NCT02323438

Brief Summary

A single-center, randomized, controlled, switching, open-label, parallel cohort study. Smoking subjects will be confined to a clinic for 9 days. During their stay, baseline assessments during ad libitum smoking will occur for the first 3 days. Following baseline, subjects will be switched to either an Electronic Cigarette or Nicotine Gum, and post-product switch assessments will occur for 6 days.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
153

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Dec 2014

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2014

Completed
17 days until next milestone

First Submitted

Initial submission to the registry

December 18, 2014

Completed
5 days until next milestone

First Posted

Study publicly available on registry

December 23, 2014

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2015

Completed
Last Updated

June 1, 2018

Status Verified

May 1, 2018

Enrollment Period

5 months

First QC Date

December 18, 2014

Last Update Submit

May 31, 2018

Conditions

Smoking

Keywords

biomarkers of tobacco exposureexposuretobacconicotinenicotine gumelectronic cigarettee-cig

Outcome Measures

Primary Outcomes (28)

  • Changes in biomarkers of tobacco exposure after a 5-day, in-clinic switch from usual brand (UB) cigarettes to an Electronic Cigarette or Nicotine Gum

    Determine percent change in carboxyhemoglobin (COHb), after 5 days of randomized IP use compared to UB smoking

    6 days

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

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

    -5, -0.5, 3, 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 (IP) use following a 12-hour tobacco and nicotine abstinence

    Determine maximum plasma nicotine concentration (Cmax), baseline adjusted

    -5, -0.5, 3, 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 (IP) use following a 12-hour tobacco and nicotine abstinence

    Determine maximum plasma nicotine concentration (Tmax)

    -5, -0.5, 3, 5, 7.5, 10, 15, 20, 30, 45, 60, 75, 90, 120, 150, 180, 240, 300, 360 minutes

  • Subjective effects scores for Urge to Smoke (UTS)

    Determine trends in Urge to Smoke

    Three times during baseline UB cigarette smoking and 3 times per day for 5 days after switch to randomized IP use

  • Changes in biomarkers of tobacco exposure after a 5-day, in-clinic switch from usual brand (UB) cigarettes to an Electronic Cigarette or Nicotine Gum

    Determine trends in plasma nicotine and cotinine during randomized IP use compared to UB smoking

    6 days

  • Changes in biomarkers of tobacco exposure after a 5-day, in-clinic switch from usual brand (UB) cigarettes to an Electronic Cigarette or Nicotine Gum

    Determine percent change in urinary total nicotine equivalents (Nicotine + 10 metabolites), after 5 days of randomized IP use compared to UB smoking

    6 days

  • Changes in biomarkers of tobacco exposure after a 5-day, in-clinic switch from usual brand (UB) cigarettes to an Electronic Cigarette or Nicotine Gum

    Determine percent change in urinary nitrosamines and metabolites, after 5 days of randomized IP use compared to UB smoking

    6 days

  • Changes in biomarkers of tobacco exposure after a 5-day, in-clinic switch from usual brand (UB) cigarettes to an Electronic Cigarette or Nicotine Gum

    Determine percent change in urinary 3-aminobiphenyl, after 5 days of randomized IP use compared to UB smoking

    6 days

  • Changes in biomarkers of tobacco exposure after a 5-day, in-clinic switch from usual brand (UB) cigarettes to an Electronic Cigarette or Nicotine Gum

    Determine percent change in urinary 4-aminobiphenyl, after 5 days of randomized IP use compared to UB smoking

    6 days

  • Changes in biomarkers of tobacco exposure after a 5-day, in-clinic switch from usual brand (UB) cigarettes to an Electronic Cigarette or Nicotine Gum

    Determine percent change in urinary 1-aminonaphthalene, after 5 days of randomized IP use compared to UB smoking

    6 days

  • Changes in biomarkers of tobacco exposure after a 5-day, in-clinic switch from usual brand (UB) cigarettes to an Electronic Cigarette or Nicotine Gum

    Determine percent change in urinary 2-aminonaphthalene, after 5 days of randomized IP use compared to UB smoking

    6 days

  • Changes in biomarkers of tobacco exposure after a 5-day, in-clinic switch from usual brand (UB) cigarettes to an Electronic Cigarette or Nicotine Gum

    Determine percent change in urinary o-toluidine, after 5 days of randomized IP use compared to UB smoking

    6 days

  • Changes in biomarkers of tobacco exposure after a 5-day, in-clinic switch from usual brand (UB) cigarettes to an Electronic Cigarette or Nicotine Gum

    Determine percent change in urinary S-phenyl mercapturic acid, after 5 days of randomized IP use compared to UB smoking

    6 days

  • Changes in biomarkers of tobacco exposure after a 5-day, in-clinic switch from usual brand (UB) cigarettes to an Electronic Cigarette or Nicotine Gum

