The ESTxENDS Trial- Substudy on the Effect on Toxins From Using Electronic Nicotine Delivery Systems (ENDS/Vaporizer/E-cig)

Not Applicable

Completed

• Conditions: Toxicity; Smoking Cessation
• Interventions: Other: ENDS (Vaporizer/e-cig) and smoking cessation counseling; Other: Smoking cessation counseling

• Registration Number: NCT03612544
• Lead Sponsor: University of Bern

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 (i.e., 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

Not available

Study Timeline

• Study First Submitted: 2018-07-02
• Study Start: 2018-07-16
• Study First Submitted QC: 2018-07-26
• Study First Posted: 2018-08-02
• Primary Completion: 2023-08-31
• Study Completion: 2023-08-31
• Status Verified: 2023-11
• Last Update Submitted: 2023-11-13
• Last Update Posted: 2023-11-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1246

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention group	ENDS (Vaporizer/e-cig) and smoking cessation counseling	-
Control group	Smoking cessation counseling	-

Primary Outcome Measures

Name	Time	Method
Concentrations of urinary metabolites of VOCs (volatile organic compounds)_3	24 months post quit date	Measurements of metabolites of VOCs in urine
Concentrations of urinary PAHs (Polycyclic aromatic hydrocarbons)_3	24 months post quit date	Measurement of PAHs (Polycyclic aromatic hydrocarbons) in urine
Concentrations of urinary NNAL (4-(Methylnitrosamino)-1-(3-pyridyl)-1-butanol)_1	6 months post quit date	Measurement of NNAL (4-(Methylnitrosamino)-1-(3-pyridyl)-1-butanol) in urine
Concentrations of urinary NNN (N-nitrosonornicotine)_1	6 months post quit date	Measurement of NNN (N-nitrosonornicotine) in urine
Concentrations of urinary NNN (N-nitrosonornicotine)_2	12 months post quit date	Measurement of NNN (N-nitrosonornicotine) in urine
Concentrations of urinary metabolites of VOCs (volatile organic compounds)_2	12 months post quit date	Measurements of metabolites of VOCs in urine
Concentrations of urinary nicotine metabolites_1	6 months post quit date	Measurement of nicotine metabolites in urine
Concentrations of urinary PAHs (Polycyclic aromatic hydrocarbons)_1	6 months post quit date	Measurement of PAHs (Polycyclic aromatic hydrocarbons) in urine
Concentrations of urinary nicotine metabolites_2	12 months post quit date	Measurement of nicotine metabolites in urine
Concentrations of urinary NNAL (4-(Methylnitrosamino)-1-(3-pyridyl)-1-butanol)_3	24 months post quit date	Measurement of NNAL (4-(Methylnitrosamino)-1-(3-pyridyl)-1-butanol) in urine
Concentrations of urinary NNK (nicotine-derived nitrosamine ketone)_2	12 months post quit date	Measurement of NNK (nicotine-derived nitrosamine ketone) in urine
Concentrations of urinary metabolites of VOCs (volatile organic compounds)_1	6 months post quit date	Measurements of metabolites of VOCs in urine
Concentrations of urinary NNAL (4-(Methylnitrosamino)-1-(3-pyridyl)-1-butanol)_2	12 months post quit date	Measurement of NNAL (4-(Methylnitrosamino)-1-(3-pyridyl)-1-butanol) in urine
Concentrations of urinary NNN (N-nitrosonornicotine)_3	24 months post quit date	Measurement of NNN (N-nitrosonornicotine) in urine
Concentrations of urinary NNK (nicotine-derived nitrosamine ketone)_1	6 months post quit date	Measurement of NNK (nicotine-derived nitrosamine ketone) in urine
Concentrations of urinary NNK (nicotine-derived nitrosamine ketone)_3	24 months post quit date	Measurement of NNK (nicotine-derived nitrosamine ketone) in urine
Concentrations of urinary PAHs (Polycyclic aromatic hydrocarbons)_2	12 months post quit date	Measurement of PAHs (Polycyclic aromatic hydrocarbons) in urine
Concentrations of urinary heavy metals_1	6 months post quit date	Measurement of heavy metals in urine
Concentrations of urinary heavy metals_2	12 months post quit date	Measurement of heavy metals in urine
Concentrations of urinary heavy metals_3	24 months post quit date	Measurement of heavy metals in urine
Concentrations of urinary nicotine metabolites_3	24 months post quit date	Measurement of nicotine metabolites in urine

Secondary Outcome Measures

Name	Time	Method
Change in concentrations of urinary PAHs (Polycyclic aromatic hydrocarbons)	Change from baseline to 6,12, 24 months post quit date	Change of PAHs (Polycyclic aromatic hydrocarbons) concentrations in urine from baseline to 6, 12, and 24 months post quit date.
Change in concentrations of urinary heavy metals	Change from baseline to 6,12, 24 months post quit date	Change of heavy metals concentrations in urine from baseline to 6, 12, and 24 months post quit date.
Change in concentrations of urinary NNN (N-nitrosonornicotine)	Change from baseline to 6,12, 24 months post quit date	Change of NNN (N-nitrosonornicotine) concentrations in urine from baseline to 6, 12, and 24 months post quit date.
Change in concentrations of urinary NNK (nicotine-derived nitrosamine ketone)	Change from baseline to 6,12, 24 months post quit date	Change of NNK (nicotine-derived nitrosamine ketone) concentrations in urine from baseline to 6, 12, and 24 months post quit date.
Change in concentrations of urinary nicotine metabolites	Change from baseline to 6,12, 24 months post quit date	Change of nicotine metabolites concentrations in urine from baseline to 6, 12, and 24 months post quit date.
Change in concentrations of urinary NNAL (4-(Methylnitrosamino)-1-(3-pyridyl)-1-butanol)	Change from baseline to 6,12, 24 months post quit date	Change of NNAL (4-(Methylnitrosamino)-1-(3-pyridyl)-1-butanol) concentrations in urine from baseline to 6, 12, and 24 months post quit date.
Change in concentrations of urinary VOCs (volatile organic compounds)	Change from baseline to 6,12, 24 months post quit date	Change of VOCs (volatile organic compounds) concentrations in urine from baseline to 6, 12, and 24 months post quit date.

Trial Locations

Locations (5)

Epidemiology, Biostatistics and Prevention Institute (EBPI), University of Zurich; 🇨🇭 Zürich, Switzerland

University Clinic for General Internal Medicine, Bern University Hospital; 🇨🇭 Bern, Switzerland

Unisanté, Centre universitaire de médecine générale et santé publique, Université de Lausanne; 🇨🇭 Lausanne, Vaud, Switzerland

Lungenzentrum, Klinik für Pneumologie und Schlafmedizin, Kantonsspital St. Gallen; 🇨🇭 Saint Gallen, Switzerland

Département de médecine interne, Hôpitaux universitaires de Genève; 🇨🇭 Geneva, Switzerland