SmokingNCT02269514

Comparison of Nicotine Plasma Concentrations and Subjective Effects for Three Electronic Cigarettes vs Combustible Cigarettes and Nicotine Gum

A study testing Own 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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The purpose of this study is to measure plasma nicotine uptake parameters, physiological measures, and subjective effect measures in smokers during and following a single ad libitum use of three electronic cigarettes versus combustible cigarettes and nicotine gum. 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?: Own Brand Cigarette, Electronic Cigarette #1 and Electronic Cigarette #2
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 45 participants
Where: 1 siteUnited States
Study dates: May 2014to Jan 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 and complete questionnaires written in English.
Generally healthy male or female, 21 to 60 years of age, inclusive, at Screening.
Expired breath carbon monoxide (ECO) level is ≥ 15 ppm and ≤ 100 ppm at the Screening and Randomization Visits, measured between 12 p.m. and 6 p.m.
Cigarettes are the only tobacco product used within (≤) 30 days of Screening.
Smokes combustible, filtered, non-menthol cigarettes, 83 mm to 100 mm in length.
Agrees to smoke usual brand (UB) cigarette throughout the study period. Usual brand cigarette is defined as the cigarette brand style currently smoked most frequently by the subject.

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Smokes at least 10 cigarettes per day (on average) and inhales the smoke, for at least 6 months prior to Screening. Brief periods of abstinence due to illness, quit attempt (prior to 30 days of Screening), or clinical study participation (prior to 30 days of Screening) will be allowed at the discretion of the Investigator.
Response at Screening to Fagerstrom Test for Nicotine Dependence, Question 1 ("How soon after you wake up do you smoke your first cigarette?") is either "Within 5 minutes" or "6 - 30 minutes."
Willing to use UB cigarette, the study electronic cigarette brand styles and nicotine gum during the study period.
Willing to abstain from tobacco and nicotine use for at least 12 hours prior to check-in at each Test Visit.
Willing to not participate for 60 days post-study 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 informed consent until study discharge.

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 (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.
Systolic blood pressure of > 150 mmHg or a diastolic blood pressure of > 95 mmHg at Screening, measured after being seated for at least 5 minutes.
Hemoglobin level is < 12 g/dL at Screening.
Positive test for Human Immunodeficiency Virus (HIV), Hepatitis B surface antigen, or Hepatitis C virus.
Postponing a decision to quit smoking (defined as planning a quit attempt within [≤] 30 days of Screening) to participate in this study or previous attempt within (≤) 30 days prior to Screening.
Employed by a tobacco company, the study site, or handles unprocessed tobacco as part of their job.

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Use of any medication or supplement that aids 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 of Screening.
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 Screening or Randomization Visit. A positive alcohol result at Screening, Randomization Visit, or at any Test Visit.
A female who is pregnant, lactating, or intends to become pregnant during the course of the study.

Trial locations and contacts

1 site in 1 country.

United States1 site

Celerion
Lincoln, Nebraska, 68502

Other trials in United States

About this study

Official title: A Single-Center, Randomized, Open-Label, Crossover Study to Assess Elements of Abuse Liability for Three Electronic Cigarettes

Read the detailed description

This study will assess various elements that may provide information regarding the potential for electronic cigarettes (e-cigarettes) to be adopted by current smokers. These various elements include: a) nicotine pharmacokinetics (PK), b) physiological measures of pulse rate and blood pressure, and c) subjective effects measured by Urge to Smoke, Product Rating, Intent to Use Product Again, and Product Effects.

Conditions: Smoking
Being tested: Own Brand Cigarette, Electronic Cigarette #1, Electronic Cigarette #2, Electronic Cigarette #3, Leading U.S. Nicotine Gum
Keywords: adoption, electronic cigarettes, e-cigarettes, combustible cigarettes, nicotine polacrilex, own brand cigarette, subjective measures, pharmacokinetics, pharmacodynamics
Medical subject headings: Smoking, Vaping

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Own Brand CigaretteOther
combustible cigarette brand style smoked most frequently by subject
Electronic Cigarette #1Other
VUSE® Digital Vapor Cigarette (original flavor, 14mg nicotine)
Electronic Cigarette #2Other
VUSE® Digital Vapor Cigarette (original flavor, 29mg nicotine)
Electronic Cigarette #3Other
VUSE® Digital Vapor Cigarette (original flavor, 36mg nicotine)
Leading U.S. Nicotine GumOther
4 mg nicotine polacrilex gum

Study groups in NCT02269514
Study group	Role	What they receive
Own Brand Cigarette	Active comparator	Own Brand Cigarette Receives: Other: Own Brand Cigarette
Electronic Cigarette #1	Experimental	VUSE® (original flavor, 14mg nicotine) Receives: Other: Electronic Cigarette #1
Electronic Cigarette #2	Experimental	VUSE® (original flavor, 29mg nicotine) Receives: Other: Electronic Cigarette #2
Electronic Cigarette #3	Experimental	VUSE® (original flavor, 36mg nicotine) Receives: Other: Electronic Cigarette #3
Leading U.S. Nicotine Gum	Active comparator	Leading U.S. Nicotine 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.

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 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 IP use following a 12-hour tobacco and nicotine abstinence
Determine time to baseline-adjusted 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) with respect to initiation of in-clinic IP use following a 12-hour tobacco and nicotine abstinence
Score subjective effects using a numeric rating scale (NRS) to determine area under the UTS score-versus-time curve [area under the effect curve (AUEC)], minimum UTS score, and time to minimum UTS score
Measured: -10, 5, 15, 30, 45, 60, 90, 120, 150, 180, 240, 300, 360 minutes
Subjective effects scores for Intent to Use Again (IUA) with respect to initiation of in-clinic IP use following a 12-hour tobacco and nicotine abstinence
Score subjective effects using a NRS to determine area under the IUA score-versus-time curve (AUEC) and maximum IUA score
Measured: 15, 30, 45, 60, 120, 180, 240, 300, 360 minutes
Subjective effects scores for Product Ratings (PR) with respect to initiation of in-clinic IP use following a 12-hour tobacco and nicotine abstinence
Score subjective effects using a NRS to determine area under the PR score-versus-time curve (AUEC) and maximum PR score
Measured: 15, 30, 45, 60, 120, 180, 240, 300, 360 minutes
Subjective effects scores for positive Product Effects (PE) with respect to initiation of in-clinic IP use following a 12-hour tobacco and nicotine abstinence
Score subjective effects using a NRS to determine area under the positive PE score-versus-time curve (AUEC) and maximum positive PE score
Measured: 15, 30, 45, 60, 120, 180, 240, 300, 360 minutes
Subjective effects scores for negative Product Effects (PE) with respect to initiation of in-clinic IP use following a 12-hour tobacco and nicotine abstinence
Score subjective effects using a NRS to determine area under the negative PE score-versus-time curve (AUEC) and maximum negative PE score
Measured: 15, 30, 45, 60, 120, 180, 240, 300, 360 minutes
Maximum change in pulse rate relative to baseline
Determine the maximum change in pulse rate
Measured: Baseline and at timed intervals over 360 minutes following initiation of IP use
Change in expired carbon monoxide (ECO) relative to baseline
Assess change in ECO from baseline following IP use
Measured: Baseline and 35 minutes post-IP use
Baseline cotinine measured pre-IP use
Evaluate changes in baseline cotinine to assess whether subjects substantially changed their nicotine exposure during the study
Measured: -0.5 minute only for each IP, over 5 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

May 2014Jan 2015

First posted21 Oct 2014 (estimated)
Study startMay 2014
Primary completionJan 2015
Study completionJan 2015

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (1)Papers the sponsor has linked to this study.
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: Other
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Enrolment: 45 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02269514
Sponsor's protocol ID: CSD1303
Status last verified: May 2018
First submitted: 26 Sep 2014
Last updated: 4 Jun 2018
Results posted: No
Data monitoring committee: No
Individual data sharing: No

Publications

Stiles MF, Campbell LR, Graff DW, Jones BA, Fant RV, Henningfield JE. Pharmacodynamic and pharmacokinetic assessment of electronic cigarettes, combustible cigarettes, and nicotine gum: implications for abuse liability. Psychopharmacology (Berl). 2017 Sep;234(17):2643-2655. doi: 10.1007/s00213-017-4665-y. Epub 2017 Jun 20.
PubMed 28634710

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 4 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Single-Center, Randomized, Open-Label, Crossover Study to Assess Elements of Abuse Liability for Three Electronic Cigarettes
ClinicalTrials.gov ID: NCT02269514
Acronym / sponsor ID: CSD1303
Conditions: Smoking
Keywords: adoption, electronic cigarettes, e-cigarettes, combustible cigarettes, nicotine polacrilex, own brand cigarette, subjective measures, pharmacokinetics
Study type: Interventional
Recruitment status: Completed
Enrolment: 45 participants (actual)
Lead sponsor: R.J. Reynolds Vapor CompanyIndustry (pharma, biotech, devices)
Collaborators: Celerion, RAI Services Company
Study start: May 2014
Primary completion: Jan 2015 (actual)
Study completion: Jan 2015 (actual)
First posted: 21 Oct 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.

Detailed description

Study design

Primary purpose: Other
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Number of arms: 5

Arm	Type	Receives
Own Brand Cigarette	Active comparator	Other: Own Brand CigaretteOwn Brand Cigarette
Electronic Cigarette #1	Experimental	Other: Electronic Cigarette #1VUSE® (original flavor, 14mg nicotine)
Electronic Cigarette #2	Experimental	Other: Electronic Cigarette #2VUSE® (original flavor, 29mg nicotine)
Electronic Cigarette #3	Experimental	Other: Electronic Cigarette #3VUSE® (original flavor, 36mg nicotine)
Leading U.S. Nicotine Gum	Active comparator	Other: Leading U.S. Nicotine GumLeading U.S. Nicotine Gum

Who may qualify

Ages: 21 to 60 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (12 listed)

Able to read, understand, and willing to sign an informed consent form and complete questionnaires written in English.
Generally healthy male or female, 21 to 60 years of age, inclusive, at Screening.
Expired breath carbon monoxide (ECO) level is ≥ 15 ppm and ≤ 100 ppm at the Screening and Randomization Visits, measured between 12 p.m. and 6 p.m.
Cigarettes are the only tobacco product used within (≤) 30 days of Screening.
Smokes combustible, filtered, non-menthol cigarettes, 83 mm to 100 mm in length.

