokers, however 47.1% of people with COPD continue to smoke. Electronic cigarettes (E-cigarettes) could help people reduce the harm of combustible cigarettes (CC) through reductions in number of Cigarettes per Day (CPD) or quitting CC completely by addressing both nicotine and behavioral dependence. Although there are associated health risks, all available evidence indicates that E-cigarettes are safer than CC. Unlike CC, e-cigarettes are not associated with coronary heart disease or myocardial infarction. The purpose of this mixed methods study is to identify barriers and facilitators, as well as to assess preliminary effectiveness of e-cigarettes as a harm reduction strategy among people with COPD.
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?:
None
Is an FDA AA801 Violation?: