Electronic Cigarettes as a Harm Reduction Strategy Among Patients With COPD
- Conditions
- COPD
- Interventions
- Other: E-cigarette (EC)Other: Nicotine Replacement Therapy (NRT)Behavioral: Smoking Harm Reduction Counseling Sessions
- Registration Number
- NCT04465318
- Lead Sponsor
- NYU Langone Health
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 146
- an ambulatory ICD-10 code for COPD in the last 12 months and a COPD Assessment Tool (CAT) score on the screening ≥10.
- ages 21-75 (the legal age for purchasing e-cigarettes is 21)
- current CC smokers (more than 5 packs in a lifetime; smokes 4 or more days/week)
- smokes at least 10 cigarettes per day on days they smoke CC
- motivated to quit smoking (at least a 5 on a 10-point Likert scale)
- Participants must be able to provide consent, agree to be randomized and followed-up with, a working telephone number and/or a system with teleconferencing capabilities (e.g. smartphone or computer), a phone with text messaging capabilities, and be willing to use an e-cigarette or NRT for 12 weeks. To reduce attrition, participants will be asked to provide one additional contact as a backup for follow up on appointments.
- A CAT score >30 representing severe COPD
- are pregnant (as determined by urine pregnancy test for women under age 52) or breastfeeding (self-reported). Women of childbearing age must also be willing to use an approved form of birth control during the course of the study if not practicing abstinence. Approved birth control methods include: hormonal birth control (e.g. "the pill"), barrier methods (e.g. condoms, diaphragm), and intrauterine devices (IUDs).
- diagnosis of any medical condition (unstable angina/heart disease) or psychiatric condition precluding use of nicotine patch or gum as determined by the MD of this study, Dr. Scott Sherman (NYS license #171632), or by the subject's primary care doctor.
- reporting using NRTs or e-cigarettes within the last 30 days
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description E-cigarettes (EC) Smoking Harm Reduction Counseling Sessions EC + Counseling E-cigarettes (EC) E-cigarette (EC) EC + Counseling Nicotine Replacement Therapy (NRT) Smoking Harm Reduction Counseling Sessions NRT + Counseling Nicotine Replacement Therapy (NRT) Nicotine Replacement Therapy (NRT) NRT + Counseling
- Primary Outcome Measures
Name Time Method Average change in score on the mMRC Dyspnea Scale Baseline, 12 weeks The mMRC Dyspnea Scale is a self-rating tool that quantifies disability attributable to breathlessness. The score ranges from 0 to 4. The higher the score, the higher the disability of breathlessness poses on day-to-day activities.
Number of participants who achieve 50% reduction in Cigarettes Per Day (CPD) 12 weeks Smoking reduction will be measured by a self-report.
- Secondary Outcome Measures
Name Time Method Change in score of Clinical COPD Questionnaire (CCQ) Baseline, 12 weeks CCQ consists of 10 questions, each scored between 0-6 for a total score range of 0-60. The higher the score, the worse the COPD symptoms and more limitations due to the COPD symptoms.
Number of participants who reported satisfaction with use of e-cigarettes 12 weeks Number of participants who reported additional use of tobacco products and/or marijuana 12 weeks Change in score of COPD Assessment Test (CAT) Baseline, 12 weeks CAT consists of 8 statements, each scored between 0-5 for a total score range of 0-40. The higher the score, the worse the COPD symptoms.
Trial Locations
- Locations (1)
NYU Langone Health
🇺🇸New York, New York, United States