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Completed

NCT Number: NCT02032212

A Bioavailability Study of Nicotine Delivered by an Electronic Vapour Product

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.

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Key information

Conditions

Healthy Volunteers

Age range

21 year–65 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Simbec Research

Merthyr Tydfil, Wales, CF48 4DR, United Kingdom

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

EVP unflavoured

Other

EVP flavoured

Other

Nicotine inhalator

Other

15 mg nicotine Nicorette

Conventional cigarette

Other

Primary outcomes

  1. 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)

  2. 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

Secondary outcomes

  1. Exhaled Carbon Monoxide

    Time frame: 25 minutes

    Measured with a Smokerlyser device

  2. Nicotine Withdrawal Symptoms

    Time frame: 30 minutes after the third product use

    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.

  3. Nicotine Craving

    Time frame: 30 minutes after the third product use

    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.

Sponsors and collaborators

Lead sponsor

Imperial Brands PLC

Industry

Registry information

Official study title

A Randomised, Crossover, Relative Bioavailability Study of Nicotine Delivered by an Electronic Vapour Product, a Nicotine Inhalator and a Conventional Cigarette

Important dates

Study start
2013
Primary completion
2014
Study completion
2015
First posted
Jan 9, 2014
Registry last updated
Sep 10, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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