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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
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| 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. |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| EVP unflavoured | Other |
| ||
| EVP flavoured |
| Measure | Description | Time Frame |
|---|---|---|
| Nicotine Plasma Concentration | Maximum plasma nicotine concentration (Cmax) | 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) | 1, 2, 3, 4, 5, 6, 7, 8, 10, 13, 15, 30, 45, 60 minutes, 2, 4, 6, 8, 12 and 21 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Exhaled Carbon Monoxide | Measured with a Smokerlyser device | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Girish Sharma, MD | Simbec Research | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Simbec Research | Merthyr Tydfil | Wales | CF48 4DR | United Kingdom |
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| ID | Title | Description |
|---|---|---|
| FG000 | Sequence 1 | Subjects in this arm used the unflavoured EVP on Day 1, the flavoured EVP on Day 2, Nicotine inhalator on Day 3 and the conventional cigarette on Day 4. |
| FG001 | Sequence 2 | Subjects in this arm used 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. |
| FG002 | Sequence 3 | Subjects in this arm used 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. |
| FG003 | Sequence 4 | Subjects in this arm used 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Sequence 1 | Subjects in this arm used the unflavoured EVP on Day 1, the flavoured EVP on Day 2, Nicotine inhalator on Day 3 and the conventional cigarette on Day 4. |
| BG001 | Sequence 2 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Nicotine Plasma Concentration | Maximum plasma nicotine concentration (Cmax) | Posted | Geometric Mean | Geometric Coefficient of Variation | ng/ml | 1, 2, 3, 4, 5, 6, 7, 8, 10, 13, 15, 30, 45, 60 minutes, 2, 4, 6, 8, 12 and 21 hours |
|
5 days
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | EVP Unflavoured | Unflavoured e-vapour product |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Glossodynia | Gastrointestinal disorders | MedDRA (16.1) | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Tanvir Walele | Imperial Tobacco Group | 0044 177 933 7589 | tanvir.walele@uk.imptob.com |
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| Other |
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| Nicotine inhalator | Other | 15 mg nicotine Nicorette |
|
| Conventional cigarette | Other |
|
| 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. | 30 minutes after the third product use |
Subjects in this arm used 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.
| BG002 | Sequence 3 | Subjects in this arm used the Nicotine inhalator on Day 1 and the conventional cigarette on Day 2, the unflavoured EVP on Day 3 and the flavoured EVP on Day 4. |
| BG003 | Sequence 4 | Subjects in this arm used the conventional cigarette on Day 1, the Nicotine inhalator on Day 2, the flavoured EVP on Day 3, the unflavoured EVP on Day 4. |
| BG004 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
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| OG003 | Conventional Cigarette | Conventional cigarette (commercially available) |
|
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| Primary | Area Under the Concentration-time Curve for Plasma Nicotine (AUCt) | Posted | Geometric Mean | Geometric Coefficient of Variation | min*ng/ml | 1, 2, 3, 4, 5, 6, 7, 8, 10, 13, 15, 30, 45, 60 minutes, 2, 4, 6, 8, 12 and 21 hours |
|
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| Secondary | Exhaled Carbon Monoxide | Measured with a Smokerlyser device | Posted | Mean | Standard Deviation | ppm | 25 minutes |
|
|
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| Secondary | 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. | Posted | Mean | Standard Deviation | score on a scale | 30 minutes after the third product use |
|
|
|
| Secondary | 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. | Posted | Mean | Standard Deviation | score on a scale | 30 minutes after the third product use |
|
|
|
| 0 |
| 12 |
| 1 |
| 12 |
| EG001 | EVP Flavoured | Flavoured e-vapour product | 0 | 12 | 3 | 12 |
| EG002 | Nicotine Inhalator | Nicotine inhalator 15mg | 0 | 12 | 3 | 12 |
| EG003 | Conventional Cigarette | Conventional cigarette (commercially available) | 0 | 12 | 0 | 12 |
| Nasopharyngitis | Infections and infestations | MedDRA (16.1) | Systematic Assessment |
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| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA (16.1) | Systematic Assessment |
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| Throat irritation | Respiratory, thoracic and mediastinal disorders | MedDRA (16.1) | Systematic Assessment |
|
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