Healthy VolunteersNCT02032212
A Bioavailability Study of Nicotine Delivered by an Electronic Vapour Product
A study testing EVP unflavoured, EVP flavoured and Nicotine inhalator in people with Healthy Volunteers, run by Imperial Brands PLC at 1 site in United Kingdom.
Trial summary
Electronic Vapour Products (EVPs) are a relatively new class of consumer products that are otherwise known as electronic cigarettes. These may look like conventional cigarettes but do not contain tobacco. Read more about this study
- Who is it for?
- Ages 21 to 65 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- EVP unflavoured, EVP flavoured and Nicotine inhalator
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Dec 2013to Dec 2015
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 65 years
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- BMI of 18-35kg/m2
- Subjects must be established smokers
- Subjects must have smoked five to 30 cigarettes per day for at least one year
Who cannot join
- Subjects who have used nicotine replacement therapy within 14 days of the screening
- Subjects who have donated blood within 12 months preceding study
- Subjects with relevant illness history
- Subjects positive for hepatitis or HIV
- Subjects with history of drug or alcohol abuse
- Subjects with lung function test or vital signs considered unsuitable
- Subjects who are trying to stop smoking
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomised, Crossover, Relative Bioavailability Study of Nicotine Delivered by an Electronic Vapour Product, a Nicotine Inhalator and a Conventional Cigarette
Electronic Vapour Products (EVPs) are a relatively new class of consumer products that are otherwise known as electronic cigarettes. These may look like conventional cigarettes but do not contain tobacco.
The 'vapour' produced by such devices typically consists of humectants (propylene glycol or glycerol), nicotine, water, and flavours.
This trial is to evaluate the pharmacokinetic profile of an EVP.
Read the detailed description
The principal part of this study evaluates the nicotine pharmacokinetic profile of conventional cigarettes, a nicotine inhalator, an unflavoured EVP and a flavoured EVP.
A second part investigates the nicotine delivery of an EVP with four different nicotine doses.
- Conditions
- Healthy Volunteers
- Being tested
- EVP unflavoured, EVP flavoured, Nicotine inhalator, Conventional cigarette
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EVP unflavouredOther
EVP flavouredOther
Nicotine inhalatorOther
15 mg nicotine Nicorette
Conventional cigaretteOther
| Study group | Role | What they receive |
|---|---|---|
| Sequence 1 | Experimental | Subjects use the unflavoured EVP on Day 1, the flavoured EVP on Day 2, the nicotine inhalator on Day 3 and the conventional cigarette on Day 4. Receives: Other: EVP unflavoured; Other: EVP flavoured; Other: Nicotine inhalator; Other: Conventional cigarette |
| Sequence 2 | Experimental | Subjects use the flavoured EVP on Day 1, the unflavoured EVP on Day 2, the conventional cigarette on Day 3 and the nicotine inhalator on Day 4. Receives: Other: EVP unflavoured; Other: EVP flavoured; Other: Nicotine inhalator; Other: Conventional cigarette |
| Sequence 3 | Experimental | Subjects use the nicotine inhalator on Day 1, the conventional cigarette on Day 2, the unflavoured EVP on Day 3 and the flavoured EVP on Day 4. Receives: Other: EVP unflavoured; Other: EVP flavoured; Other: Nicotine inhalator; Other: Conventional cigarette |
| Sequence 4 | Experimental | Subjects use the conventional cigarette on Day 1, the nicotine inhalator on Day 2, the flavoured EVP on Day 3 and the unflavoured EVP on Day 4. Receives: Other: EVP unflavoured; Other: EVP flavoured; Other: Nicotine inhalator; Other: Conventional cigarette |
What is being measured
The primary outcome is the main question the study is designed to answer.
Nicotine Plasma Concentration
Maximum plasma nicotine concentration (Cmax)
Measured: 1, 2, 3, 4, 5, 6, 7, 8, 10, 13, 15, 30, 45, 60 minutes, 2, 4, 6, 8, 12 and 21 hours
Area Under the Concentration-time Curve for Plasma Nicotine (AUCt)
Measured: 1, 2, 3, 4, 5, 6, 7, 8, 10, 13, 15, 30, 45, 60 minutes, 2, 4, 6, 8, 12 and 21 hours
Secondary outcomes (3)
Exhaled Carbon Monoxide
Measured with a Smokerlyser device
Measured: 25 minutes
Nicotine Withdrawal Symptoms
Withdrawal symptoms were evaluated with the Minnesota Nicotine Withdrawal Scale questionnaire, to which only the 15 questions of the subject's part were completed. Subjects had to rate behaviours (e.g. angry, irritable, frustrated, depressed, restless, insomnia) from 0 (none) to 4 (severe). A higher score means more severe withdrawal symptoms. Scores range from a minimum of 0 to a maximum of 60.
Measured: 30 minutes after the third product use
Nicotine Craving
Craving was assessed with the Brief Questionnaire of Smoking Urges (QSU-Brief). Subject had to rate 10 statements, such as "I have a desire for a cigarette right now", by a number ranging from 1 (strongly disagree) to 7 (strongly agree). Scores can range from a minimum of 0 to a maximum of 70. A higher score means a stronger urge to smoke a cigarette.
