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Note: This study is currently only recruiting patients in the hospital.

If you are interested in being notified if this study begins recruiting from the general population, please use the 'I Am Interested' button below.

The effects of electronic cigarette use on smokers with chronic obstructive pulmonary disease (COPD)

We are conducting a study looking at the effects of electronic cigarettes on cigarette smoking and lung function in smokers with chronic obstructive pulmonary disease who do not plan to quit smoking within the next 30 days.

10 hours over 7 visits
Estimated Time Commitment
Any Sex/Gender, 40-80 years
May Be Eligible
Payment up to $275
May Be Offered
Survey, Office visit
May Be Required
 
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This project is not recruiting.

What we are studying

Our research is looking at what happens to smoking habits and lung function in smokers with chronic obstructive pulmonary disease (COPD, sometimes also referred to as chronic bronchitis or emphysema) who switch from smoking cigarettes to using electronic cigarettes. A first step in understanding the safety of these products is observing how much smokers substitute their cigarette use with electronic cigarette use, and how this affects symptoms or lung function.


Why it is important

Nearly half of all smokers in the US have used electronic cigarettes before. Since electronic cigarettes are still relatively new, it is not well known how they affect health. Smokers with COPD smoke at higher rates than most adults in the United States, and many of these smokers have tried electronic cigarettes. This study will help us better understand how electronic cigarettes may affect cigarette smoking and short-term health.


What we hope to accomplish

This research aims to understand how much smokers who are provided with electronic cigarettes replace their regular cigarette smoking with electronic cigarette use. We also hope to learn how electronic cigarettes are tolerated by people who use them, and whether there are any important safety concerns with their use.

Principal Investigator

Sara Kalkhoran, MD MAS

Massachusetts General Hospital

Public Profile

 


·         Between ages of 40 and 80


·         At least 10 pack year smoking history


·         Daily use of at least 5 cigarettes


·         Diagnosis of mild or moderate chronic obstructive pulmonary disease (COPD)


·         No plan to quit cigarettes within the next 30 days


·         English-speaking

 


·         Past 30 day use of nicotine containing products (cigars, cigarillos, hookah, pipe tobacco, electronic cigarettes, smokeless tobacco, nicotine replacement therapy)


·         Past-30 day use of inhaled recreational drugs (marijuana, crack)


·         Pulmonary disease other than COPD or asthma (e.g. interstitial lung disease, sarcoidosis)


·         Ever requiring mechanical ventilation (also known as a breathing tube)


·         2 or more hospitalizations for COPD in the past 12 months


·         Hospitalization for a heart problem in the past 6 months


·         Pregnant or breast feeding


·         Individuals who use oxygen therapy

As part of the study, you will be asked to make 6 or 7 visits to MGH over the course of 6 or 9 months. You will receive an electronic cigarette with cartridge refills and be asks to replace your cigarettes with the electronic cigarette as best you can.  The visits will include:


·         Filling out a variety of surveys about your smoking and breathing


·         Getting your vital signs taken (e.g. blood pressure, heart rate)


·         Giving a urine sample


·         A breathing test called spirometry


·         A breathing test to look at carbon monoxide levels


·         Returning any used and unused electronic cigarette cartridge refills


Project activities may include:

  • Survey
  • Office visit

Estimated Time Commitment

10 hours over 7 visits


Participants will be compensated up to $245-$275, depending on the number of study visits completed. All participants will be provided with electronic cigarette devices and refills, at no charge to them, for use during the study. Parking vouchers will also be provided for each visit.

Translational and Clinical Research Center on White 12 MGH Main Campus, 55 Fruit St Boston, MA 02114

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Travel

  • Accessible by public transportation
  • Parking available
  • Parking reimbursed

Travel and Parking Details


ClinicalTrials.gov Identifier

NCT03379025


Participating Institutions


Funding Source

  • NIH or Other Federal
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