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A Bioavailability Study of Nicotine Delivered by an Electronic Vapour Product

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ClinicalTrials.gov Identifier: NCT02032212
Recruitment Status : Completed
First Posted : January 9, 2014
Results First Posted : May 2, 2016
Last Update Posted : May 2, 2016
Sponsor:
Information provided by (Responsible Party):
Imperial Tobacco Group 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.


Condition or disease Intervention/treatment Phase
Healthy Volunteers Other: EVP unflavoured Other: EVP flavoured Other: Nicotine inhalator Other: Conventional cigarette Phase 1

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 12 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Official Title: A Randomised, Crossover, Relative Bioavailability Study of Nicotine Delivered by an Electronic Vapour Product, a Nicotine Inhalator and a Conventional Cigarette
Study Start Date : December 2013
Actual Primary Completion Date : May 2014
Actual Study Completion Date : December 2015

Resource links provided by the National Library of Medicine


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



Primary Outcome Measures :
  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 Outcome Measures :
  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.



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Ages Eligible for Study:   21 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02032212


Locations
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United Kingdom
Simbec Research
Merthyr Tydfil, Wales, United Kingdom, CF48 4DR
Sponsors and Collaborators
Imperial Tobacco Group PLC
Investigators
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Principal Investigator: Girish Sharma, MD Simbec Research

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Responsible Party: Imperial Tobacco Group PLC
ClinicalTrials.gov Identifier: NCT02032212     History of Changes
Other Study ID Numbers: ITG EVP G1 S1
First Posted: January 9, 2014    Key Record Dates
Results First Posted: May 2, 2016
Last Update Posted: May 2, 2016
Last Verified: April 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Nicotine
Ganglionic Stimulants
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Nicotinic Agonists
Cholinergic Agonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action