Key exclusion criteria (10 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 (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.
Systolic blood pressure of > 150 mmHg or a diastolic blood pressure of > 95 mmHg at Screening, measured after being seated for at least 5 minutes.
Hemoglobin level is < 12 g/dL at Screening.
Positive test for Human Immunodeficiency Virus (HIV), Hepatitis B surface antigen, or Hepatitis C virus.
Postponing a decision to quit smoking (defined as planning a quit attempt within [≤] 30 days of Screening) to participate in this study or previous attempt within (≤) 30 days prior to Screening.

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
Own Brand Cigarettecombustible cigarette brand style smoked most frequently by subject	Other	Own Brand Cigarette
Electronic Cigarette #1VUSE® Digital Vapor Cigarette (original flavor, 14mg nicotine)	Other	Electronic Cigarette #1
Electronic Cigarette #2VUSE® Digital Vapor Cigarette (original flavor, 29mg nicotine)	Other	Electronic Cigarette #2
Electronic Cigarette #3VUSE® Digital Vapor Cigarette (original flavor, 36mg nicotine)	Other	Electronic Cigarette #3
Leading U.S. Nicotine Gum4 mg nicotine polacrilex gum	Other	Leading U.S. Nicotine Gum

Primary outcome

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 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 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 time to baseline-adjusted maximum plasma nicotine concentration (Tmax)
Subjective effects scores for Urge to Smoke (UTS) with respect to initiation of in-clinic IP use following a 12-hour tobacco and nicotine abstinence
Time frame: -10, 5, 15, 30, 45, 60, 90, 120, 150, 180, 240, 300, 360 minutes
Score subjective effects using a numeric rating scale (NRS) to determine area under the UTS score-versus-time curve [area under the effect curve (AUEC)], minimum UTS score, and time to minimum UTS score
Subjective effects scores for Intent to Use Again (IUA) with respect to initiation of in-clinic IP use following a 12-hour tobacco and nicotine abstinence
Time frame: 15, 30, 45, 60, 120, 180, 240, 300, 360 minutes
Score subjective effects using a NRS to determine area under the IUA score-versus-time curve (AUEC) and maximum IUA score
Subjective effects scores for Product Ratings (PR) with respect to initiation of in-clinic IP use following a 12-hour tobacco and nicotine abstinence
Time frame: 15, 30, 45, 60, 120, 180, 240, 300, 360 minutes
Score subjective effects using a NRS to determine area under the PR score-versus-time curve (AUEC) and maximum PR score
Subjective effects scores for positive Product Effects (PE) with respect to initiation of in-clinic IP use following a 12-hour tobacco and nicotine abstinence
Time frame: 15, 30, 45, 60, 120, 180, 240, 300, 360 minutes
Score subjective effects using a NRS to determine area under the positive PE score-versus-time curve (AUEC) and maximum positive PE score
Subjective effects scores for negative Product Effects (PE) with respect to initiation of in-clinic IP use following a 12-hour tobacco and nicotine abstinence
Time frame: 15, 30, 45, 60, 120, 180, 240, 300, 360 minutes
Score subjective effects using a NRS to determine area under the negative PE score-versus-time curve (AUEC) and maximum negative PE score
Maximum change in pulse rate relative to baseline
Time frame: Baseline and at timed intervals over 360 minutes following initiation of IP use
Determine the maximum change in pulse rate
Change in expired carbon monoxide (ECO) relative to baseline
Time frame: Baseline and 35 minutes post-IP use
Assess change in ECO from baseline following IP use
Baseline cotinine measured pre-IP use
Time frame: -0.5 minute only for each IP, over 5 weeks
Evaluate changes in baseline cotinine to assess whether subjects substantially changed their nicotine exposure during the study

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 4 Jun 2018.
Results publication: PubMed 28634710Stiles MF, Campbell LR, Graff DW, Jones BA, Fant RV, Henningfield JE. Pharmacodynamic and pharmacokinetic assessment of electronic cigarettes, combustible cigarettes, and nicotine gum: implications for abuse liability. Psychopharmacology (Berl). 2017 Sep;234(17):2643-2655. doi: 10.1007/s00213-017-4665-y. Epub 2017 Jun 20.
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.

Michael Gartner, MD principal investigator

Celerion

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Own 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 12 inclusion and 10 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 4 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 (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). The study lists 11 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02269514, which also lists 1 linked publication.

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 4 Jun 2018.