Short Term Effects of Electronic Cigarettes in Tobacco Dependent Adults
Status
Conditions
Treatments
Details and patient eligibility
About
This is a pilot human experimental study to evaluate whether the use of an e-cigarette affects lung function, exhaled CO levels, and quantitative tobacco cigarette consumption in active tobacco smokers. Subjects recruited from the Winchester Chest Clinic (WCC), Adult Primary Care Clinic (PCC) and the Smilow Cancer Hospital Smoking Cessation Service will be randomized to 1 of 2 groups: (1) nicotine patch and intensive counseling (standard care) plus nicotine e-cigarette; (2) nicotine patch and intensive counseling plus non-nicotine e-cigarette.
Enrollment
Sex
Ages
Volunteers
Inclusion and exclusion criteria
Inclusion:
- Smoking 1 or more tobacco cigarettes per day.
- Residence within reasonable driving distance to New Haven..
Exclusion:
- Unstable psychiatric conditions such as suicidal ideation, acute psychosis, severe alcohol dependence, or dementia.
- Unstable medical conditions requiring hospitalization.
- Acute myocardial infarction or acute cerebrovascular accident within the past 30 days.
- Unstable angina.
- History of allergic reactions to adhesives.
- Women of childbearing potential who are pregnant, nursing, or not practicing effective contraception.
- Current use of an electronic cigarette.
- Subject unable or unwilling to complete study protocol for any reason.
Trial design
Primary purpose
Allocation
Interventional model
Masking
40 participants in 2 patient groups
Trial contacts and locations
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Data sourced from clinicaltrials.gov
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