SmokingNCT02323438
Assess Biomarkers of Tobacco Exposure and Nicotine Pharmacokinetics in Smokers After a 5-Day In-Clinic Confinement Switch to an Electronic Cigarette or Nicotine Gum
A study testing Usual Brand Cigarette, Electronic Cigarette #1 and Electronic Cigarette #2 in people with Smoking, run by R.J. Reynolds Vapor Company at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Smoking
- What is being tested?
- Usual Brand Cigarette, Electronic Cigarette #1 and Electronic Cigarette #2
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 153 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2014to May 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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;
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- 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.
Who cannot join
- 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;
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- 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;
- Employed by a tobacco company, the clinical site, or handles unprocessed tobacco as part of his/her job;
- Use of marijuana-based materials within 30 days prior to screening;
- Use of any medication or supplement that aids smoking cessation, including but not limited to any NRT (eg, nicotine gum, lozenge, patch), varenicline (Chantix®), bupropion (Wellbutrin®, Zyban®), or lobelia extract within 30 days of the Screening Visit;
- Use of injectable forms of medication(s), with the exception of injectable forms of birth control that are not required to be administered during the study period.
- 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);
- Females who have a positive pregnancy test, are pregnant, breastfeeding, or intend to become pregnant during the course of the study;
- Females ≥ 35 years of age currently using systemic, estrogen-containing contraception, or hormone replacement therapy;
- A positive urine drug screen without disclosure of corresponding prescribed concomitant medication(s) at the Screening Visit or Enrollment;
- A positive alcohol breathalyzer test at Screening or Enrollment;
- Regularly exposed to solvent fumes or gasoline (eg, painter, gas station mini-mart employee, etc.);
- Determined by the Investigator to be inappropriate for this study, including a subject who is unable to communicate or unwilling to cooperate with the clinical staff;
- Unable or unwilling to participate in the in-clinic confinement for the full study duration (total of 9 days).
Trial locations and contacts
1 site in 1 country.
United States1 site
DaVita Clinical Research
Minneapolis, Minnesota, 55404
About this study
Official title: A Randomized, Controlled Study to Assess Biomarkers of Tobacco Exposure and Nicotine Pharmacokinetics in Smokers After a 5-Day In-Clinic Confinement Switch to an Electronic Cigarette or Nicotine Gum
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.
- Conditions
- Smoking
- Being tested
- Usual Brand Cigarette, Electronic Cigarette #1, Electronic Cigarette #2, Leading U.S. Nicotine Gum
- Keywords
- biomarkers of tobacco exposure, exposure, tobacco, nicotine, nicotine gum, electronic cigarette, e-cig
- Medical subject headings
- Smoking, Vaping
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Usual Brand CigaretteOther
Also called UB Cigarette
Combustible cigarette brand style smoked most frequently by subject
Electronic Cigarette #1Other
Also called VUSE® Digital Vapor Cigarette (original flavor, 29 mg nicotine)
Electronic cigarette
Electronic Cigarette #2Other
Also called VUSE® Digital Vapor Cigarette (menthol flavor, 26 mg nicotine)
Electronic cigarette
Leading U.S. Nicotine GumOther
4 mg nicotine polacrilex gum
| Study group | Role | What they receive |
|---|---|---|
| Usual Brand (UB) Cigarettes | Active comparator | Usual Brand Cigarette Receives: Other: Usual Brand Cigarette |
| Electronic Cigarette #1 | Experimental | VUSE® (original flavor, 29 mg nicotine) Receives: Other: Electronic Cigarette #1 |
| Electronic Cigarette #2 | Experimental | VUSE® (menthol flavor, 26 mg nicotine) Receives: Other: Electronic Cigarette #2 |
| Leading U.S. Nicotine Gum | Experimental | 4 mg nicotine polacrilex gum Receives: Other: Leading U.S. Nicotine Gum |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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)
Measured: -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
Measured: -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)
Measured: -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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 6 days
Secondary outcomes (1)
Daily product use amounts
Measured: Daily during baseline UB cigarette smoking and each day for 5 days after switch to randomized IP use
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Dec 2014 (estimated)
