Condition category
Mental and Behavioural Disorders
Date applied
12/02/2014
Date assigned
28/02/2014
Last edited
28/02/2014
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Electronic cigarettes have been recently marketed as an alternative to smoking. Limited information is available about the nicotine pharmacokinetics (the action of nicotine in the body over a period of time) from using such devices. The purpose of this study is to evaluate nicotine absorption from electronic cigarette use and compare experienced users with naive users.

Who can participate?
Healthy smokers and healthy electronic cigarette users.

What does the study involve?
At the start of the study both experienced smokers and naive users will have to abstain from nicotine intake for at least 8 hours, then nicotine levels will be measured. Subsequently they will be given an electronic cigarette device with a nicotine liquid. They will use the device for 5 minutes taking 10 puffs and for 60 more minutes taking as many puffs as they like. Blood samples for nicotine measurements will be obtained at 5 min, 20 min, 35 min, 50 min and 65 min. The blood samples will be collected through a catheter that will be inserted into a vein.

What are the possible benefits and risks of participating?
There is minimal risk associated with obtaining blood samples through a venous catheter. An increase in anxiety may be experienced due to not smoking and not using electronic cigarettes for 8 hours. Nicotine craving symptoms may be expected, but will be relieved after the initial blood sample collection.

Where is the study run from?
Onassis Cardiac Surgery Center, Greece.

When is the study starting and how long is it expected to run for?
The study started in September 2013 and recruitment completed in November 2013.

Who is funding the study?
American E-liquid Manufacturing Standards Association (AEMSA).

Who is the main contact?
Dr Konstantinos Farsalinos
kfarsalinos@gmail.com

Trial website

Contact information

Type

Scientific

Primary contact

Dr Konstantinos Farsalinos

ORCID ID

Contact details

Eslin 12
LAMIA
35100
Greece
+306977454837
kfarsalinos@gmail.com

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Nicotine absorption from electronic cigarette use: comparison between experienced and naive users

Acronym

Study hypothesis

We hypothesize that naive electronic cigarette users may use the devices less intensively compared to experienced users; therefore, nicotine is absorbed slower and in lower amounts.

Ethics approval

Ethics Committee of Onassis Cardiac Surgery Center, 25/06/2013

Study design

Open-label non randomised clinical trial

Primary study design

Interventional

Secondary study design

Non randomised controlled trial

Trial setting

Hospitals

Trial type

Screening

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Smoking addiction

Intervention

Group 1: Experienced vapers
Group 2: Naive vapers (which were long-term smokers, with at least 5 years smoking duration)

Use of an electronic cigarette device with nicotine-containing liquid for a total of 65 minutes.

Both were given electronic cigarettes and the results will be compared between groups.

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

Plasma nicotine levels at 5 min, 20 min, 35 min, 50 min and 65 min of use.

Secondary outcome measures

No secondary outcome measures

Overall trial start date

15/09/2013

Overall trial end date

15/11/2013

Reason abandoned

Eligibility

Participant inclusion criteria

1. Clinically healthy individuals, both genders, 16-80 years old
2. No history of cardiovascular or other disease
3. Not taking any medications
4. Not pregnant
5. No risk factors for cardiovascular disease (besides smoking)
6. No history of fainting or feeling faint when obtaining blood samples.
7. Daily smokers for at least one year consuming at least 10 cigarettes per day for the group of naive electronic cigarette users.
8. Daily electronic cigarette users of at least one month who had quit smoking for at least one month for the group of experienced electronic cigarette users.

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

50

Participant exclusion criteria

1. Suspicion of pregnancy
2. History of hematological abnormalitites
3. Inability to provide blood samples
4. Unwillingness to sign informed consent

Recruitment start date

15/09/2013

Recruitment end date

15/11/2013

Locations

Countries of recruitment

Greece

Trial participating centre

Eslin 12
LAMIA
35100
Greece

Sponsor information

Organisation

American E-liquid Manufacturing Standards Association (AEMSA) (USA)

Sponsor details

P.O. Box 184
Englewood
Ohio
45322
United States of America

Sponsor type

Research organisation

Website

http://www.aemsa.org/

Funders

Funder type

Other

Funder name

American E-liquid Manufacturing Standards Association (AEMSA)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes