Nicotine absorption from electronic cigarettes
| ISRCTN | ISRCTN69827722 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN69827722 |
| Secondary identifying numbers | N/A |
- Submission date
- 12/02/2014
- Registration date
- 28/02/2014
- Last edited
- 21/01/2019
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Mental and Behavioural Disorders
Plain English summary of protocol
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
Contact information
Scientific
Eslin 12
LAMIA
35100
Greece
| Phone | +306977454837 |
|---|---|
| kfarsalinos@gmail.com |
Study information
| Study design | Open-label non randomised clinical trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Non randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Screening |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | Nicotine absorption from electronic cigarette use: comparison between experienced and naive users |
| Study objectives | 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(s) | Ethics Committee of Onassis Cardiac Surgery Center, 25/06/2013 |
| Health condition(s) or problem(s) studied | 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 |
| Primary outcome measure | 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 study start date | 15/09/2013 |
| Completion date | 15/11/2013 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 50 |
| Key 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. |
| Key exclusion criteria | 1. Suspicion of pregnancy 2. History of hematological abnormalitites 3. Inability to provide blood samples 4. Unwillingness to sign informed consent |
| Date of first enrolment | 15/09/2013 |
| Date of final enrolment | 15/11/2013 |
Locations
Countries of recruitment
- Greece
Study participating centre
35100
Greece
Sponsor information
Research organisation
P.O. Box 184
Englewood, Ohio
45322
United States of America
| Website | http://www.aemsa.org/ |
|---|
Funders
Funder type
Other
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 17/06/2015 | 21/01/2019 | Yes | No |
Editorial Notes
21/01/2019: Publication reference added
