Healthy VolunteersNCT03178981
E-cigarette Nicotine Pharmacokinetic Study
A study testing Use electronic cigarette or smoke conventional cigarette in people with Healthy Volunteers and Smoking, run by British American Tobacco (Investments) Limited at 1 site in United States.
Trial summary
This study will compare nicotine delivery and product satisfaction in healthy subjects either using several different types of electronic cigarettes or smoking a conventional cigarette. Read more about this study
- Who is it for?
- Ages 22 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers, Smoking
- What is being tested?
- Use electronic cigarette or smoke conventional cigarette
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteUnited States
- Study dates
- 26 Jun 2017to 8 Sep 2017
- 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 22 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Prior to study start, subjects must be current smokers of conventional factory-made cigarettes (eCO >10ppm at screening) who have either tried or are occasional users of e-cigarettes. Subjects must be smoking ≥10 cigarettes per day and must have done so for at least one year. Smoking status will be confirmed with a urinary cotinine level of ≥200ng/ml (determined using NicAlert cotinine test kit) and an exhaled breath CO level of >10ppm (determined using a Smokerlyzer breath CO monitor) at screening, as well as by tobacco use questionnaire.
- Subjects will be males or non-pregnant, non-lactating females, and between 22 and 55 years of age inclusive. Age verification will be performed by checking of Federal or state-issued ID (eg. passport or driving licence) during screening.
- Women of child-bearing potential should be using one of the following acceptable methods of contraception : combined (oestrogen and progestogen containing) oral, intravaginal or transdermal hormonal contraception associated with inhibition of ovulation; progestogen-only hormonal contraception, either oral, injected or implanted, associated with inhibition of ovulation; progestogen-only oral hormonal contraception where inhibition of ovulation is not the primary mode of action; intrauterine device (IUD); intrauterine hormone-releasing system (IUS); bilateral tubal occlusion; male or female condom with or without spermicide; cap, diaphragm or sponge with spermicide.
- Women of non-childbearing potential may be included if they are either surgically sterile (hysterectomy and/or oophorectomy) or postmenopausal for more than 1 year and must have a negative urine pregnancy test result during screening. Women who are surgically sterile must provide documentation of the procedure by an operative report.
- Male subjects must use an approved method of birth control during the entire study. These subjects must not donate sperm during this time.
- Subjects must be in good health, as judged by the PI or the appropriately qualified designee based on medical history, ECG, vital signs, blood biochemistry, haematology, urinalysis and physical examination.
Show all 12Show fewer
- Subjects must have a body mass index (BMI) between 18 and 30 kg/m2 inclusive. Male subjects must have a weight between 60 and 120kg and female subjects between 50 and 100kg.
- No clinically significant abnormalities in blood pressure values.
- Subjects will have negative results for the urinary drug of abuse screening and alcohol test.
- Subjects will have given their written informed consent to participate in the study and to abide by the study restrictions.
- To be confirmed during each clinic visit:
- 1. Abstinence from tobacco and nicotine products will be confirmed by an exhaled breath CO reading <15ppm.
Who cannot join
- Subjects who have a history of, or clinically active significant, neurological, gastrointestinal, renal, hepatic, cardiovascular, psychiatric, respiratory, metabolic, endocrine, haematological disease or other major disorders.
- Subjects who have any clinically significant abnormal laboratory safety findings at Screening and prior to first product use, as determined by the PI or the appropriately qualified designee (1 repeat assessment is acceptable).
- Subjects who have previously been diagnosed with any form of malignancy.
- Subjects with significant allergies who in the opinion of the Principal Investigator or appropriately qualified designee should not be included.
- Subjects who have had an acute illness (e.g. upper respiratory tract infection, viral infection, etc.) requiring treatment within 4 weeks prior to Admission.
- Subjects who have used prescription or over-the-counter (OTC) bronchodilator medication (e.g. inhaled or oral β-adrenergic agonists) to treat a chronic condition within the 12 months prior to Admission.
Show all 22Show fewer
- Subjects with a recent history of or current drug or alcohol abuse who in the opinion of the Investigator should not be included. Excessive intake of alcohol within the last 6 months, defined as a regular maximum weekly intake of greater than 7 drinks for women or 14 drinks for men. One drink is defined as one pint of regular beer (5% alcohol), 200 ml of wine (12% alcohol), or 25 ml of distilled spirits (40% alcohol).
- Subjects with an inability to communicate well with the Investigator/study staff (i.e., language problem, poor mental development or impaired cerebral function).
- Subjects who are participating in another clinical research study or who have participated in a clinical research study in the last 2 months.
- Subjects who have had treatment with prescription medications within 21 days or over-the-counter medication within 24 hours of the planned first product use occasion, except for those stated in the Inclusion Criteria. For all subjects, prescribed use of blood pressure (beta blockers) and lipid lowering (statin) medications are permitted.
- Subjects who have used any drugs or substances (except tobacco) known to be strong inducers or inhibitors of any CYP enzymes (formerly known as cytochrome P450 enzymes) within a 28 days period prior to first product administration. For a list of such drugs and substances, please refer to http://medicine.iupui.edu/clinpharm/ddis/main-table/.
- Subjects who have had any treatment with smoking cessation medications (e.g. Bupropion, Chantix or any NRT) within 30 days of the planned first product use occasion.
- Subjects with any other clinically significant medical history, in the Investigator's opinion, including conditions which might affect drug absorption, metabolism or excretion.
- Female subjects, who are pregnant or become pregnant during the course of the study.
- Subjects who have lost or donated more than 450ml of blood within the 2 months preceding the first product administration.
- Subjects who are self-reported non-inhalers (smokers who draw smoke from the cigarette into the mouth and throat but who do not inhale). Subjects who are observed as non-inhalers at Admission by the clinic staff will be excluded.
- Subjects who are currently trying to stop smoking or to stop using e-cigarettes, or considering stopping in the next two months. All subjects will be informed that they are free to quit smoking/using e-cigarettes and withdraw from the study at any time.
- Subjects who are unwilling or unable to comply with the study requirements.
- Subjects who in the opinion of the Principal Investigator or their appropriately qualified designee should not participate in the study for any other reason.
- To be re-confirmed during each clinic visit:
- Subject continues to meet all screening exclusion criteria. Pregnancy test to be performed on all female subjects at each visit.
- Receipt of any medication since screening visit that may have an impact on the safety and objectives of the study (at the Principal Investigator's discretion).
Trial locations and contacts
1 site in 1 country.
United States1 site
Los Angeles Clinical Trials
Burbank, California, 91505
About this study
Official title: A Pharmacokinetic Study to Examine Nicotine Delivery From E-cigarettes and a Conventional Cigarette in Healthy Subjects During a Brief Period of ad Libitum Use
This study will compare nicotine delivery and product satisfaction in healthy subjects either using several different types of electronic cigarettes or smoking a conventional cigarette.
- Conditions
- Healthy Volunteers, Smoking
- Being tested
- Use electronic cigarette or smoke conventional cigarette
- Medical subject headings
- Smoking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Use electronic cigarette or smoke conventional cigaretteOther
Use of electronic cigarette or smoking conventional cigarette ad libitum for 5 minute period
| Study group | Role | What they receive |
|---|---|---|
| Conventional cigarette | Active comparator | Commercially-available combustible cigarette Receives: Other: Use electronic cigarette or smoke conventional cigarette |
| Second-generation e-cigarette A | Experimental | Prototype second-generation (closed-tank) e-cigarette Receives: Other: Use electronic cigarette or smoke conventional cigarette |
| Second-generation e-cigarette B | Experimental | Prototype second-generation (closed-tank) e-cigarette Receives: Other: Use electronic cigarette or smoke conventional cigarette |
| Second-generation e-cigarette C | Experimental | Prototype second-generation (closed-tank) e-cigarette Receives: Other: Use electronic cigarette or smoke conventional cigarette |
| Second-generation e-cigarette D | Experimental | Prototype second-generation (closed-tank) e-cigarette Receives: Other: Use electronic cigarette or smoke conventional cigarette |
| Second-generation e-cigarette E | Active comparator | Commercially-available second-generation (closed-tank) e-cigarette Receives: Other: Use electronic cigarette or smoke conventional cigarette |
What is being measured
The primary outcome is the main question the study is designed to answer.
