Clinical trial NCT04465318: Electronic Cigarettes as a Harm Reduction Strategy Among Patients With COPD
Official title: Electronic Cigarettes as a Harm Reduction Strategy Among Patients With COPD
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: COPD
Keywords: E-cigarettes
Lead sponsor: NYU Langone Health
Sponsor class: OTHER
First posted: 2020-07-10
Enrollment: 146
Sex: ALL
Minimum age (years): 21
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: Inclusion Criteria:

1. an ambulatory ICD-10 code for COPD in the last 12 months and a COPD Assessment Tool (CAT) score on the screening ≥10.
2. ages 21-75 (the legal age for purchasing e-cigarettes is 21)
3. current CC smokers (more than 5 packs in a lifetime; smokes 4 or more days/week)
4. smokes at least 10 cigarettes per day on days they smoke CC
5. motivated to quit smoking (at least a 5 on a 10-point Likert scale)
6. 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.

Exclusion Criteria:

1. A CAT score \>30 representing severe COPD
2. 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).
3. 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.
4. reporting using NRTs or e-cigarettes within the last 30 days

Primary outcomes:
measure: Number of participants who achieve 50% reduction in Cigarettes Per Day (CPD)
timeFrame: 12 weeks
measure: Average change in score on the mMRC Dyspnea Scale
timeFrame: Baseline, 12 weeks
Secondary outcomes:
measure: Number of participants who reported satisfaction with use of e-cigarettes
timeFrame: 12 weeks
measure: Number of participants who reported additional use of tobacco products and/or marijuana
timeFrame: 12 weeks
measure: Change in score of COPD Assessment Test (CAT)
timeFrame: Baseline, 12 weeks
measure: Change in score of Clinical COPD Questionnaire (CCQ)
timeFrame: Baseline, 12 weeks
Other outcomes:
Locations:
city: New York
country: United States
facility: NYU Langone Health
state: New York
Study officials:
affiliation: NYU Langone Health
name: Scott E. Sherman, MD, MPH
role: PRINCIPAL_INVESTIGATOR
affiliation: NYU Langone Health
name: Elizabeth Stevens, PhD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
citation: Stevens ER, Lei L, Cleland CM, Vojjala M, El-Shahawy O, Berger KI, Kirchner TR, Sherman SE. Electronic cigarettes as a harm reduction strategy among patients with COPD: protocol for an open-label two arm randomized controlled pilot trial. Addict Sci Clin Pract. 2022 Jan 6;17(1):2. doi: 10.1186/s13722-021-00284-0.