Nicotine Dependence, Smoking
Conditions
Brief summary
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.
Interventions
OTHERNicotine e-cigarette
Patients will receive nicotine patch and intensive counseling plus e-cigarette with nicotine.
Patients will receive nicotine patch and intensive counseling plus e-cigarette without nicotine.
Sponsors
Yale University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in daily quantitative cigarette smoking | baseline, 8 weeks, and 6 months. | Quantitative tobacco cigarette smoking will be measured by experimenter-administered rating scale for 30 days prior to treatment through 6 month follow-up. |
| Change in exhaled carbon monoxide (CO) levels | baseline, 8 weeks, and 6 months. | Exhaled carbon monoxide levels will be measured with a precision instrument for detecting CO in exhaled breath. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Short-term impact on lung function (spirometry) | 6 months | Lung function will be measured by spirometry at time of study enrollment and at 6 months. |
Countries
United States
Outcome results
None listed