Measured: 30 minutes after the third product use
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jan 2014 (estimated)
- Study startDec 2013
- Primary completionMay 2014
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- 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
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Imperial Brands PLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Girish Sharma, MD, Principal investigator, Simbec Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02032212
- Sponsor's protocol ID
- ITG EVP G1 S1
- Status last verified
- Sep 2025
- First submitted
- 6 Jan 2014
- Last updated
- 10 Sep 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomised, Crossover, Relative Bioavailability Study of Nicotine Delivered by an Electronic Vapour Product, a Nicotine Inhalator and a Conventional Cigarette
- ClinicalTrials.gov ID
- NCT02032212
- Acronym / sponsor ID
- ITG EVP G1 S1
- Conditions
- Healthy Volunteers
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Imperial Brands PLCIndustry (pharma, biotech, devices)
- Study start
- Dec 2013
- Primary completion
- May 2014 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 9 Jan 2014 (estimated)
- Results
- Posted 2 May 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Electronic Vapour Products (EVPs) are a relatively new class of consumer products that are otherwise known as electronic cigarettes. These may look like conventional cigarettes but do not contain tobacco.
The 'vapour' produced by such devices typically consists of humectants (propylene glycol or glycerol), nicotine, water, and flavours.
This trial is to evaluate the pharmacokinetic profile of an EVP.
Detailed description
The principal part of this study evaluates the nicotine pharmacokinetic profile of conventional cigarettes, a nicotine inhalator, an unflavoured EVP and a flavoured EVP.
A second part investigates the nicotine delivery of an EVP with four different nicotine doses.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Sequence 1 | Experimental | Other: EVP unflavoured, Other: EVP flavoured, Other: Nicotine inhalator, Other: Conventional cigaretteSubjects use the unflavoured EVP on Day 1, the flavoured EVP on Day 2, the nicotine inhalator on Day 3 and the conventional cigarette on Day 4. |
| Sequence 2 | Experimental | Other: EVP unflavoured, Other: EVP flavoured, Other: Nicotine inhalator, Other: Conventional cigaretteSubjects use the flavoured EVP on Day 1, the unflavoured EVP on Day 2, the conventional cigarette on Day 3 and the nicotine inhalator on Day 4. |
| Sequence 3 | Experimental | Other: EVP unflavoured, Other: EVP flavoured, Other: Nicotine inhalator, Other: Conventional cigaretteSubjects use the nicotine inhalator on Day 1, the conventional cigarette on Day 2, the unflavoured EVP on Day 3 and the flavoured EVP on Day 4. |
| Sequence 4 | Experimental | Other: EVP unflavoured, Other: EVP flavoured, Other: Nicotine inhalator, Other: Conventional cigaretteSubjects use the conventional cigarette on Day 1, the nicotine inhalator on Day 2, the flavoured EVP on Day 3 and the unflavoured EVP on Day 4. |
Who may qualify
- Ages
- 21 to 65 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- BMI of 18-35kg/m2
- Subjects must be established smokers
- Subjects must have smoked five to 30 cigarettes per day for at least one year
Key exclusion criteria (7 listed)
- Subjects who have used nicotine replacement therapy within 14 days of the screening
- Subjects who have donated blood within 12 months preceding study
- Subjects with relevant illness history
- Subjects positive for hepatitis or HIV
- Subjects with history of drug or alcohol abuse
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 |
|---|---|---|
| EVP unflavoured | Other | Sequence 1, Sequence 2, Sequence 3, Sequence 4 |
| EVP flavoured | Other | Sequence 1, Sequence 2, Sequence 3, Sequence 4 |
| Nicotine inhalator15 mg nicotine Nicorette | Other | Sequence 1, Sequence 2, Sequence 3, Sequence 4 |
| Conventional cigarette | Other | Sequence 1, Sequence 2, Sequence 3, Sequence 4 |
Primary outcome
Nicotine Plasma Concentration
Time frame: 1, 2, 3, 4, 5, 6, 7, 8, 10, 13, 15, 30, 45, 60 minutes, 2, 4, 6, 8, 12 and 21 hours
Maximum plasma nicotine concentration (Cmax)
Area Under the Concentration-time Curve for Plasma Nicotine (AUCt)
Time frame: 1, 2, 3, 4, 5, 6, 7, 8, 10, 13, 15, 30, 45, 60 minutes, 2, 4, 6, 8, 12 and 21 hours
3 secondary outcomes
Exhaled Carbon Monoxide
Time frame: 25 minutes
Nicotine Withdrawal Symptoms
Time frame: 30 minutes after the third product use
Nicotine Craving
Time frame: 30 minutes after the third product use
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Sep 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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.
Girish Sharma, MD principal investigator
Simbec 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 EVP unflavoured, EVP flavoured and Nicotine inhalator in people with Healthy Volunteers, run by Imperial Brands PLC at 1 site in United Kingdom.
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 3 inclusion and 7 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 10 Sep 2025. 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 Kingdom. 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?
Yes. Results are posted in the registry (first posted 2 May 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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 Plasma Concentration (time frame: 1, 2, 3, 4, 5, 6, 7, 8, 10, 13, 15, 30, 45, 60 minutes, 2, 4, 6, 8, 12 and 21 hours). 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 10 Sep 2025.