An interventional study of EVP unflavoured and EVP flavoured in Healthy Volunteers, sponsored by Imperial Brands PLC. Completed at 1 site in United Kingdom. Open to male participants aged 21 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-09-10.
Sponsored by Imperial Brands PLC · Not applicable, Interventional, and Other
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.
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.
Imperial Brands PLC is the lead sponsor of 7 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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.
Other: EVP unflavoured · Other: EVP flavoured · Other: Nicotine inhalator · Other: Conventional cigarette
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.
Other: EVP unflavoured · Other: EVP flavoured · Other: Nicotine inhalator · Other: Conventional cigarette
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.
Other: EVP unflavoured · Other: EVP flavoured · Other: Nicotine inhalator · Other: Conventional cigarette
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.
Other: EVP unflavoured · Other: EVP flavoured · Other: Nicotine inhalator · Other: Conventional cigarette
15 mg nicotine Nicorette
Nicotine Plasma Concentration
Maximum plasma nicotine concentration (Cmax)
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
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
Exhaled Carbon Monoxide
Measured with a Smokerlyser device
Time frame: 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.
Time frame: 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.
Time frame: 30 minutes after the third product use
| Milestone | Sequence 1 | Sequence 2 | Sequence 3 | Sequence 4 |
|---|---|---|---|---|
| Started | 3 | 3 | 3 | 3 |
| Completed | 3 | 3 | 3 | 3 |
| Not completed | 0 | 0 | 0 | 0 |
Maximum plasma nicotine concentration (Cmax)
| ng/ml | EVP Unflavoured | EVP Flavoured | Nicotine Inhalator | Conventional Cigarette |
|---|---|---|---|---|
| Nicotine Plasma Concentration | 3.6 ± 33.9 | 2.5 ± 41.6 | 2.5 ± 45.2 | 21.2 ± 43.1 |
| min*ng/ml | EVP Unflavoured | EVP Flavoured | Nicotine Inhalator | Conventional Cigarette |
|---|---|---|---|---|
| Area Under the Concentration-time Curve for Plasma Nicotine (AUCt) | 425.3 ± 31.4 | 277.2 ± 33.7 | 320.6 ± 47.6 | 2247.0 ± 28.6 |
Measured with a Smokerlyser device
| ppm | EVP Unflavoured | EVP Flavoured | Nicotine Inhalator | Conventional Cigarette |
|---|---|---|---|---|
| Exhaled Carbon Monoxide | 2.5 ± 1.0 | 2.2 ± 0.72 | 2.3 ± 0.78 | 14.8 ± 3.86 |
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.
| score on a scale | EVP Unflavoured | EVP Flavoured | Nicotine Inhalator | Conventional Cigarette |
|---|---|---|---|---|
| Nicotine Withdrawal Symptoms | 6.40 ± 6.52 | 6.80 ± 7.32 | 7.50 ± 7.08 | 8.10 ± 8.93 |
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.
| score on a scale | EVP Unflavoured | EVP Flavoured | Nicotine Inhalator | Conventional Cigarette |
|---|---|---|---|---|
| Nicotine Craving | 24.8 ± 11.5 | 25.0 ± 12.9 | 25.6 ± 12.0 | 22.8 ± 14.2 |
Collected over 5 days. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| EVP Unflavoured | — | 0/12 (0%) | 1/12 (8.3%) |
| EVP Flavoured | — | 0/12 (0%) | 3/12 (25%) |
| Nicotine Inhalator | — | 0/12 (0%) | 3/12 (25%) |
| Conventional Cigarette | — | 0/12 (0%) | 0/12 (0%) |
| Event | EVP Unflavoured | EVP Flavoured | Nicotine Inhalator | Conventional Cigarette |
|---|---|---|---|---|
| CoughRespiratory, thoracic and mediastinal disorders | 1/12 | 1/12 | 2/12 | 0/12 |
| GlossodyniaGastrointestinal disorders | 0/12 | 0/12 | 1/12 | 0/12 |
| NasopharyngitisInfections and infestations | 0/12 | 1/12 | 0/12 | 0/12 |
| Throat irritationRespiratory, thoracic and mediastinal disorders | 0/12 | 1/12 | 1/12 | 0/12 |
| Age, Categorical(Participants) | Sequence 1 | Sequence 2 | Sequence 3 | Sequence 4 | Total |
|---|---|---|---|---|---|
| <=18 years | 0 | 0 | 0 | 0 | 0 |
| Between 18 and 65 years | 3 | 3 | 3 | 3 | 12 |
| >=65 years | 0 | 0 | 0 | 0 | 0 |
| Sex: Female, Male(Participants) | Sequence 1 | Sequence 2 | Sequence 3 | Sequence 4 | Total |
|---|---|---|---|---|---|
| Female | 0 | 0 | 0 | 0 | 0 |
| Male | 3 | 3 | 3 | 3 | 12 |
| Region of Enrollment(participants) | Sequence 1 | Sequence 2 | Sequence 3 | Sequence 4 | Total |
|---|---|---|---|---|---|
| United Kingdom | 3 | 3 | 3 | 3 | 12 |
Plan to share: No
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Imperial Brands PLC