Plasma nicotine concentration (Cmax)
Nicotine pharmacokinetics
Measured: -5, 1, 3, 5, 6, 7, 9, 15, 45, and 60 minutes relative to the first puff on the cigarette/e-cigarette
Plasma nicotine concentration (Tmax)
Nicotine pharmacokinetics
Measured: -5, 1, 3, 5, 6, 7, 9, 15, 45, and 60 minutes relative to the first puff on the cigarette/e-cigarette
Plasma nicotine concentration (AUC0-60)
Nicotine pharmacokinetics
Measured: -5, 1, 3, 5, 6, 7, 9, 15, 45, and 60 minutes relative to the first puff on the cigarette/e-cigarette
Secondary outcomes (3)
Number of puffs taken
Measured: During 5 minute ad libitum puffing period
Subjective measurement of product satisfaction
Measured: After 60 minute blood sampling period
Mass loss from e-cigarette cartridge during puffing
Measured: During 5 minute ad libitum puffing period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jun 2017
- Study start26 Jun 2017
- Primary completion8 Sep 2017
- Study completion8 Sep 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteersStudies 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
- Crossover
- Masking
- None (open label)
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- British American Tobacco (Investments) Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- LA Clinical Trials
- Responsible party
- Sponsor
- Investigators
- Mitchell Nides, PhD, Principal investigator, Los Angeles Clinical Trials
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03178981
- Sponsor's protocol ID
- BAT4217010
- Status last verified
- Dec 2022
- First submitted
- 6 Jun 2017
- Last updated
- 7 Dec 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pharmacokinetic Study to Examine Nicotine Delivery From E-cigarettes and a Conventional Cigarette in Healthy Subjects During a Brief Period of ad Libitum Use
- ClinicalTrials.gov ID
- NCT03178981
- Acronym / sponsor ID
- BAT4217010
- Conditions
- Healthy Volunteers, Smoking
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- British American Tobacco (Investments) LimitedIndustry (pharma, biotech, devices)
- Collaborators
- LA Clinical Trials
- Study start
- 26 Jun 2017 (actual)
- Primary completion
- 8 Sep 2017 (actual)
- Study completion
- 8 Sep 2017 (actual)
- First posted
- 7 Jun 2017 (actual)
- 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 will compare nicotine delivery and product satisfaction in healthy subjects either using several different types of electronic cigarettes or smoking a conventional cigarette.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Conventional cigarette | Active comparator | Other: Use electronic cigarette or smoke conventional cigaretteCommercially-available combustible cigarette |
| Second-generation e-cigarette A | Experimental | Other: Use electronic cigarette or smoke conventional cigarettePrototype second-generation (closed-tank) e-cigarette |
| Second-generation e-cigarette B | Experimental | Other: Use electronic cigarette or smoke conventional cigarettePrototype second-generation (closed-tank) e-cigarette |
| Second-generation e-cigarette C | Experimental | Other: Use electronic cigarette or smoke conventional cigarettePrototype second-generation (closed-tank) e-cigarette |
| Second-generation e-cigarette D | Experimental | Other: Use electronic cigarette or smoke conventional cigarettePrototype second-generation (closed-tank) e-cigarette |
| Second-generation e-cigarette E | Active comparator | Other: Use electronic cigarette or smoke conventional cigaretteCommercially-available second-generation (closed-tank) e-cigarette |
Who may qualify
- Ages
- 22 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (12 listed)
- Prior to study start, subjects must be current smokers of conventional factory-made cigarettes (eCO >10ppm at screening) who have either tried or are occasional users of e-cigarettes. Subjects must be smoking ≥10 cigarettes per day and must have done so for at least one year. Smoking status will be confirmed with a urinary cotinine level of ≥200ng/ml (determined using NicAlert cotinine test kit) and an exhaled breath CO level of >10ppm (determined using a Smokerlyzer breath CO monitor) at screening, as well as by tobacco use questionnaire.
- Subjects will be males or non-pregnant, non-lactating females, and between 22 and 55 years of age inclusive. Age verification will be performed by checking of Federal or state-issued ID (eg. passport or driving licence) during screening.
- Women of child-bearing potential should be using one of the following acceptable methods of contraception : combined (oestrogen and progestogen containing) oral, intravaginal or transdermal hormonal contraception associated with inhibition of ovulation; progestogen-only hormonal contraception, either oral, injected or implanted, associated with inhibition of ovulation; progestogen-only oral hormonal contraception where inhibition of ovulation is not the primary mode of action; intrauterine device (IUD); intrauterine hormone-releasing system (IUS); bilateral tubal occlusion; male or female condom with or without spermicide; cap, diaphragm or sponge with spermicide.
- Women of non-childbearing potential may be included if they are either surgically sterile (hysterectomy and/or oophorectomy) or postmenopausal for more than 1 year and must have a negative urine pregnancy test result during screening. Women who are surgically sterile must provide documentation of the procedure by an operative report.
- Male subjects must use an approved method of birth control during the entire study. These subjects must not donate sperm during this time.
Key exclusion criteria (22 listed)
- Subjects who have a history of, or clinically active significant, neurological, gastrointestinal, renal, hepatic, cardiovascular, psychiatric, respiratory, metabolic, endocrine, haematological disease or other major disorders.
- Subjects who have any clinically significant abnormal laboratory safety findings at Screening and prior to first product use, as determined by the PI or the appropriately qualified designee (1 repeat assessment is acceptable).
- Subjects who have previously been diagnosed with any form of malignancy.
- Subjects with significant allergies who in the opinion of the Principal Investigator or appropriately qualified designee should not be included.
- Subjects who have had an acute illness (e.g. upper respiratory tract infection, viral infection, etc.) requiring treatment within 4 weeks prior to Admission.
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 |
|---|---|---|
| Use electronic cigarette or smoke conventional cigaretteUse of electronic cigarette or smoking conventional cigarette ad libitum for 5 minute period | Other | Conventional cigarette, Second-generation e-cigarette A, Second-generation e-cigarette B, Second-generation e-cigarette C, Second-generation e-cigarette D, Second-generation e-cigarette E |
Primary outcome
Plasma nicotine concentration (Cmax)
Time frame: -5, 1, 3, 5, 6, 7, 9, 15, 45, and 60 minutes relative to the first puff on the cigarette/e-cigarette
Nicotine pharmacokinetics
Plasma nicotine concentration (Tmax)
Time frame: -5, 1, 3, 5, 6, 7, 9, 15, 45, and 60 minutes relative to the first puff on the cigarette/e-cigarette
Nicotine pharmacokinetics
Plasma nicotine concentration (AUC0-60)
Time frame: -5, 1, 3, 5, 6, 7, 9, 15, 45, and 60 minutes relative to the first puff on the cigarette/e-cigarette
Nicotine pharmacokinetics
3 secondary outcomes
Number of puffs taken
Time frame: During 5 minute ad libitum puffing period
Subjective measurement of product satisfaction
Time frame: After 60 minute blood sampling period
Mass loss from e-cigarette cartridge during puffing
Time frame: During 5 minute ad libitum puffing period
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 7 Dec 2022.
- Individual participant dataSharing planned: No
Related trials for Healthy Volunteers
Active, not recruitingPhase 1/2
Novel Biomarkers of Non-IgE Immediate Hypersensitivity Drug Reactions
Healthy Volunteer, Hypersensitivity Reactions
Active, not recruitingPhase 1/2
Study Evaluating ABCL635 for Vasomotor Symptoms of Menopause
Vasomotor Symptoms Associated With Menopause, Healthy Volunteers
Enrolling by invitationObservational study
Establishing Fibroblast-Derived Cell Lines From Skin Biopsies of Patients With Immunodeficiency or Immunodysregulation Disorders
Primary Immunodeficiency, DOCK8
Not yet recruiting
Positron Emission Tomography and Organ-Specific Changes in Participants Co-Enrolled in NIH Studies of Plasmodium Vivax Controlled Human Malaria Infection
Healthy Volunteer, Malaria
Enrolling by invitation
Development and Evaluation of Magnetic Resonance Imaging Acquisition and Analysis Methods
Healthy
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.
Mitchell Nides, PhD principal investigator
Los Angeles Clinical Trials
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Use electronic cigarette or smoke conventional cigarette in people with Healthy Volunteers and Smoking, run by British American Tobacco (Investments) Limited 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 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 7 Dec 2022. 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?
Plasma nicotine concentration (Cmax) (time frame: -5, 1, 3, 5, 6, 7, 9, 15, 45, and 60 minutes relative to the first puff on the cigarette/e-cigarette). The study lists 3 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 7 Dec 2022.