A Bioavailability Study of Nicotine Delivered by an Electronic Vapour Product

Phase 1

Completed

• Conditions: Healthy Volunteers

• Registration Number: NCT02032212
• Lead Sponsor: Imperial Brands PLC

Brief 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.

Detailed 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.

Study Timeline

• Study Start: 2013-12
• Study First Submitted: 2014-01-06
• Study First Submitted QC: 2014-01-07
• Study First Posted: 2014-01-09
• Primary Completion: 2014-05
• Study Completion: 2015-12
• Results First Submitted: 2016-02-12
• Status Verified: 2016-04
• Results First Submitted QC: 2016-04-25
• Last Update Submitted: 2016-04-25
• Results First Posted: 2016-05-02
• Last Update Posted: 2016-05-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 12

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

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Primary Outcome Measures

Name	Time	Method
Nicotine Plasma Concentration	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)
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

Secondary Outcome Measures

Name	Time	Method
Exhaled Carbon Monoxide	25 minutes	Measured with a Smokerlyser device
Nicotine Withdrawal Symptoms	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.
Nicotine Craving	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.

Trial Locations

Locations (1)

Simbec Research; 🇬🇧 Merthyr Tydfil, Wales, United Kingdom