Substudy of Efficacy, Safety and Toxicology of Electronic Nicotine Delivery Systems as an Aid for Smoking Cessation (ESTxENDS Trial)- the Toxins Substudy of ESTxENDS
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 1,246
- 试验地点
- 8
- 主要终点
- Concentrations of urinary nicotine metabolites_1
研究概览
简要总结
--> 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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
盲法说明
Statisticians and laboratory personnel will be blinded to group allocation.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
Concentrations of urinary nicotine metabolites_1
时间窗: 6 months post quit date
Measurement of nicotine metabolites in urine
Concentrations of urinary NNN (N-nitrosonornicotine)_1
时间窗: 6 months post quit date
Measurement of NNN (N-nitrosonornicotine) in urine
Concentrations of urinary NNN (N-nitrosonornicotine)_2
时间窗: 12 months post quit date
Measurement of NNN (N-nitrosonornicotine) in urine
Concentrations of urinary metabolites of VOCs (volatile organic compounds)_2
时间窗: 12 months post quit date
Measurements of metabolites of VOCs in urine
Concentrations of urinary metabolites of VOCs (volatile organic compounds)_3
时间窗: 24 months post quit date
Measurements of metabolites of VOCs in urine
Concentrations of urinary PAHs (Polycyclic aromatic hydrocarbons)_3
时间窗: 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
时间窗: 6 months post quit date
Measurement of NNAL (4-(Methylnitrosamino)-1-(3-pyridyl)-1-butanol) in urine
Concentrations of urinary PAHs (Polycyclic aromatic hydrocarbons)_1
时间窗: 6 months post quit date
Measurement of PAHs (Polycyclic aromatic hydrocarbons) in urine
Concentrations of urinary nicotine metabolites_2
时间窗: 12 months post quit date
Measurement of nicotine metabolites in urine
Concentrations of urinary NNAL (4-(Methylnitrosamino)-1-(3-pyridyl)-1-butanol)_3
时间窗: 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
时间窗: 12 months post quit date
Measurement of NNK (nicotine-derived nitrosamine ketone) in urine
Concentrations of urinary metabolites of VOCs (volatile organic compounds)_1
时间窗: 6 months post quit date
Measurements of metabolites of VOCs in urine
Concentrations of urinary NNAL (4-(Methylnitrosamino)-1-(3-pyridyl)-1-butanol)_2
时间窗: 12 months post quit date
Measurement of NNAL (4-(Methylnitrosamino)-1-(3-pyridyl)-1-butanol) in urine
Concentrations of urinary NNN (N-nitrosonornicotine)_3
时间窗: 24 months post quit date
Measurement of NNN (N-nitrosonornicotine) in urine
Concentrations of urinary NNK (nicotine-derived nitrosamine ketone)_1
时间窗: 6 months post quit date
Measurement of NNK (nicotine-derived nitrosamine ketone) in urine
Concentrations of urinary NNK (nicotine-derived nitrosamine ketone)_3
时间窗: 24 months post quit date
Measurement of NNK (nicotine-derived nitrosamine ketone) in urine
Concentrations of urinary PAHs (Polycyclic aromatic hydrocarbons)_2
时间窗: 12 months post quit date
Measurement of PAHs (Polycyclic aromatic hydrocarbons) in urine
Concentrations of urinary heavy metals_1
时间窗: 6 months post quit date
Measurement of heavy metals in urine
Concentrations of urinary heavy metals_2
时间窗: 12 months post quit date
Measurement of heavy metals in urine
Concentrations of urinary heavy metals_3
时间窗: 24 months post quit date
Measurement of heavy metals in urine
Concentrations of urinary nicotine metabolites_3
时间窗: 24 months post quit date
Measurement of nicotine metabolites in urine
次要结局
- Change in concentrations of urinary PAHs (Polycyclic aromatic hydrocarbons)(Change from baseline to 6,12, 24 months post quit date)
- Change in concentrations of urinary heavy metals(Change from baseline to 6,12, 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 in concentrations of urinary NNK (nicotine-derived nitrosamine ketone)(Change from baseline to 6,12, 24 months post quit date)
- Change in concentrations of urinary nicotine metabolites(Change from baseline to 6,12, 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 in concentrations of urinary VOCs (volatile organic compounds)(Change from baseline to 6,12, 24 months post quit date)