- Study startDec 2014
- Primary completionMay 2015
- Study completionMay 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SmokingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 153 participants (actual)
Sponsor and investigators
- Lead sponsor
- R.J. Reynolds Vapor Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Davita Clinical Research, RAI Services Company
- Responsible party
- Sponsor
- Investigators
- Harry Alcorn, Jr., PharmD, Principal investigator, Davita Clinical Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02323438
- Sponsor's protocol ID
- CSD1304
- Status last verified
- May 2018
- First submitted
- 18 Dec 2014
- Last updated
- 1 Jun 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Controlled Study to Assess Biomarkers of Tobacco Exposure and Nicotine Pharmacokinetics in Smokers After a 5-Day In-Clinic Confinement Switch to an Electronic Cigarette or Nicotine Gum
- ClinicalTrials.gov ID
- NCT02323438
- Acronym / sponsor ID
- CSD1304
- Conditions
- Smoking
- Keywords
- biomarkers of tobacco exposure, exposure, tobacco, nicotine, nicotine gum, electronic cigarette, e-cig
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 153 participants (actual)
- Lead sponsor
- R.J. Reynolds Vapor CompanyIndustry (pharma, biotech, devices)
- Collaborators
- Davita Clinical Research, RAI Services Company
- Study start
- Dec 2014
- Primary completion
- May 2015 (actual)
- Study completion
- May 2015 (actual)
- First posted
- 23 Dec 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Usual Brand (UB) Cigarettes | Active comparator | Other: Usual Brand CigaretteUsual Brand Cigarette |
| Electronic Cigarette #1 | Experimental | Other: Electronic Cigarette #1VUSE® (original flavor, 29 mg nicotine) |
| Electronic Cigarette #2 | Experimental | Other: Electronic Cigarette #2VUSE® (menthol flavor, 26 mg nicotine) |
| Leading U.S. Nicotine Gum | Experimental | Other: Leading U.S. Nicotine Gum4 mg nicotine polacrilex gum |
Who may qualify
- Ages
- 21 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (13 listed)
- 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;
Key exclusion criteria (27 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Usual Brand CigaretteAlso: UB CigaretteCombustible cigarette brand style smoked most frequently by subject | Other | Usual Brand (UB) Cigarettes |
| Electronic Cigarette #1Also: VUSE® Digital Vapor Cigarette (original flavor, 29 mg nicotine)Electronic cigarette | Other | Electronic Cigarette #1 |
| Electronic Cigarette #2Also: VUSE® Digital Vapor Cigarette (menthol flavor, 26 mg nicotine)Electronic cigarette | Other | Electronic Cigarette #2 |
| Leading U.S. Nicotine Gum4 mg nicotine polacrilex gum | Other | Leading U.S. Nicotine Gum |
Primary outcome
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
Time frame: 6 days
Determine percent change in carboxyhemoglobin (COHb), after 5 days of randomized IP use compared to UB smoking
Nicotine pharmacokinetics with respect to initiation of in-clinic investigational product (IP) use following a 12-hour tobacco and nicotine abstinence
Time frame: -5, -0.5, 3, 5, 7.5, 10, 15, 20, 30, 45, 60, 75, 90, 120, 150, 180, 240, 300, 360 minutes
Determine area under the plasma nicotine concentration versus time curve (AUC)
Nicotine pharmacokinetics with respect to initiation of in-clinic investigational product (IP) use following a 12-hour tobacco and nicotine abstinence
Time frame: -5, -0.5, 3, 5, 7.5, 10, 15, 20, 30, 45, 60, 75, 90, 120, 150, 180, 240, 300, 360 minutes
Determine maximum plasma nicotine concentration (Cmax), baseline adjusted
Nicotine pharmacokinetics with respect to initiation of in-clinic investigational product (IP) use following a 12-hour tobacco and nicotine abstinence
Time frame: -5, -0.5, 3, 5, 7.5, 10, 15, 20, 30, 45, 60, 75, 90, 120, 150, 180, 240, 300, 360 minutes
Determine maximum plasma nicotine concentration (Tmax)
Subjective effects scores for Urge to Smoke (UTS)
Time frame: Three times during baseline UB cigarette smoking and 3 times per day for 5 days after switch to randomized IP use
Determine trends in Urge to Smoke
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
Time frame: 6 days
Determine trends in plasma nicotine and cotinine during randomized IP use compared to UB smoking
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
Time frame: 6 days
Determine percent change in urinary total nicotine equivalents (Nicotine + 10 metabolites), after 5 days of randomized IP use compared to UB smoking
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
Time frame: 6 days
Determine percent change in urinary nitrosamines and metabolites, after 5 days of randomized IP use compared to UB smoking
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
Time frame: 6 days
