Status:
COMPLETED
Electronic Cigarettes as a Harm Reduction Strategy Among Patients With COPD
Lead Sponsor:
NYU Langone Health
Conditions:
COPD
Eligibility:
All Genders
21-75 years
Phase:
NA
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 mor...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
November 9 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 9 2023
Estimated Enrollment :
146 Patients enrolled
Trial Details
Trial ID
NCT04465318
Start Date
November 9 2020
End Date
March 9 2023
Last Update
June 15 2023
Active Locations (1)
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1
NYU Langone Health
New York, New York, United States, 10016