Ignite Creation Date:
2024-05-06 @ 11:51 AM
Last Modification Date:
2024-10-26 @ 12:50 PM
Study NCT ID:
NCT03612544
Status:
COMPLETED
Last Update Posted:
2023-11-15
First Post:
2018-07-02
Brief Title:
The ESTxENDS Trial- Substudy on the Effect on Toxins From Using Electronic Nicotine Delivery Systems ENDSVaporizerE-cig
Sponsor:
University of Bern
Organization:
University of Bern
Study Overview
Official Title:
Substudy of Efficacy Safety and Toxicology of Electronic Nicotine Delivery Systems as an Aid for Smoking Cessation ESTxENDS Trial- the Toxins Substudy of ESTxENDS
Status:
COMPLETED
Status Verified Date:
2023-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ESTxENDS
Brief Summary:
-- This is a substudy of the main ESTxENDS trial NCT03589989 Toxins outcomes should be considered secondary outcomes of the main smoking cessation outcome formulated in NCT03589989
Cigarette smoking is the leading cause of preventable death in Switzerland Recently electronic nicotine delivery systems ENDS also called vaporizer or electronic cigarette have become popular with smokers who want to stop smoking or reduce their exposure to inhaled chemicals since ENDS use appears to be safer than tobacco smoking
Conventional cigarettes release toxic chemicals in tobacco smoke through thermochemical degradation and pyrolysis processes by combusting tobacco but in ENDS toxicants can be released by heating up nicotine-containing e-liquids to produce vapor The e-liquid in ENDS is mostly made of propylene glycol PG and vegetal glycerin VG in addition to nicotine flavorings and sometimes alcohol as a conservation agent The heating process of the e-liquid in ENDS has been shown to release carcinogens such as some carbonyl and volatile organic compounds ie formaldehyde acetaldehyde and acrolein Some devices might also release heavy metals such as cadmium lead and mercury The source of such metals may be the metal of the device or the e-liquids Although unexpected from the composition of the e-liquids some studies have also detected tobacco-specific nitrosamines TNSAs N-nitrosonornicotine NNN and 4-methylnitrosoamino-1-3-pyridyl-1-butanone NNK and polycyclic aromatic hydrocarbons PAHs 1- and 2-Naphtol and 1-hydroxypyrene 1-OHP
This study will therefore test the efficacy of ENDS for cigarette smoking cessation the safety of ENDS on adverse events and the effect of ENDS on health-related outcomes and exposure to inhaled chemicals
For the main ESTxENDS trial NCT03589989 cigarette smokers motivated to quit smoking cigarettes will be included Participants in the intervention group will receive an ENDS and nicotine-containing e-liquids which they will be allowed to use ad libitum Additionally they will receive smoking cessation counseling Participants in the control group will receive smoking cessation counseling only All participants will be followed over a 24-month period Chemicals such as VOCs PAHs TSNAs heavy metals nicotine and nicotine degradation products will first be quantified in the aerosol produced by ENDS in laboratory conditions These chemicals and their metabolites will then be measured at baseline and at 6- 12- and 24- months follow-up in urine samples from study participants
Cigarette smoking is the leading cause of preventable death in Switzerland Recently electronic nicotine delivery systems ENDS also called vaporizer or electronic cigarette have become popular with smokers who want to stop smoking or reduce their exposure to inhaled chemicals since ENDS use appears to be safer than tobacco smoking
Conventional cigarettes release toxic chemicals in tobacco smoke through thermochemical degradation and pyrolysis processes by combusting tobacco but in ENDS toxicants can be released by heating up nicotine-containing e-liquids to produce vapor The e-liquid in ENDS is mostly made of propylene glycol PG and vegetal glycerin VG in addition to nicotine flavorings and sometimes alcohol as a conservation agent The heating process of the e-liquid in ENDS has been shown to release carcinogens such as some carbonyl and volatile organic compounds ie formaldehyde acetaldehyde and acrolein Some devices might also release heavy metals such as cadmium lead and mercury The source of such metals may be the metal of the device or the e-liquids Although unexpected from the composition of the e-liquids some studies have also detected tobacco-specific nitrosamines TNSAs N-nitrosonornicotine NNN and 4-methylnitrosoamino-1-3-pyridyl-1-butanone NNK and polycyclic aromatic hydrocarbons PAHs 1- and 2-Naphtol and 1-hydroxypyrene 1-OHP
This study will therefore test the efficacy of ENDS for cigarette smoking cessation the safety of ENDS on adverse events and the effect of ENDS on health-related outcomes and exposure to inhaled chemicals
For the main ESTxENDS trial NCT03589989 cigarette smokers motivated to quit smoking cigarettes will be included Participants in the intervention group will receive an ENDS and nicotine-containing e-liquids which they will be allowed to use ad libitum Additionally they will receive smoking cessation counseling Participants in the control group will receive smoking cessation counseling only All participants will be followed over a 24-month period Chemicals such as VOCs PAHs TSNAs heavy metals nicotine and nicotine degradation products will first be quantified in the aerosol produced by ENDS in laboratory conditions These chemicals and their metabolites will then be measured at baseline and at 6- 12- and 24- months follow-up in urine samples from study participants
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None