Comparison of Pharmacokinetic Parameters Between Adopters of Electronic Cigarettes and a Historical Sample of Combustible Cigarette Smokers

Exclusion Criteria

• •1. 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;
• •2. Self-reports or safety labs indicate diabetes;
• •3. At risk for heart disease, as determined by the Investigator;
• •4. Use of medicine for treatment of depression or asthma;
• •5. Systolic blood pressure of ≥150 mmHg or a diastolic blood pressure of ≥95 mmHg, measured after being seated for 5 minutes;
• •6. Hemoglobin level \<12 g/dL at the Screening Visit;
• •7. Positive test for human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg), or hepatitis C virus antibody (anti-HCV);
• •8. History or presence of hemophilia or other bleeding disorders;
• •9. History or presence of clotting disorders with concomitant use of anticoagulants;
• •10. Given a whole blood donation in the 8 weeks (≤56 days) prior to the Screening Visit;
• •11. Plasma donation within ≤7 days prior to the Screening Visit;
• •12. Body mass index \<18.5 or \>40.0 kg/m2 at the Screening Visit;
• •13. Weight of ≤110 pounds;
• •14. Poor peripheral venous access;
• •15. Postponing a decision to quit use of nicotine or tobacco products (defined as planning a quit attempt within 30 days of the Screening Visit) to participate in this study;
• •16. Use of any medication or substance that aids in smoking cessation, including but not limited to any nicotine replacement therapy (e.g., nicotine gum, lozenge, patch), varenicline (Chantix®), bupropion (Wellbutrin®, Zyban®), or lobelia extract within 30 days prior to the Screening Visit;
• •17. Females who test positive for pregnancy, are pregnant or breastfeeding, or plan to become pregnant during the course of the study;
• •18. A positive urine drug screen without disclosure of corresponding concomitant medication(s) at the Screening Visit or on Visit Day 1;
• •19. A positive alcohol breathalyzer result at Screening or on Visit Day 1;
• •20. Self-reports drinking more than 14 servings of alcoholic beverages per week (1 serving = 12 oz. of beer, 6 oz. of wine, or 1 oz. of liquor);
• •21. Participation in another clinical trial within 30 days prior to the Screening Visit, as determined from the last visit of the prior trial to the first Screening Visit in this study;
• •22. Employed by a tobacco or nicotine company, the study site, or handled tobacco or nicotine products as part of your job.