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

NCT ID: NCT02730676

Last Updated: 2018-06-01

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 44 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2016-04-30
• Study Completion Date: 2016-08-31

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.

Conditions

Smoking

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: CROSS_SECTIONAL

Study Groups

Electronic Cigarette #1

VUSE® Original Digital Vapor Cigarettes (29 mg nicotine)

Electronic Cigarette #1

Intervention Type: OTHER

VUSE® Digital Vapor Cigarettes (original flavor, 29 mg nicotine)

Electronic Cigarette #2

VUSE® Menthol Digital Vapor Cigarettes (29 mg nicotine)

Electronic Cigarette #2

Intervention Type: OTHER

VUSE® Digital Vapor Cigarettes (menthol flavor, 29 mg nicotine)

Interventions

Electronic Cigarette #1

VUSE® Digital Vapor Cigarettes (original flavor, 29 mg nicotine)

Intervention Type: OTHER

Electronic Cigarette #2

VUSE® Digital Vapor Cigarettes (menthol flavor, 29 mg nicotine)

Intervention Type: OTHER

Other Intervention Names

VUSE® Original; VUSE® Menthol

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;

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.

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.

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Davita Clinical Research

INDUSTRY

Sponsor Role: collaborator

RAI Services Company

INDUSTRY

Sponsor Role: collaborator

R.J. Reynolds Vapor Company

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Robert Williams, MD

Role: PRINCIPAL_INVESTIGATOR

Davita Clinical Research

Locations

Davita Clinical Reserch

Lakewood, Colorado, United States

Countries

United States

Other Identifiers

CSD1503

Identifier Type: -

Identifier Source: org_study_id