Effect of Transcranial Direct Current Stimulation (tDCS) on Tobacco Consumption.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 34
- 试验地点
- 2
- 主要终点
- Relative change of individual salivary cotinine.
研究概览
简要总结
The primary purpose of the protocol is to evaluate the effect of repeated application for 5 consecutive days of a real tDCS compared to the application of a placebo tDCS (sham procedure) on the evolution of tobacco consumption in the short term between Day 1 and Day 5.
The study hypothesis is that a repeated application for 5 consecutive days of a real tDCS on the left dorsolateral prefrontal cortex region will reduce the craving induced causing a decreased of daily tobacco consumption between Day 1 and Day 5 which can persist at the final visit between Day 15 and Day 20.
详细描述
Smoking is a major public health problem and it is the leading cause of preventable death in the world. Care should include education, psychotherapy and treatments, but despite these therapeutics, the smoking cessation process is often characterized by relapses. The main risk factor for relapse is craving. Neurophysiological studies have provided evidence in the understanding of craving. This craving involves surface structures including the dorsolateral prefrontal cortex, accessible by neurostimulation. Repetitive neurostimulation applies on this structures involved in craving could therefore modulate it. Two non-invasive stimulation techniques exist: repetitive transcranial magnetic stimulation (rTMS) and transcranial direct current stimulation (tDCS). The choice of tDCS is based on its ease of use, excellent tolerance, its better quality of placebo and low cost.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged 18 to 60 years old
- •Smoking ≥ 5 years
- •Smoking ≥ 15 manufactured cigarettes per day or ≥ 10 rolled cigarettes per day
- •Fagerström test ≥ 5
- •Smokers who have at least an attempt to stop of minimum 7 days
- •Written informed consent signed by the patient
- •Affiliated to medical insurance
排除标准
- •Co-addiction (cannabis, alcohol, other drugs)
- •HAD test: D ≥ 8; A + D ≥ 19
- •Treatment by nicotine replacement therapy, bupropion or varenicline within 30 days prior inclusion
- •Neuropsychiatric disease, considered serious by the investigator
- •Psychotropic treatment (antidepressant, anxiolytic, antipsychotic)
- •Skin scalp dermatosis
- •Pregnancy or breastfeeding. Positive pregnancy test.
- •Patient under guardianship, trusteeship or judicial protection
- •Patient in inclusion period for another clinical research protocol
结局指标
主要结局
Relative change of individual salivary cotinine.
时间窗: Outcome measure is assessed at Day1 and Day5
次要结局
- Relative change of individual salivary cotinine(Outcome measure is assessed at Day5 and between Day15 and Day20.)
- Exhaled carbon monoxide.(Outcome measure is assessed at day 0, day 1, day 2, day 3, day 4, day 5 and between day 15 and day 20.)
- Number of cigarettes smoked per day(Outcome measure is assessed at day 0, day1, day2, day3, day4, day5 and between day 15 and 20)
- Technical feasibility of outpatient(Outcome measure is assessed between day 15 and 20.)
- Measurement of craving(Outcome measure is assessed at Day1, day2, day3, day4, day5 and betwenn day 15 to day 20.)