Smoking Cessation Clinical Trial
Official title:
Adverse Airway Effects of Inhaled Nicotine From Tobacco and E-Cigarettes
Verified date | August 2017 |
Source | Miami VA Healthcare System |
Contact | Michael Campos, MD |
mcampos1[@]med.miami.edu | |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The purpose of the study conducted at VA Medical Center in Miami is to determine if smoking
electronic cigarettes (known as e-cigarettes) that contain nicotine have less negative
effects than regular cigarettes on the person's respiratory health. We will assess this by
measuring pulmonary function tests, several body molecules and functionality of the airway
cells. We will also evaluate how smokers can maintain exclusive electronic cigarettes use.
In this study, some people will continue to smoke regular tobacco cigarettes while others
will switch to a nicotine-containing electronic cigarette.
Status | Recruiting |
Enrollment | 200 |
Est. completion date | March 28, 2021 |
Est. primary completion date | March 28, 2021 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Subjects that actively smoke and have a history of at least 5 pack-years Exclusion Criteria: - HIV,marijuana use, asthma and other concomitant inflammatory pulmonary disorders, subjects with known pulmonary diseases including malignancies, subjects with prior thoracic surgery and subjects that used oral corticosteroids or antibiotics within the prior 3 months, subjects with allergies to study medications and subjects incapable of providing informed consent. |
Country | Name | City | State |
---|---|---|---|
United States | Miami VA Healthcare System | Miami | Florida |
Lead Sponsor | Collaborator |
---|---|
Miami VA Healthcare System |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change in nasal potential difference (NPD) | nasal potential difference (NPD) before and after replacing tobacco cigarettes with electronic cigarettes | 11 weeks of transitioning | |
Secondary | change in Inflammatory markers smoking to electronic cigarettes | TGF-ß levels in nasal secretions before and after replacing tobacco cigarettes with electronic cigarettes | 11 weeks of transitioning |
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