Determine percent change in urinary 3-aminobiphenyl, after 5 days of randomized IP use compared to UB smoking
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
Time frame: 6 days
Determine percent change in urinary 4-aminobiphenyl, after 5 days of randomized IP use compared to UB smoking
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
Time frame: 6 days
Determine percent change in urinary 1-aminonaphthalene, after 5 days of randomized IP use compared to UB smoking
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
Time frame: 6 days
Determine percent change in urinary 2-aminonaphthalene, after 5 days of randomized IP use compared to UB smoking
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
Time frame: 6 days
Determine percent change in urinary o-toluidine, after 5 days of randomized IP use compared to UB smoking
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
Time frame: 6 days
Determine percent change in urinary S-phenyl mercapturic acid, after 5 days of randomized IP use compared to UB smoking
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
Time frame: 6 days
Determine percent change in urinary 1-hydroxypyrene, after 5 days of randomized IP use compared to UB smoking
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
Time frame: 6 days
Determine percent change in urinary 3-hydroxy-benzo[a]pyrene, after 5 days of randomized IP use compared to UB smoking
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
Time frame: 6 days
Determine percent change in urinary 1-hydroxynapthalene, after 5 days of randomized IP use compared to UB smoking
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
Time frame: 6 days
Determine percent change in urinary 2-hydroxynaphthalene, after 5 days of randomized IP use compared to UB smoking
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
Time frame: 6 days
Determine percent change in urinary 2-hydroxyfluorene, after 5 days of randomized IP use compared to UB smoking
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
Time frame: 6 days
Determine percent change in urinary N-acetyl-S-(3-amino-3-oxypropyl) cysteine, after 5 days of randomized IP use compared to UB smoking
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
Time frame: 6 days
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
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
Time frame: 6 days
Determine percent change in urinary 3-hydroxypropyl mercapturic acid, after 5 days of randomized IP use compared to UB smoking
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
Time frame: 6 days
Determine percent change in urinary 3-hydroxy-1-methylpropyl-mercapturic acid, after 5 days of randomized IP use compared to UB smoking
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
Time frame: 6 days
Determine percent change in urinary monohydroxybutyl mercapturic acid, after 5 days of randomized IP use compared to UB smoking
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
Time frame: 6 days
Determine percent change in urinary 2-cyanoethyl mercapturic acid, after 5 days of randomized IP use compared to UB smoking
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
Time frame: 6 days
Determine percent change in urinary 2-hydroxyethyl mercapturic acid, after 5 days of randomized IP use compared to UB smoking
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
Time frame: 6 days
Determine percent change in urinary thiocyanate, after 5 days of randomized IP use compared to UB smoking
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
Time frame: 6 days
Determine percent change in urinary mutagenicity, after 5 days of randomized IP use compared to UB smoking
1 secondary outcome
Daily product use amounts
Time frame: Daily during baseline UB cigarette smoking and each day for 5 days after switch to randomized IP use
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jun 2018.
- Individual participant dataSharing planned: No
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Smoking Cessation, Lung Cancer Screening
Recruiting
Effectiveness of Volitional Help Sheets as an Adjunct to Treatment to Promote Behavior Change: A Pilot Study on Smoking
Tobacco Dependence
Not yet recruiting
Impacto 2.0: Mobile Smoking Cessation Across Texas
Cigarette Smoking, Smoking Cessation
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Harry Alcorn, Jr., PharmD principal investigator
Davita Clinical Research
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Usual Brand Cigarette, Electronic Cigarette #1 and Electronic Cigarette #2 in people with Smoking, run by R.J. Reynolds Vapor Company at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 27 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Jun 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 (time frame: 6 days). The study lists 28 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jun 2018.