COPDNCT04465318
Electronic Cigarettes as a Harm Reduction Strategy Among Patients With COPD
A study testing E-cigarette (EC), Nicotine Replacement Therapy (NRT) and Smoking Harm Reduction Counseling Sessions in people with COPD, run by NYU Langone Health at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 to 75 years
- Conditions the study is for
- COPD
- What is being tested?
- E-cigarette (EC), Nicotine Replacement Therapy (NRT) and Smoking Harm Reduction Counseling Sessions
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 146 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Nov 2020to 9 Mar 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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
- Being tested
- E-cigarette (EC), Nicotine Replacement Therapy (NRT), Smoking Harm Reduction Counseling Sessions
- Keywords
- E-cigarettes
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive, Vaping
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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 SessionsBehavioural
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)
| Study group | Role | What they receive |
|---|---|---|
| E-cigarettes (EC) | Experimental | EC + Counseling Receives: Other: E-cigarette (EC); Behavioral: Smoking Harm Reduction Counseling Sessions |
| Nicotine Replacement Therapy (NRT) | Active comparator | NRT + Counseling Receives: Other: Nicotine Replacement Therapy (NRT); Behavioral: Smoking Harm Reduction Counseling Sessions |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants who achieve 50% reduction in Cigarettes Per Day (CPD)
Smoking reduction will be measured by a self-report.
Measured: 12 weeks
Average change in score on the mMRC Dyspnea Scale
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.
Measured: Baseline, 12 weeks
Secondary outcomes (4)
Number of participants who reported satisfaction with use of e-cigarettes
Measured: 12 weeks
Number of participants who reported additional use of tobacco products and/or marijuana
Measured: 12 weeks
Change in score of COPD Assessment Test (CAT)
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.
Measured: Baseline, 12 weeks
Change in score of Clinical COPD Questionnaire (CCQ)
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.
Measured: Baseline, 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2020
- Study start9 Nov 2020
- Primary completion8 Mar 2023
- Study completion9 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for COPDStudies of the same condition, open and under way.
- More trials run by NYU Langone HealthThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 146 participants (actual)
Sponsor and investigators
- Lead sponsor
- NYU Langone Health
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Scott E. Sherman, MD, MPH, Principal investigator, NYU Langone HealthElizabeth Stevens, PhD, MPH, Principal investigator, NYU Langone Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04465318
- Sponsor's protocol ID
- 20-00839
- Status last verified
- Jun 2023
- First submitted
- 7 Jul 2020
- Last updated
- 15 Jun 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices) will be shared.
Publications
Rojas SV, Kyanko KA, Wisniewski R, O'Connor K, Li R, Xiang G, Vojjala M, Wilker O, Sherman SE, Stevens ER. Patient perceptions of the use of e-cigarettes in smoking treatment programs: a qualitative analysis. Addict Sci Clin Pract. 2025 May 30;20(1):45. doi: 10.1186/s13722-025-00575-w.
PubMed 40442834Stevens 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.
PubMed 34991693
Study at a glance
From the registry record, last updated by the sponsor on 15 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Electronic Cigarettes as a Harm Reduction Strategy Among Patients With COPD
- ClinicalTrials.gov ID
- NCT04465318
- Acronym / sponsor ID
- 20-00839
- Conditions
- COPD
- Keywords
- E-cigarettes
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 146 participants (actual)
- Lead sponsor
- NYU Langone HealthUniversity, hospital or other
- Study start
- 9 Nov 2020 (actual)
- Primary completion
- 8 Mar 2023 (actual)
- Study completion
- 9 Mar 2023 (actual)
- First posted
- 10 Jul 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| E-cigarettes (EC) | Experimental | Other: E-cigarette (EC), Behavioral: Smoking Harm Reduction Counseling SessionsEC + Counseling |
| Nicotine Replacement Therapy (NRT) | Active comparator | Other: Nicotine Replacement Therapy (NRT), Behavioral: Smoking Harm Reduction Counseling SessionsNRT + Counseling |
Who may qualify
- Ages
- 21 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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)
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 | E-cigarettes (EC) |
| 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. | Other | Nicotine Replacement Therapy (NRT) |
| Smoking Harm Reduction Counseling SessionsCounseling 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) | Behavioural | E-cigarettes (EC), Nicotine Replacement Therapy (NRT) |
Primary outcome
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.
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.
4 secondary outcomes
Number of participants who reported satisfaction with use of e-cigarettes
Time frame: 12 weeks
Number of participants who reported additional use of tobacco products and/or marijuana
Time frame: 12 weeks
Change in score of COPD Assessment Test (CAT)
Time frame: Baseline, 12 weeks
Change in score of Clinical COPD Questionnaire (CCQ)
Time frame: Baseline, 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jun 2023.
- Derived from this study: PubMed 40442834Rojas SV, Kyanko KA, Wisniewski R, O'Connor K, Li R, Xiang G, Vojjala M, Wilker O, Sherman SE, Stevens ER. Patient perceptions of the use of e-cigarettes in smoking treatment programs: a qualitative analysis. Addict Sci Clin Pract. 2025 May 30;20(1):45. doi: 10.1186/s13722-025-00575-w.
- Derived from this study: PubMed 34991693Stevens 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.
- Individual participant dataSharing planned: Yes. Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices) will be shared.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Scott E. Sherman, MD, MPH principal investigator
NYU Langone Health
Elizabeth Stevens, PhD, MPH principal investigator
NYU Langone Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing E-cigarette (EC), Nicotine Replacement Therapy (NRT) and Smoking Harm Reduction Counseling Sessions in people with COPD, run by NYU Langone Health at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants who achieve 50% reduction in Cigarettes Per Day (CPD) (time frame: 12 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04465318, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jun 2023.