SmokingNCT02730676
Comparison of Pharmacokinetic Parameters Between Adopters of Electronic Cigarettes and a Historical Sample of Combustible Cigarette Smokers
An observational study of Smoking, run by R.J. Reynolds Vapor Company at 1 site in United States.
Trial 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… 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?
- Electronic Cigarette #1 and Electronic Cigarette #2
- How many people
- 44 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2016to Aug 2016
- Phase
- Observational
- 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
Study population: Generally healthy males and females 21 to 60 years of age who are exclusive users of electronic cigarettes.
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 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;
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- 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;
- Group 1-specific inclusion criteria includes the following:
- 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.
- Group 2-specific inclusion criteria includes the following:
- 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.
Who cannot join
- 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;
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- 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;
- 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;
- Females who test positive for pregnancy, are pregnant or breastfeeding, or plan to become pregnant during the course of the study;
- A positive urine drug screen without disclosure of corresponding concomitant medication(s) at the Screening Visit or on Visit Day 1;
- A positive alcohol breathalyzer result at Screening or on Visit Day 1;
- 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);
- 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;
- Employed by a tobacco or nicotine company, the study site, or handled tobacco or nicotine products as part of your job.
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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
- Being tested
- Electronic Cigarette #1, Electronic Cigarette #2
- Keywords
- electronic cigarettes, e-cigarette, combustible cigarette, cigarette, menthol, cig-alike, subjective measures, pharmacokinetics, craving
- Medical subject headings
- Smoking, Vaping
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Electronic Cigarette #1Other
Also called VUSE® Original
VUSE® Digital Vapor Cigarettes (original flavor, 29 mg nicotine)
Electronic Cigarette #2Other
Also called VUSE® Menthol
VUSE® Digital Vapor Cigarettes (menthol flavor, 29 mg nicotine)
| Study group | Role | What they receive |
|---|---|---|
| Electronic Cigarette #1 | VUSE® Original Digital Vapor Cigarettes (29 mg nicotine) Receives: Other: Electronic Cigarette #1 | |
| Electronic Cigarette #2 | VUSE® Menthol Digital Vapor Cigarettes (29 mg nicotine) Receives: Other: Electronic Cigarette #2 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: -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
Measured: -5, -0.5, 5, 7.5, 10, 15, 20, 30, 45, 60, 75, 90, 120, 150, 180, 240, 300, 360 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2016 (estimated)
- Study startApr 2016
- Primary completionAug 2016
- Study completionAug 2016
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
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 44 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
- Robert Williams, MD, Principal investigator, Davita Clinical Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02730676
- Sponsor's protocol ID
- CSD1503
- Status last verified
- May 2018
- First submitted
- 1 Apr 2016
- 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 Study to Assess Nicotine Pharmacokinetic Parameters of Digital Vapor Cigarettes in Adopters and Compare Them to Nicotine Pharmacokinetic Parameters of Cigarettes in Smokers
- ClinicalTrials.gov ID
- NCT02730676
- Acronym / sponsor ID
- CSD1503
- Conditions
- Smoking
- Keywords
- electronic cigarettes, e-cigarette, combustible cigarette, cigarette, menthol, cig-alike, subjective measures, pharmacokinetics
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- R.J. Reynolds Vapor CompanyIndustry (pharma, biotech, devices)
- Collaborators
- Davita Clinical Research, RAI Services Company
- Study start
- Apr 2016
- Primary completion
- Aug 2016 (actual)
- Study completion
- Aug 2016 (actual)
- First posted
- 6 Apr 2016 (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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Electronic Cigarette #1 | – | Other: Electronic Cigarette #1VUSE® Original Digital Vapor Cigarettes (29 mg nicotine) |
| Electronic Cigarette #2 | – | Other: Electronic Cigarette #2VUSE® Menthol Digital Vapor Cigarettes (29 mg nicotine) |
Who may qualify
- Ages
- 21 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Generally healthy males and females 21 to 60 years of age who are exclusive users of electronic cigarettes.
Key inclusion criteria (15 listed)
- 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;
Key exclusion criteria (22 listed)
- 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;
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 |
|---|---|---|
| Electronic Cigarette #1Also: VUSE® OriginalVUSE® Digital Vapor Cigarettes (original flavor, 29 mg nicotine) | Other | Electronic Cigarette #1 |
| Electronic Cigarette #2Also: VUSE® MentholVUSE® Digital Vapor Cigarettes (menthol flavor, 29 mg nicotine) | Other | Electronic Cigarette #2 |
Primary outcome
Nicotine pharmacokinetics with respect to initiation of in-clinic investigational product use following a 12-hour tobacco and nicotine abstinence
Time frame: -5, -0.5, 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 use following a 12-hour tobacco and nicotine abstinence
Time frame: -5, -0.5, 5, 7.5, 10, 15, 20, 30, 45, 60, 75, 90, 120, 150, 180, 240, 300, 360 minutes
Determine maximum plasma concentration (Cmax), baseline adjusted
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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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.
Robert Williams, MD 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?
An observational study of 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 15 inclusion and 22 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?
Nicotine pharmacokinetics with respect to initiation of in-clinic investigational product use following a 12-hour tobacco and nicotine abstinence (time frame: -5, -0.5, 5, 7.5, 10, 15, 20, 30, 45, 60, 75, 90, 120, 150, 180, 240, 300, 360 minutes). The study lists 2 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.