    Determine percent change in urinary 1-hydroxypyrene, after 5 days of randomized IP use compared to UB smoking

    6 days

  • Changes in biomarkers of tobacco exposure after a 5-day, in-clinic switch from usual brand (UB) cigarettes to an Electronic Cigarette or Nicotine Gum

    Determine percent change in urinary 3-hydroxy-benzo\[a\]pyrene, after 5 days of randomized IP use compared to UB smoking

    6 days

  • Changes in biomarkers of tobacco exposure after a 5-day, in-clinic switch from usual brand (UB) cigarettes to an Electronic Cigarette or Nicotine Gum

    Determine percent change in urinary 1-hydroxynapthalene, after 5 days of randomized IP use compared to UB smoking

    6 days

  • Changes in biomarkers of tobacco exposure after a 5-day, in-clinic switch from usual brand (UB) cigarettes to an Electronic Cigarette or Nicotine Gum

    Determine percent change in urinary 2-hydroxynaphthalene, after 5 days of randomized IP use compared to UB smoking

    6 days

  • Changes in biomarkers of tobacco exposure after a 5-day, in-clinic switch from usual brand (UB) cigarettes to an Electronic Cigarette or Nicotine Gum

    Determine percent change in urinary 2-hydroxyfluorene, after 5 days of randomized IP use compared to UB smoking

    6 days

  • Changes in biomarkers of tobacco exposure after a 5-day, in-clinic switch from usual brand (UB) cigarettes to an Electronic Cigarette or Nicotine Gum

    Determine percent change in urinary N-acetyl-S-(3-amino-3-oxypropyl) cysteine, after 5 days of randomized IP use compared to UB smoking

    6 days

  • Changes in biomarkers of tobacco exposure after a 5-day, in-clinic switch from usual brand (UB) cigarettes to an Electronic Cigarette or Nicotine Gum

    Determine percent change in urinary N-acetyl-S-(3-amino-2-hydroxy-3-oxopropyl) cysteine, after 5 days of randomized IP use compared to UB smoking

    6 days

  • Changes in biomarkers of tobacco exposure after a 5-day, in-clinic switch from usual brand (UB) cigarettes to an Electronic Cigarette or Nicotine Gum

    Determine percent change in urinary 3-hydroxypropyl mercapturic acid, after 5 days of randomized IP use compared to UB smoking

    6 days

  • Changes in biomarkers of tobacco exposure after a 5-day, in-clinic switch from usual brand (UB) cigarettes to an Electronic Cigarette or Nicotine Gum

    Determine percent change in urinary 3-hydroxy-1-methylpropyl-mercapturic acid, after 5 days of randomized IP use compared to UB smoking

    6 days

  • Changes in biomarkers of tobacco exposure after a 5-day, in-clinic switch from usual brand (UB) cigarettes to an Electronic Cigarette or Nicotine Gum

    Determine percent change in urinary monohydroxybutyl mercapturic acid, after 5 days of randomized IP use compared to UB smoking

    6 days

  • Changes in biomarkers of tobacco exposure after a 5-day, in-clinic switch from usual brand (UB) cigarettes to an Electronic Cigarette or Nicotine Gum

    Determine percent change in urinary 2-cyanoethyl mercapturic acid, after 5 days of randomized IP use compared to UB smoking

    6 days

  • Changes in biomarkers of tobacco exposure after a 5-day, in-clinic switch from usual brand (UB) cigarettes to an Electronic Cigarette or Nicotine Gum

    Determine percent change in urinary 2-hydroxyethyl mercapturic acid, after 5 days of randomized IP use compared to UB smoking

    6 days

  • Changes in biomarkers of tobacco exposure after a 5-day, in-clinic switch from usual brand (UB) cigarettes to an Electronic Cigarette or Nicotine Gum

    Determine percent change in urinary thiocyanate, after 5 days of randomized IP use compared to UB smoking

    6 days

  • Changes in biomarkers of tobacco exposure after a 5-day, in-clinic switch from usual brand (UB) cigarettes to an Electronic Cigarette or Nicotine Gum

    Determine percent change in urinary mutagenicity, after 5 days of randomized IP use compared to UB smoking

    6 days

Secondary Outcomes (1)

  • Daily product use amounts

    Daily during baseline UB cigarette smoking and each day for 5 days after switch to randomized IP use

Study Arms (4)

Usual Brand (UB) Cigarettes

ACTIVE COMPARATOR

Usual Brand Cigarette

Other: Usual Brand Cigarette

Electronic Cigarette #1

EXPERIMENTAL

VUSE® (original flavor, 29 mg nicotine)

Other: Electronic Cigarette #1

Electronic Cigarette #2

EXPERIMENTAL

VUSE® (menthol flavor, 26 mg nicotine)

