Electronic Cigarette and Cognitive Functioning: (CogEcig)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Cognitive Performances
研究概览
简要总结
The aim of the present study is to compare cognitive scores (attention, executive function and working memory) of different e-Cigarette strength with usual cigarettes.
详细描述
The study is randomised cross-over trial designed to compare: 1) Cognitive performances levels for four different e-Cigarette strength. Participants will be requested to abstain from smoking and alcohol from 20:00 on the night before each study day and from food and caffeine for at least 1 h before the session. On arrival at the study centre, carbon monoxide (CO) will be measured in participants' expired breath. If CO will be >15 parts per million (ppm), the assigned study treatment will be allocated; however, if CO was >15 ppm or they will report smoking in the previous 12 h, participants will be rescheduled wherever possible to a subsequent session.
On the first study day, participants will be randomised to use one of five ordered conditions: Electronic Nicotine Delivery Device (ENDD) (fourth generation) containing nicotine 2,4%; Electronic Nicotine Delivery Device (ENDD (second generation) containing nicotine 7,4 mg; Electronic Nicotine Delivery Device (ENDD containing nicotine 9 mg; Electronic Nicotine Delivery Device (ENDD nicotine free; their usual cigarette. Additionally participants will be trained to use an electronic cigarette. The following tests will be completed at the each visits: Continuous Performance Test - AX version (CPT-AX), Wisconsin card sorting test( WCST), Working memory test (N-BACK).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •20 regular smokers (smoking ≥ 15 factory-made cigarettes per day for at least the past 10 years and not currently attempting to quit smoking or wishing to do so in the next 30 days, CO > 10 parts per million ) will be recruited from the local Hospital staff in Catania, Italy.
排除标准
- •people who reported recent myocardial infarction, angina pectoris or other serious medical conditions (diabetes mellitus, severe allergies, poorly controlled asthma or other airways disease, poorly controlled psychiatric disorders or current chemical dependence other than nicotine) and
- •pregnancy,
- •breastfeeding,
- •blood pressure > 180 mm Hg systolic and/or 100 mm Hg diastolic,
- •weight < 45 or > 120 kg, or
- •current use of any other smoking cessation medications
研究组 & 干预措施
Own Brand cigarette
Smoke Own Brand cigarette, 15 puff of cigarette.
干预措施: one high 2,4% nicotine (Other)
Own Brand cigarette
Smoke Own Brand cigarette, 15 puff of cigarette.
干预措施: original 7,4 mg nicotine (Other)
Own Brand cigarette
Smoke Own Brand cigarette, 15 puff of cigarette.
干预措施: nicotine free (Other)
Own Brand cigarette
Smoke Own Brand cigarette, 15 puff of cigarette.
干预措施: Ego 9mg (Other)
One High 2,4% nicotine
Smoke electronic cigarette One High 2,4% nicotine for a day, 15 puff of e-cigarette.
干预措施: Own Brand cigarette (Other)
One High 2,4% nicotine
Smoke electronic cigarette One High 2,4% nicotine for a day, 15 puff of e-cigarette.
干预措施: original 7,4 mg nicotine (Other)
One High 2,4% nicotine
Smoke electronic cigarette One High 2,4% nicotine for a day, 15 puff of e-cigarette.
干预措施: nicotine free (Other)
One High 2,4% nicotine
Smoke electronic cigarette One High 2,4% nicotine for a day, 15 puff of e-cigarette.
干预措施: Ego 9mg (Other)
Original 7,4 mg nicotine
Smoke electronic cigarette Original 7,4 mg nicotine for a day. 15 puff of e-cigarette.
干预措施: Own Brand cigarette (Other)
Nicotine Free
Smoke electronic cigarette nicotine free (15 puff)
干预措施: Own Brand cigarette (Other)
Original 7,4 mg nicotine
Smoke electronic cigarette Original 7,4 mg nicotine for a day. 15 puff of e-cigarette.
干预措施: one high 2,4% nicotine (Other)
Original 7,4 mg nicotine
Smoke electronic cigarette Original 7,4 mg nicotine for a day. 15 puff of e-cigarette.
干预措施: nicotine free (Other)
Nicotine Free
Smoke electronic cigarette nicotine free (15 puff)
干预措施: one high 2,4% nicotine (Other)
Nicotine Free
Smoke electronic cigarette nicotine free (15 puff)
干预措施: original 7,4 mg nicotine (Other)
Nicotine Free
Smoke electronic cigarette nicotine free (15 puff)
干预措施: Ego 9mg (Other)
EGO 9mg
Smoke electronic cigarette EGO for a day (15 puff)
干预措施: Own Brand cigarette (Other)
EGO 9mg
Smoke electronic cigarette EGO for a day (15 puff)
干预措施: one high 2,4% nicotine (Other)
EGO 9mg
Smoke electronic cigarette EGO for a day (15 puff)
干预措施: original 7,4 mg nicotine (Other)
EGO 9mg
Smoke electronic cigarette EGO for a day (15 puff)
干预措施: nicotine free (Other)
结局指标
主要结局
Cognitive Performances
时间窗: 35 minutes
Compare cognitive performances in subjects who smoke "Categoria" electronic cigarettes labelled Original 7,4 mg nicotine , "Categoria" electronic cigarettes labelled One 2,4% nicotine, "Categoria" electronic cigarettes labelled "Mint" nicotine free, electronic cigarettes labelled Ego 9 mg nicotine with usual cigarettes.
次要结局
未报告次要终点
研究者
Riccardo Polosa
Professor
Universita degli Studi di Catania