A Bioavailability Study of Nicotine Delivered by an Electronic Vapour Product

Healthy Volunteers Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02032212
• Other study ID #: ITG EVP G1 S1
• Status: Completed
• Phase: Phase 1
• First received: January 6, 2014
• Last updated: April 25, 2016
• Start date: December 2013
• Est. completion date: December 2015

Study information

• Verified date: April 2016
• Source: Imperial Tobacco Group PLC
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency
• Study type: Interventional

Clinical 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.

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: December 2015
• Est. primary completion date: May 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 21 Years to 65 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Crossover Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Healthy Volunteers

Intervention

Other:
• EVP unflavoured

• EVP flavoured

• Nicotine inhalator
15 mg nicotine Nicorette
• Conventional cigarette

Locations

Country	Name	City	State
United Kingdom	Simbec Research	Merthyr Tydfil	Wales

Sponsors (1)

Lead Sponsor	Collaborator
Imperial Tobacco Group PLC

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	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	No
Secondary	Exhaled Carbon Monoxide	Measured with a Smokerlyser device	25 minutes	Yes
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.	30 minutes after the third product use	No
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.	30 minutes after the third product use	No