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

NCT02730676 | Completed

• 1 other identifier: CSD1503
• Study Type: observational
• Target: 44
• Locations: 1 country
• Sites: 1

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.

Conditions

Smoking

Keywords

electronic cigarettes; e-cigarette; combustible cigarette; cigarette; menthol; cig-alike; subjective measures; pharmacokinetics; craving

Outcome Measures

Primary Outcomes (2)

• Nicotine pharmacokinetics with respect to initiation of in-clinic investigational product use following a 12-hour tobacco and nicotine abstinence

  Determine area under the plasma nicotine concentration versus time curve (AUC)

  -5, -0.5, 5, 7.5, 10, 15, 20, 30, 45, 60, 75, 90, 120, 150, 180, 240, 300, 360 minutes

• Nicotine pharmacokinetics with respect to initiation of in-clinic investigational product use following a 12-hour tobacco and nicotine abstinence

  Determine maximum plasma concentration (Cmax), baseline adjusted

  -5, -0.5, 5, 7.5, 10, 15, 20, 30, 45, 60, 75, 90, 120, 150, 180, 240, 300, 360 minutes

Other Outcomes (2)

• Nicotine pharmacokinetics with respect to initiation of in-clinic investigational product use following a 12-hour tobacco and nicotine abstinence

  -5, -0.5, 5, 7.5, 10, 15, 20, 30, 45, 60, 75, 90, 120, 150, 180, 240, 300, 360 minutes

• 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

  -30, 5, 15, 30, 45, 60, 90, 120, 150, 180, 240, 300, 360 minutes

Study Arms (2)

Electronic Cigarette #1

VUSE® Original Digital Vapor Cigarettes (29 mg nicotine)

Other: Electronic Cigarette #1

Electronic Cigarette #2

VUSE® Menthol Digital Vapor Cigarettes (29 mg nicotine)

Other: Electronic Cigarette #2

Interventions

Electronic Cigarette #1 OTHER

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

Also known as: VUSE® Original

Electronic Cigarette #1

Electronic Cigarette #2 OTHER

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

Also known as: VUSE® Menthol

Electronic Cigarette #2

Eligibility Criteria

• Age: 21 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• 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.

You may qualify if:

• 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;
• Ability to safely perform study procedures, as determined by the Investigator;
• Currently uses VUSE Original digital vapor cigarettes;
• Self-reports using VUSE Original digital vapor cigarettes at least once daily, for at least one month prior to the Screening Visit.
• Currently uses VUSE Menthol digital vapor cigarettes;
• Self-reports using VUSE Menthol digital vapor cigarettes at least once daily, for at least one month prior to the Screening Visit.

You may not qualify if:

• 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;
• Self-reports or safety labs indicate diabetes;
• At risk for heart disease, as determined by the Investigator;
• Use of medicine for treatment of depression or asthma;
• Systolic blood pressure of ≥150 mmHg or a diastolic blood pressure of ≥95 mmHg, measured after being seated for 5 minutes;
• Hemoglobin level \<12 g/dL at the Screening Visit;
• Positive test for human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg), or hepatitis C virus antibody (anti-HCV);
• History or presence of hemophilia or other bleeding disorders;
• History or presence of clotting disorders with concomitant use of anticoagulants;
• Given a whole blood donation in the 8 weeks (≤56 days) prior to the Screening Visit;
• Plasma donation within ≤7 days prior to the Screening Visit;
• Body mass index \<18.5 or \>40.0 kg/m2 at the Screening Visit;
• Weight of ≤110 pounds;
• Poor peripheral venous access;
• 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;

Sponsors & Collaborators

• R.J. Reynolds Vapor Company: lead
• Davita Clinical Research: collaborator
• RAI Services Company: collaborator

Study Sites (1)

Davita Clinical Reserch

Lakewood, Colorado, 80228, United States

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Plasma, urine, buccal cells

MeSH Terms

Conditions

Smoking; Vaping

Condition Hierarchy (Ancestors)

Behavior

Study Officials

• Robert Williams, MD

  Davita Clinical Research

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 1, 2016
• First Posted: April 6, 2016
• Study Start: April 1, 2016
• Primary Completion: August 1, 2016
• Study Completion: August 1, 2016
• Last Updated: June 1, 2018

Record last verified: 2018-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)