Clinical trial NCT02730676: Comparison of Pharmacokinetic Parameters Between Adopters of Electronic Cigarettes and a Historical Sample of Combustible Cigarette Smokers
Official title: A Study to Assess Nicotine Pharmacokinetic Parameters of Digital Vapor Cigarettes in Adopters and Compare Them to Nicotine Pharmacokinetic Parameters of Cigarettes in Smokers
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Smoking
Keywords: electronic cigarettes
e-cigarette
combustible cigarette
cigarette
menthol
cig-alike
subjective measures
pharmacokinetics
craving
Lead sponsor: R.J. Reynolds Vapor Company
Sponsor class: INDUSTRY
Collaborators: name: Davita Clinical Research
name: RAI Services Company
First posted: 2016-04-06
Enrollment: 44
Sex: ALL
Minimum age (years): 21
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Generally healthy males and females 21 to 60 years of age who are exclusive users of electronic cigarettes.

Brief 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.

Detailed description: This is an observational, open-label study to assess the nicotine pharmacokinetic (PK) parameters over a 6-hour period in adopters of electronic cigarettes with respect to an in-clinic 10-minute ad libitum period following a 12-hour tobacco and nicotine abstinence. In addition to PK parameters, subjective effects of urge for product will be assessed over a 6-hour period concurrently with the collection of the PK blood samples following a protocol defined schedule. The results of this study will be compared to historical PK and urge for product data obtained from smokers as well as naïve and short-term users of electronic cigarettes. In addition to the PK parameters and urge for product outcomes, plasma will be assessed for cotinine concentration prior to the 12-hour abstinence period.

Eligibility criteria: Inclusion Criteria:

1. Able to read, understand, and willing to sign an Informed Consent Form (ICF) and complete questionnaires written in English;
2. Generally healthy males and females, 21 to 60 years of age, inclusive, at Screening Visit;
3. Breath expired carbon monoxide (ECO) level is \<10 parts per million (ppm) at the Screening Visit and Visit Day 1;
4. Positive urine cotinine test at the Screening Visit and Visit Day 1;
5. Electronic cigarettes are the only form of tobacco- or nicotine-containing product used within 30 days of Screening;
6. Willing to use VUSE digital vapor cigarettes during the study according to protocol;
7. 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;
8. 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;
9. Ability to safely perform study procedures, as determined by the Investigator;
10. Group 1-specific inclusion criteria includes the following:

    1. Currently uses VUSE Original digital vapor cigarettes;
    2. Self-reports using VUSE Original digital vapor cigarettes at least once daily, for at least one month prior to the Screening Visit.
11. Group 2-specific inclusion criteria includes the following:

    1. Currently uses VUSE Menthol digital vapor cigarettes;
    2. Self-reports using VUSE Menthol digital vapor cigarettes at least once daily, for at least one month prior to the Screening Visit.

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.

Primary outcomes:
measure: Nicotine pharmacokinetics with respect to initiation of in-clinic investigational product use following a 12-hour tobacco and nicotine abstinence
timeFrame: -5, -0.5, 5, 7.5, 10, 15, 20, 30, 45, 60, 75, 90, 120, 150, 180, 240, 300, 360 minutes
measure: Nicotine pharmacokinetics with respect to initiation of in-clinic investigational product use following a 12-hour tobacco and nicotine abstinence
timeFrame: -5, -0.5, 5, 7.5, 10, 15, 20, 30, 45, 60, 75, 90, 120, 150, 180, 240, 300, 360 minutes
Secondary outcomes:
Other outcomes:
measure: Nicotine pharmacokinetics with respect to initiation of in-clinic investigational product use following a 12-hour tobacco and nicotine abstinence
timeFrame: -5, -0.5, 5, 7.5, 10, 15, 20, 30, 45, 60, 75, 90, 120, 150, 180, 240, 300, 360 minutes
measure: Subjective effects scores for Urge for Product (UFP) with respect to initiation of in-clinic investigational product use following a 12-hour tobacco and nicotine abstinence
timeFrame: -30, 5, 15, 30, 45, 60, 90, 120, 150, 180, 240, 300, 360 minutes
Locations:
city: Lakewood
country: United States
facility: Davita Clinical Reserch
state: Colorado
Study officials:
affiliation: Davita Clinical Research
name: Robert Williams, MD
role: PRINCIPAL_INVESTIGATOR
References: