Electronic Cigarettes as a Harm Reduction Strategy Among Patients With COPD

NCT04465318 | Completed

• 1 other identifier: 20-00839
• Study Type: interventional
• Target: 146
• Locations: 1 country
• Sites: 1

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.

Conditions

COPD

Keywords

E-cigarettes

Outcome Measures

Primary Outcomes (2)

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

  Smoking reduction will be measured by a self-report.

  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.

  Baseline, 12 weeks

Secondary Outcomes (4)

• 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

• Change in score of Clinical COPD Questionnaire (CCQ)

  Baseline, 12 weeks

Study Arms (2)

E-cigarettes (EC)

EXPERIMENTAL

EC + Counseling

Other: E-cigarette (EC); Behavioral: Smoking Harm Reduction Counseling Sessions

Nicotine Replacement Therapy (NRT)

ACTIVE COMPARATOR

NRT + Counseling

Other: Nicotine Replacement Therapy (NRT); Behavioral: Smoking Harm Reduction Counseling Sessions

Interventions

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.

E-cigarettes (EC)

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.

Nicotine Replacement Therapy (NRT)

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)

E-cigarettes (EC); Nicotine Replacement Therapy (NRT)

Eligibility Criteria

• Age: 21 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• NYU Langone Health: lead

Study Sites (1)

NYU Langone Health

New York, New York, 10016, United States

Location

Related Publications (2)

• 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.

  PMID: 40442834 DERIVED

• 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.

  PMID: 34991693 DERIVED

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive; Vaping

Interventions

Electronic Nicotine Delivery Systems; Nicotine Replacement Therapy

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Smoking; Behavior

Intervention Hierarchy (Ancestors)

Smoking Devices; Manufactured Materials; Technology, Industry, and Agriculture; Drug Therapy; Therapeutics

Study Officials

• Scott E. Sherman, MD, MPH

  NYU Langone Health

  PRINCIPAL INVESTIGATOR

• Elizabeth Stevens, PhD, MPH

  NYU Langone Health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 7, 2020
• First Posted: July 10, 2020
• Study Start: November 9, 2020
• Primary Completion: March 8, 2023
• Study Completion: March 9, 2023
• Last Updated: June 15, 2023

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research.
• Access Criteria: The investigator who proposed to use the data will have access to the data upon reasonable request. Requests should be directed to scott.sherman@nyulangone.org. To gain access, data requestors will need to sign a data access agreement.

Locations

US (1)