A Bioavailability Study of Nicotine Delivered by an Electronic Vapour Product

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

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.

Study Overview

• Status: Completed
• Conditions: Healthy Volunteers
• Intervention / Treatment: Other: EVP unflavoured; Other: EVP flavoured; Other: Nicotine inhalator; Other: Conventional cigarette

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 Type: Interventional
• Enrollment (Actual): 12
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United Kingdom
  • Wales
    • Merthyr Tydfil, Wales, United Kingdom, CF48 4DR
      • Simbec Research

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 17 years to 61 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Sequence 1; 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.	Other: EVP unflavoured; Other: EVP flavoured; Other: Nicotine inhalator; 15 mg nicotine Nicorette; Other: Conventional cigarette
Experimental: Sequence 2; 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.	Other: EVP unflavoured; Other: EVP flavoured; Other: Nicotine inhalator; 15 mg nicotine Nicorette; Other: Conventional cigarette
Experimental: Sequence 3; 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.	Other: EVP unflavoured; Other: EVP flavoured; Other: Nicotine inhalator; 15 mg nicotine Nicorette; Other: Conventional cigarette
Experimental: Sequence 4; 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.	Other: EVP unflavoured; Other: EVP flavoured; Other: Nicotine inhalator; 15 mg nicotine Nicorette; Other: Conventional cigarette

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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.	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

Collaborators and Investigators

• Sponsor: Imperial Brands PLC
• Investigators: Principal Investigator: Girish Sharma, MD, Simbec Research

Study record dates

Study Major Dates

• Study Start: December 1, 2013
• Primary Completion (Actual): May 1, 2014
• Study Completion (Actual): December 1, 2015

Study Registration Dates

• First Submitted: January 6, 2014
• First Submitted That Met QC Criteria: January 7, 2014
• First Posted (Estimated): January 9, 2014

Study Record Updates

• Last Update Posted (Estimated): September 10, 2025
• Last Update Submitted That Met QC Criteria: September 9, 2025
• Last Verified: September 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Autonomic Agents; Peripheral Nervous System Agents; Cholinergic Agents; Ganglionic Stimulants; Nicotinic Agonists; Cholinergic Agonists; Nicotine
• Other Study ID Numbers: ITG EVP G1 S1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO