NCT04465318

Electronic Cigarettes as a Harm Reduction Strategy Among Patients With COPD

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 146 (actual)
• Sponsor: NYU Langone Health · Academic / Other
• Sex: All
• Age: 21 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Conditions

• COPD

Interventions

Type	Name	Description
OTHER	E-cigarette (EC)	NJOY Daily E-cigarettes are self-contained and non-refillable. Each DAILY provides approximately 300 puffs, comparable to a full pack of cigarettes.
OTHER	Nicotine Replacement Therapy (NRT)	Participants in the NRT arm will receive 21 mg nicotine patch (for those with CPD \>= 20) or 14 mg nicotine patch (for those with CPD \< 20) + 4 mg nicotine gum. CPD stands for Cigarettes Per Day.
BEHAVIORAL	Smoking Harm Reduction Counseling Sessions	Counseling will cover health education, social support issues, and motivational enhancement to improve self-efficacy while addressing other aspects know to contribute to smoking among people with COPD (e.g., tips on dealing with depression)

Timeline

• Start date: 2020-11-09
• Primary completion: 2023-03-08
• Completion: 2023-03-09
• First posted: 2020-07-10
• Last updated: 2023-06-15

Locations

1 site across 1 country: United States