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OpenTrials
Completed

NCT Number: NCT04465318

Electronic Cigarettes as a Harm Reduction Strategy Among Patients With COPD

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.

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Key information

Age range

21 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

NYU Langone Health

New York, 10016, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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

Treatment and study plan

E-Cigarette (EC)

Other

NJOY Daily E-cigarettes are self-contained and non-refillable. Each DAILY provides approximately 300 puffs, comparable to a full pack of cigarettes.

Nicotine replacement therapy (NRT)

Other

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.

Smoking Harm Reduction Counseling Sessions

Behavioral

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)

Primary outcomes

  1. Number of participants who achieve 50% reduction in Cigarettes Per Day (CPD)

    Time frame: 12 weeks

    Smoking reduction will be measured by a self-report.

  2. Average change in score on the mMRC Dyspnea Scale

    Time frame: 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.

Secondary outcomes

  1. Number of participants who reported satisfaction with use of e-cigarettes

    Time frame: 12 weeks

  2. Number of participants who reported additional use of tobacco products and/or marijuana

    Time frame: 12 weeks

  3. Change in score of COPD Assessment Test (CAT)

    Time frame: 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.

  4. Change in score of Clinical COPD Questionnaire (CCQ)

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

NYU Langone Health

Other

Registry information

Important dates

Study start
2020
Primary completion
2023
Study completion
2023
First posted
Jul 10, 2020
Registry last updated
Jun 15, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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