Short Term Effects of Electronic Cigarettes in Tobacco Dependent Adults

Study Overview
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Brief Summary
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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.

Official Title
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Short Term Effects of Electronic Cigarettes in Tobacco Dependent Adults

Conditions
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Smoking, Nicotine Dependence

Intervention / Treatment
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* Other: Nicotine e-cigarette
* Other: Non-nicotine e-cigarette


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Nicotine e-cigarette<br>Patients will receive nicotine patch and intensive counseling plus e-cigarette with nicotine. | Other: Nicotine e-cigarette<br>* Patients will receive nicotine patch and intensive counseling plus e-cigarette with nicotine.<br>|
| Active Comparator: Non-nicotine e-cigarette<br>Patients will receive nicotine patch and intensive counseling plus e-cigarette without nicotine. | Other: Non-nicotine e-cigarette<br>* Patients will receive nicotine patch and intensive counseling plus e-cigarette without nicotine.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in daily quantitative cigarette smoking | Quantitative tobacco cigarette smoking will be measured by experimenter-administered rating scale for 30 days prior to treatment through 6 month follow-up. | baseline, 8 weeks, and 6 months. | 
| Change in exhaled carbon monoxide (CO) levels | Exhaled carbon monoxide levels will be measured with a precision instrument for detecting CO in exhaled breath. | baseline, 8 weeks, and 6 months. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Short-term impact on lung function (spirometry) | Lung function will be measured by spirometry at time of study enrollment and at 6 months. | 6 months |