Comparison of Pharmacokinetic Parameters Between Adopters of Electronic Cigarettes and a Historic… (NCT02730676) | Clinical Trial Compass
CompletedNot Applicable
Comparison of Pharmacokinetic Parameters Between Adopters of Electronic Cigarettes and a Historical Sample of Combustible Cigarette Smokers
United States44 participantsStarted 2016-04
Plain-language summary
This study assesses the nicotine pharmacokinetic (PK) parameters in adopters of electronic cigarettes following a 12-hour tobacco and nicotine abstinence. The PK results of this study will be compared to historical data on smokers obtained in prior studies, as well as on naïve and short-term users of electronic cigarettes.
Who can participate
Age range21 Years – 60 Years
SexALL
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Inclusion criteria
✓. Able to read, understand, and willing to sign an Informed Consent Form (ICF) and complete questionnaires written in English;
✓. Generally healthy males and females, 21 to 60 years of age, inclusive, at Screening Visit;
✓. Breath expired carbon monoxide (ECO) level is \<10 parts per million (ppm) at the Screening Visit and Visit Day 1;
✓. Positive urine cotinine test at the Screening Visit and Visit Day 1;
✓. Electronic cigarettes are the only form of tobacco- or nicotine-containing product used within 30 days of Screening;
✓. Willing to use VUSE digital vapor cigarettes during the study according to protocol;
✓. Willing to be confined overnight and abstain from tobacco- and nicotine-containing product use for 12 hours prior to investigational product use through Study Discharge;
✓. Females of childbearing age must be willing to use a form of contraception acceptable to the Investigator from the time of signing the ICF until Study Discharge, or be surgically sterile for at least 90 days prior to the Screening Visit;
Exclusion criteria
✕. Presence of clinically significant or unstable/uncontrolled acute or chronic medical conditions at the Screening Visit, as determined by the Investigator, that would preclude a subject from participating safely in the study (e.g., uncontrolled hypertension, asthma or other lung disease, cardiac disease, neurological disease, or psychiatric disorders) based on safety assessments such as clinical laboratory tests, medical history, and physical/oral examinations;
What they're measuring
1
Nicotine pharmacokinetics with respect to initiation of in-clinic investigational product use following a 12-hour tobacco and nicotine abstinence