Effects of Electronic Cigarettes on Nicotine Concentrations

Study Overview
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Brief Summary
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This study will examine whether nicotine levels increase with electronic cigarettes. It will also examine whether electronic cigarettes alter lung function tests. The study will obtain preliminary data on the medical effects of electronic cigarettes, with two different nicotine flavors, tobacco and tobacco with menthol, which are available for over the counter purchase. The electronic cigarettes and juice used in this study is available for purchase through the internet. An investigational new drug application (IND) is not needed for this study.

Detailed Description
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This is a randomized two-period cross-over study in which subjects who smoke greater than 10 cigarettes will be instructed to quit smoking and use either Joye (Ego C brand) with an 18 mg cartridge containing either a tobacco or tobacco mentholated flavor for one week. Prior to starting e-cig use we will collect one blood sample for nicotine/cotinine as a measure of overall nicotine exposure. Subjects will use the device for one week and at the end of approximately one week of use, we will assess nicotine/cotinine concentrations (before and 5, 10, 15, 20 and 30 minutes after the onset of ECIG use), pulmonary function tests (before and 5 minutes after ECIG use), and subjective impressions of satisfaction. At the end of one week, subjects will be crossed over to the other condition and assessments will be repeated after another week of E-cigarette use. A total of 30 smokers will be recruited from the surrounding areas via advertisements in newspapers and radio advertisements and University of Connecticut Health Center (UCHC) broadcast e-mail. Posters will be placed in clinical areas to recruit from physician practices. Current smokers are being proposed for three reasons: 1) we wish to determine whether nicotine levels from e-cigarettes rise to the levels of regular cigarettes when used by regular smokers; 2) we wish to determine if there are any differences seen in pulmonary function when a person switches from regular cigarettes to e-cigarettes; 3) we wish to evaluate the level of satisfaction that regular smokers have with e-cigarettes. All of these questions will have implications for later, more extensive studies of e-cigarettes, particularly in regard to their utility as a smoking cessation modality. Once a potential study subject calls and expresses interest in the study, preliminary inclusion criteria will be assessed over the phone. Inclusion criteria include 1) at least 18 years of age; 2) current use of at least 10 cigarettes daily; 3) willing to abstain from cigarette smoking, and substitute e-cigs, for approximately 2 weeks; 4) able to read and sign a consent form; Exclusion criteria: 1) unstable medical or psychiatric disorders as determined by the principal investigator; 2) pregnancy; 3) known hypersensitivity to nicotine or propylene glycol or menthol; 4) previous myocardial infarction (M.I.) or stroke; 5) uncontrolled hypertension [Blood pressure (BP) >160/100); 6) insulin dependent diabetes; 7) known chronic obstructive pulmonary disease (COPD) or asthma.

Official Title
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Effects of Electronic Cigarettes on Nicotine Concentrations Before and 5, 10, 15, 20 and 30 Minutes After Use

Conditions
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Health Behavior

Intervention / Treatment
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* Drug: Nicotine with Tobacco Flavor and Tobacco & Menthol Flavor


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Smoking 10 cigarettes daily Agree to abstain from smoking and use electronic cigarettes for 2 weeks Exclusion Criteria: Unstable medical or psychiatric disorders as determined by the principal investigator Pregnancy Known hypersensitivity to nicotine or propylene glycol or menthol Recent M. I. or stroke Uncontrolled hypertension (BP.>160/100) Insulin dependent diabetes Known COPD or asthma Alcohol or other drug abuse or dependence

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Tobacco Flavor/ Tobacco & Menthol Flavor<br>Subjects randomized to Tobacco Flavor group 7-10 days, then crossed over to Tobacco and Menthol Flavor for 7-10 days. Nicotine with Tobacco Flavor and Tobacco & Menthol Flavor (18mg/mL nicotine) | Drug: Nicotine with Tobacco Flavor and Tobacco & Menthol Flavor<br>* Subjects randomized to either Tobacco Flavor group for 7-10 days than crossed over to Tobacco & Menthol Flavor for 7-10 days or Tobacco & Menthol Flavor group for 7-10 days than crossed over to Tobacco Flavor for 7-10 days<br>* Other names: Nicotine;|
| Other: Tobacco & Menthol Flavor/Tobacco Flavor<br>Subjects randomized to Tobacco and Menthol Flavor for 7-10 days,then crossed over to Tobacco Flavor for 7-10 days. Nicotine with Tobacco Flavor and Tobacco & Menthol Flavor (18mg/mL nicotine) | Drug: Nicotine with Tobacco Flavor and Tobacco & Menthol Flavor<br>* Subjects randomized to either Tobacco Flavor group for 7-10 days than crossed over to Tobacco & Menthol Flavor for 7-10 days or Tobacco & Menthol Flavor group for 7-10 days than crossed over to Tobacco Flavor for 7-10 days<br>* Other names: Nicotine;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Effects E-cig Use on Venous Nicotine Concentrations Before and 5 Minutes After Use | To determine the effects of acute E-cig use on venous nicotine concentrations 5 minutes before and 5 minutes after 7-10 days of e-cigarette use. | 7-10 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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smoking