N/A
N=12
A Bioavailability Study of Nicotine Delivered by an Electronic Vapour Product
Healthy Volunteers
Bottom Line
View on ClinicalTrials.gov: NCT02032212 ↗Enrolled (actual)
12
Serious AEs
0.0%
Results posted
May 2016
Primary outcome: Primary: Nicotine Plasma Concentration — 3.6; 2.5; 2.5; 21.2 ng/ml
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- EVP unflavoured (Other); EVP flavoured (Other); Nicotine inhalator (Other); Conventional cigarette (Other)
- Age
- Adult, Older Adult · 21+ yrs
- Sex
- Male
- Sponsor
- Imperial Brands PLC
- Primary completion
- May 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Nicotine Plasma Concentration |
3.6; 2.5; 2.5; 21.2 | — |
| PRIMARY Area Under the Concentration-time Curve for Plasma Nicotine (AUCt) |
425.3; 277.2; 320.6; 2247.0 | — |
| SECONDARY Exhaled Carbon Monoxide |
2.5; 2.2; 2.3; 14.8 | — |
| SECONDARY Nicotine Withdrawal Symptoms |
6.40; 6.80; 7.50; 8.10 | — |
| SECONDARY Nicotine Craving |
24.8; 25.0; 25.6; 22.8 | — |
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.
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.
Eligibility Criteria
Inclusion Criteria
- 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
Exclusion Criteria
- 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
Data sourced from ClinicalTrials.gov (NCT02032212). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.