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

University of Bern1,246 enrolled

Overview

--\> 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.

Study Type

INTERVENTIONAL

Interventions

ENDS (Vaporizer/e-cig) and smoking cessation counselingOTHER

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 will be allowed to additionally use nicotine replacement therapy. All participants will be followed over a 24-month period. Smoking cessation counseling will be provided in person at the first clinical visit and then over the phone at the target quit date one week later and again at week 2, 4 and 8 after the target quit date. After 6, 12 and 24 months, participants will be asked to come to a clinical visit.

Smoking cessation counselingOTHER

Participants in the control group will receive smoking cessation counseling only. Participants will be allowed to additionally use nicotine replacement therapy. All participants will be followed over a 24-month period. Smoking cessation counseling will be provided in person at the first clinical visit and then over the phone at the target quit date one week later and again at week 2, 4 and 8 after the target quit date. After 6, 12 and 24 months, participants will be asked to come to a clinical visit.

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion criteria: * Informed Consent as documented by signature * Persons aged 18 or older * Currently smoking 5 or more cigarettes a day for at least 12 months * Willing to try to quit smoking within the next 3 months, * Persons providing a valid phone number, a valid email address and/or a valid postal address. Exclusion criteria: * Known hypersensitivity or allergy to contents of the e-liquid * Participation in another study with investigational drug within the 30 days preceding the baseline visit and during the present study where interactions are to be expected * Women who are pregnant or breast feeding * Intention to become pregnant during the course of the scheduled study intervention, i.e. within the first 6-months of the study * Persons having used ENDS or tobacco heating systems regularly in the 3 months preceding the baseline visit * Persons having used nicotine replacement therapy (NRT) or other medications with demonstrated efficacy as an aid for smoking cessation such as varenicline or bupropion within the 3 months preceding the baseline visit * Persons who cannot attend the 6- month follow-up visit for any reason * Cannot understand instructions delivered in person or by phone, or otherwise unable to participate in study procedures

Locations (5)

Unisanté, Centre universitaire de médecine générale et santé publique, Université de Lausanne

Lausanne, Canton of Vaud, Switzerland

University Clinic for General Internal Medicine, Bern University Hospital

Bern, Switzerland

Département de médecine interne, Hôpitaux universitaires de Genève

Geneva, Switzerland

Lungenzentrum, Klinik für Pneumologie und Schlafmedizin, Kantonsspital St. Gallen

Sankt Gallen, Switzerland

Epidemiology, Biostatistics and Prevention Institute (EBPI), University of Zurich

