University of Connecticut Health Center Underway With New Study

• Effects of E-cig use on measures of pulmonary resistance before and 5 minutes after use [ Time Frame: 7-10 days ] [ Designated as safety issue: No ]
• To determine the acute effects of E-cig use before and 5 minutes after use on measures of pulmonary resistance after 7-10 days of product use.

• Comparing smoking vs. e-cigarette use [ Time Frame: 14-20 days ] [ Designated as safety issue: No ]
• To obtain preliminary data comparing smoking vs. e-cigarette use on 1) overall nicotine exposure as measured by cotinine; 2) nicotine cravings and on expectancies; 3) resting pulmonary function tests as measured by body plethysmography; 4) effects on pulmonary function testing with tobacco with and without menthol flavoring.

Detailed Description:

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 devise for one week and at the end of approximately one week of use, we will assess nicotine/cotinine concentrations (before and 5, 1015,20 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 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.

Since the said study started in October of 2012, the results are yet to be said. The study is set to be completed sometime in April of 2014. Though it is a long wait, the results are needed and will play a big part in the electronic cigarette industry.

Read more: http://clinicaltrials.gov/ct2/show/NCT01775787