Determination of Carcinogens Nicotine in Electronic Cigarettes Users
试验速览
- 阶段
- 不适用
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- NNN urinary concentrations obtained in the group "electronic cigarette" versus group "nocotine replacement treatment".
研究概览
简要总结
Multicenter, national study, non-randomized , controlled, comparative with 4 independent groups (20 participants in each group). There are 3 experimental groups ("smocker", "nicotine replacement therapy" an "electronic cigarette") and 1 control group ("without nicotine").
The main objective of the study is to compare the level of urinary NNN in the electronic cigarette users versus the nicotine replacement therapy (patch) users.
详细描述
The study has only one visit taking place as below:
- Verification of inclusion and non-inclusion criteria.
- Collection of the informed consent of the subject Given the non-invasive nature of the procedure, a period of reflection will be given to the subjects, however, information and obtaining consent will be made during the same visit.
- Collection of 5 mL of required for the pregnancy test in women of childbearing age. This collection does not need to be fasting. If this test is positive, the subject will not be included in the study.
- Collection of 30 mL of urine needed for the cotinine and the NNN quantitative analysis.
This collection does not need to be fasting.
Then , the urine sample is divided into two vials stored at -80 ° C:
- a 10 mL vial for the cotinine analysis,
- a 20 mL vial for the NNN analysis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
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
- •Adults (18 years old and more)
- •Exclusive daily smoker for more than 4 weeks, consuming 10 manufactured cigarettes per day or more
- •With health insurance
- •Adults (18 years old and more)
- •Users of electronic cigarette EGO or MOD type for 4 weeks or more
- •Using a nicotine dosage of 12mg / ml or more for at least 4 weeks
- •Former smokers who consumed 10 cigarettes per day or more
- •Having completely stopped smoking for at least 4 weeks
- •No Subjected to passive smoking (verified by measuring carbon monoxide in exhaled air)
- •With health insurance
- •Adults (18 years old and more)
- •People in patch 21 mg / 24h or 25mg / 16h in the fourth week or more treatment
- •Without taking oral nicotine or electronic cigarette for at least 4 weeks
- •Not subject to passive smoking (verified by measuring carbon monoxide in exhaled air)
- •Former smokers who consumed 10 cigarettes per day or more
- •Having completely stopped smoking for at least 4 weeks
- •With health insurance
- •Group 4 (control group):
- •Adults (18 years old and more)
- •People Non-smoking, non-users of electronic cigarette, non-users of nicotine replacement therapy for at least 4 weeks
- •Not subject to passive smoking (verified by measuring carbon monoxide in exhaled air)
- •With health insurance
- •Patients in Groups 1, 2 and 3 must have a urinary cotinine ≥ 100 (ratio cotinine / creatinine - Determination Cotinine DRI). Patients in group 4 must have a urinary cotinine ≤ 10 (cotinine / creatinine ratio - Determination Cotinine DRI)
- •The thresholds of carbon monoxide from clinical experience are:
- •Non current smoker: 0 to 5 parts per million (ppm)
- •Passive smoker: 6 to 9 ppm
- •Current active smoker : 10 ppm or more
- •Non inclusion criteria
- •Rolling tobacco, cigars, cigarillos, pipe, bidi, chicha, cannabis smockers during the last 4 weeks
- •Users tobacco snuff or chewing tobacco during the last 4 weeks
- •Users of oral nicotine replacement therapy (gum, lozenges, inhalers, oral spray) during the last 4 weeks.
- •Users of drug for smoking cessation aid other than nicotinic treatment: Varenicline, Bupropion, clonidine, Cytisine during the last 4 weeks
- •Pregnant or breastfeeding women
- •Non-compliant or unable to follow directions
- •Refusing to sign the informed consent
- •Refusing to do the urine collection
- •Under guardianship or any other protective measures
排除标准
- •Group 1, 2 and 3:
- •Having an urinary cotinine <100 (ratio cotinine / creatinine - Determination Cotinine DRI)
- •Group 4 (control group):
- •Having an urinary cotinine> 10 (ratio cotinine / creatinine - Determination Cotinine DRI)
- •The determination of urinary cotinine levels will be carried out centrally. The result will not be available at the inclusion visit. The included patients who do not have the urinary cotinine levels required for their group, will secondarily excluded from the study.
- •The number of subjects in Groups 1, 2 and 3 with a ratio of cotinine would be less than 100 is expected to be negligible.A102
研究组 & 干预措施
Smocker
Cigarette consumption in the context of their habit (not related to the particiapion under study).
干预措施: pregnancy test (Biological)
Smocker
Cigarette consumption in the context of their habit (not related to the particiapion under study).
干预措施: Urinary NNN assesement (Biological)
Electronic cigarette
Electronic cigarette consumption in the context of their habit (not related to the particiapion under study).
干预措施: pregnancy test (Biological)
Electronic cigarette
Electronic cigarette consumption in the context of their habit (not related to the particiapion under study).
干预措施: urinary cotinine assesment (Biological)
Electronic cigarette
Electronic cigarette consumption in the context of their habit (not related to the particiapion under study).
干预措施: Urinary NNN assesement (Biological)
Electronic cigarette
Electronic cigarette consumption in the context of their habit (not related to the particiapion under study).
干预措施: Questionnaire (Fagerstrom test) (Behavioral)
Electronic cigarette
Electronic cigarette consumption in the context of their habit (not related to the particiapion under study).
干预措施: Measurement of carbon monoxide levels expired (Procedure)
Nicotine replacement therapy
Nicotine replacement therapy (only patch) consumption in the context of their habit (not related to the particiapion under study).
干预措施: pregnancy test (Biological)
Nicotine replacement therapy
Nicotine replacement therapy (only patch) consumption in the context of their habit (not related to the particiapion under study).
干预措施: Urinary NNN assesement (Biological)
Without nicotine
No consumption in the context of their habit (not related to the particiapion under study).
干预措施: pregnancy test (Biological)
Without nicotine
No consumption in the context of their habit (not related to the particiapion under study).
干预措施: urinary cotinine assesment (Biological)
Without nicotine
No consumption in the context of their habit (not related to the particiapion under study).
干预措施: Urinary NNN assesement (Biological)
Without nicotine
No consumption in the context of their habit (not related to the particiapion under study).
干预措施: Questionnaire (Fagerstrom test) (Behavioral)
Without nicotine
No consumption in the context of their habit (not related to the particiapion under study).
干预措施: Measurement of carbon monoxide levels expired (Procedure)
结局指标
主要结局
NNN urinary concentrations obtained in the group "electronic cigarette" versus group "nocotine replacement treatment".
时间窗: At the inclusion
The determination of urinary NNN of will be performed at the end of the study only for subjects with cotinine / creatinine ratio adequate.
次要结局
- NNN urinary concentrations obtained in the group "electronic cigarette" versus group "no consumption of nicotine"(At the inclusion)
- NNN urinary concentrations obtained in the group "nicotine replacement treatment" versus "no consumption of nicotine"(At the inclusion)
- NNN urinary concentrations obtained in the group "nicotine replacement treatment" versus group "smocker"(At the inclusion)
- NNN urinary concentrations obtained in the group "electronic cigarette" versus group "smocker"(At the inclusion)