Zurich, Switzerland

Outcomes

Primary Outcomes

Concentrations of urinary NNAL (4-(Methylnitrosamino)-1-(3-pyridyl)-1-butanol)_1

Measurement of NNAL (4-(Methylnitrosamino)-1-(3-pyridyl)-1-butanol) in urine

Time frame: 6 months post quit date

Concentrations of urinary NNAL (4-(Methylnitrosamino)-1-(3-pyridyl)-1-butanol)_2

Measurement of NNAL (4-(Methylnitrosamino)-1-(3-pyridyl)-1-butanol) in urine

Time frame: 12 months post quit date

Concentrations of urinary NNAL (4-(Methylnitrosamino)-1-(3-pyridyl)-1-butanol)_3

Measurement of NNAL (4-(Methylnitrosamino)-1-(3-pyridyl)-1-butanol) in urine

Time frame: 24 months post quit date

Concentrations of urinary NNN (N-nitrosonornicotine)_1

Measurement of NNN (N-nitrosonornicotine) in urine

Time frame: 6 months post quit date

Concentrations of urinary NNN (N-nitrosonornicotine)_2

Measurement of NNN (N-nitrosonornicotine) in urine

Time frame: 12 months post quit date

Concentrations of urinary NNN (N-nitrosonornicotine)_3

Measurement of NNN (N-nitrosonornicotine) in urine

Time frame: 24 months post quit date

Concentrations of urinary NNK (nicotine-derived nitrosamine ketone)_1

Measurement of NNK (nicotine-derived nitrosamine ketone) in urine

Time frame: 6 months post quit date

Concentrations of urinary NNK (nicotine-derived nitrosamine ketone)_2

Measurement of NNK (nicotine-derived nitrosamine ketone) in urine

Time frame: 12 months post quit date

Concentrations of urinary NNK (nicotine-derived nitrosamine ketone)_3

Measurement of NNK (nicotine-derived nitrosamine ketone) in urine

Time frame: 24 months post quit date

Concentrations of urinary metabolites of VOCs (volatile organic compounds)_1

Measurements of metabolites of VOCs in urine

Time frame: 6 months post quit date

Concentrations of urinary metabolites of VOCs (volatile organic compounds)_2

Measurements of metabolites of VOCs in urine

Time frame: 12 months post quit date

Concentrations of urinary metabolites of VOCs (volatile organic compounds)_3

Measurements of metabolites of VOCs in urine

Time frame: 24 months post quit date

Concentrations of urinary PAHs (Polycyclic aromatic hydrocarbons)_1

Measurement of PAHs (Polycyclic aromatic hydrocarbons) in urine

Time frame: 6 months post quit date

Concentrations of urinary PAHs (Polycyclic aromatic hydrocarbons)_2

Measurement of PAHs (Polycyclic aromatic hydrocarbons) in urine

Time frame: 12 months post quit date

Concentrations of urinary PAHs (Polycyclic aromatic hydrocarbons)_3

Measurement of PAHs (Polycyclic aromatic hydrocarbons) in urine

Time frame: 24 months post quit date

Concentrations of urinary heavy metals_1

Measurement of heavy metals in urine

Time frame: 6 months post quit date

Concentrations of urinary heavy metals_2

Measurement of heavy metals in urine

Time frame: 12 months post quit date

Concentrations of urinary heavy metals_3

Measurement of heavy metals in urine

Time frame: 24 months post quit date

Concentrations of urinary nicotine metabolites_1

Measurement of nicotine metabolites in urine

Time frame: 6 months post quit date

Concentrations of urinary nicotine metabolites_2

Measurement of nicotine metabolites in urine

Time frame: 12 months post quit date

Concentrations of urinary nicotine metabolites_3

Measurement of nicotine metabolites in urine

Time frame: 24 months post quit date

Secondary Outcomes

Change in concentrations of urinary NNAL (4-(Methylnitrosamino)-1-(3-pyridyl)-1-butanol)

Change of NNAL (4-(Methylnitrosamino)-1-(3-pyridyl)-1-butanol) concentrations in urine from baseline to 6, 12, and 24 months post quit date.

Time frame: Change from baseline to 6,12, 24 months post quit date

Change in concentrations of urinary NNN (N-nitrosonornicotine)

Change of NNN (N-nitrosonornicotine) concentrations in urine from baseline to 6, 12, and 24 months post quit date.

Time frame: Change from baseline to 6,12, 24 months post quit date

Change in concentrations of urinary NNK (nicotine-derived nitrosamine ketone)

Change of NNK (nicotine-derived nitrosamine ketone) concentrations in urine from baseline to 6, 12, and 24 months post quit date.

Time frame: Change from baseline to 6,12, 24 months post quit date

Change in concentrations of urinary VOCs (volatile organic compounds)

Change of VOCs (volatile organic compounds) concentrations in urine from baseline to 6, 12, and 24 months post quit date.

Time frame: Change from baseline to 6,12, 24 months post quit date

Change in concentrations of urinary PAHs (Polycyclic aromatic hydrocarbons)

Change of PAHs (Polycyclic aromatic hydrocarbons) concentrations in urine from baseline to 6, 12, and 24 months post quit date.

Time frame: Change from baseline to 6,12, 24 months post quit date

Change in concentrations of urinary heavy metals

Change of heavy metals concentrations in urine from baseline to 6, 12, and 24 months post quit date.

Time frame: Change from baseline to 6,12, 24 months post quit date

Change in concentrations of urinary nicotine metabolites

Change of nicotine metabolites concentrations in urine from baseline to 6, 12, and 24 months post quit date.

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

Overview

Conditions

Interventions

Eligibility

Locations (5)

Outcomes

Primary Outcomes

Secondary Outcomes