Other: Electronic Cigarette #2

Leading U.S. Nicotine Gum

EXPERIMENTAL

4 mg nicotine polacrilex gum

Other: Leading U.S. Nicotine Gum

Interventions

Usual Brand CigaretteOTHER

Combustible cigarette brand style smoked most frequently by subject

Also known as: UB Cigarette
Usual Brand (UB) Cigarettes
Electronic Cigarette #1OTHER

Electronic cigarette

Also known as: VUSE® Digital Vapor Cigarette (original flavor, 29 mg nicotine)
Electronic Cigarette #1
Electronic Cigarette #2OTHER

Electronic cigarette

Also known as: VUSE® Digital Vapor Cigarette (menthol flavor, 26 mg nicotine)
Electronic Cigarette #2
Leading U.S. Nicotine GumOTHER

4 mg nicotine polacrilex gum

Leading U.S. Nicotine Gum

Eligibility Criteria

Age21 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

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 or females, 21 to 60 years of age (inclusive);
  • Screening expired-air carbon monoxide (ECO) level ≥ 15 parts per million (ppm; sample taken 30 to 60 minutes after smoking a single UB cigarette);
  • Currently smokes combustible, filtered, nonmenthol or menthol cigarettes, 83 mm to 100 mm length;
  • Self-reports that cigarettes are the only tobacco or nicotine-containing product used within 30 days of the Screening Visit;
  • Self-reports at the Screening Visit smoking at least 10 cigarettes per day and inhaling the smoke for at least 6 months prior to the Screening Visit;
  • Response to Fagerström Test for Nicotine Dependence (FTND) Question 1 ("How soon after you wake up do you smoke your first cigarette?") is either "Within 5 minutes" or "6-30 minutes" at the Screening Visit;
  • Positive urine cotinine test at Screening and Enrollment;
  • Willing to switch from current cigarette to VUSE Digital Vapor Cigarettes or nicotine gum for 6 days during in-clinic confinement (nonmenthol smokers willing to switch to VUSE Original Digital Vapor Cigarettes or nicotine gum; menthol smokers willing to switch to VUSE Menthol Digital Vapor Cigarettes or nicotine gum);
  • Willing to abstain from tobacco and nicotine use for at least 12 hours twice during confinement;
  • Willing to not participate for 60 days poststudy in donation of blood samples or in any study that requires collection of blood samples;
  • Females of childbearing potential 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;
  • Able to safely perform the required study procedures, as determined by the Investigator.

You may not qualify if:

  • Clinically significant or unstable/uncontrolled acute or chronic medical conditions at screening, as determined by the Investigator, that would preclude a subject from participating safely in the study (eg, hypertension, asthma, or other lung disease, cardiac disease, neurological disease, or psychiatric disorders) based on screening assessments such as safety labs, medical history, and physical/oral examinations;
  • Self-reports or safety labs indicate diabetes;
  • Self-reports stomach ulcers;
  • 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;
  • Positive test for human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg), or hepatitis C virus antibody (anti-HCV);
  • Hemoglobin level is \< 12 g/dL at Screening:
  • History or presence of hemophilia or any other bleeding disorders:
  • History or presence of clotting disorders with concomitant use of anticoagulants (eg, clopidogrel \[Plavix®\], warfarin \[Coumadin®, Jantoven®\], and aspirin \[\> 325 mg/day\]);
  • Given a whole blood donation within 8 weeks (≤ 56 days) prior to Enrollment;
  • Plasma donation within (≤) 7 days prior to Enrollment;
  • Weight of ≤ 110 pounds;
  • Poor peripheral venous access;
  • Postponing a decision to quit smoking (defined as planning a quit attempt within 30 days of Screening) to participate in this study;
  • +12 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

DaVita Clinical Research

Minneapolis, Minnesota, 55404, United States

Location

MeSH Terms

Conditions

SmokingVaping

Interventions

NicotineMenthol

Condition Hierarchy (Ancestors)

Behavior

Intervention Hierarchy (Ancestors)

Solanaceous AlkaloidsAlkaloidsHeterocyclic CompoundsPyridinesHeterocyclic Compounds, 1-RingCyclohexanolsHexanolsFatty AlcoholsAlcoholsOrganic ChemicalsCyclohexane MonoterpenesCyclohexanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicHydrocarbonsMonoterpenesTerpenesLipids

Study Officials

  • Harry Alcorn, Jr., PharmD

    Davita Clinical Research

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 18, 2014

First Posted

December 23, 2014

Study Start

December 1, 2014

Primary Completion

May 1, 2015

Study Completion

May 1, 2015

Last Updated

June 1, 2018

Record last verified: 2018-05

Data Sharing

IPD Sharing
Will not share

Locations

US(1)