Effects of Electronic Cigarettes on Nicotine Concentrations



Status:Completed
Conditions:Healthy Studies
Therapuetic Areas:Other
Healthy:No
Age Range:18 - 55
Updated:12/2/2017
Start Date:October 2012
End Date:June 2015

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

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.

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.

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
We found this trial at
1
site
263 Farmington Ave
Farmington, Connecticut 06030
(860) 679-2000
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