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临床试验/NCT01288183
NCT01288183已完成不适用

Behavioral Impact of Prefrontal Anodal Transcranial Direct Current Stimulation on Smokers

Hôpital le Vinatier2 个研究点 分布在 1 个国家目标入组 38 人开始时间: 2011年1月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
38
试验地点
2
主要终点
Smoking

研究概览

简要总结

The aim of this study is to determine whether a powerful technique of noninvasive brain stimulation, transcranial direct current stimulation (tDCS), could reduce cigarette smoking and constitute a treatment of tobacco addiction.

详细描述

Tobacco is estimated to cause more than 5 millions yearly deaths in the developed world. Although most smokers would like to quit, relapse rates remain high. It seems that this relapse is linked with the process of craving, which is a powerful desire to smoke elicited by smoking deprivation or exposure to situations or cues that are associated with smoking. Neuroimaging studies have shown that the dorsolateral prefrontal cortex (DLPFC), and especially the right part, is critically involved in processing the craving of smoking. Increasing the activity of the DLPFC by noninvasive brain stimulation has been demonstrated to be effective in decreasing craving symptoms in cigarette smokers.

The aim of this study is to determine whether a powerful technique of noninvasive brain stimulation, transcranial direct current stimulation (tDCS), could reduce cigarette smoking. tDCS is a painless and safe brain stimulation method capable of modulating cortical excitability. The nature of these modulations depends on stimulation polarity: anodal tDCS is thought to cause neuronal depolarisation and thus enhancing cortical excitability whereas cathodal stimulation is proposed to reduce excitability. The investigators hypothesize that anodal tDCS applied repetitively to the right DLPFC could constitute a treatment of tobacco addiction. Therefore, the investigators will conduct a sham-tDCS-controlled, randomized, double-blind study.

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
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 55 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Age from 18 to 55 years old
  • Tobacco consumption from 10 to 25 cigarettes, for at least 1 year
  • Strong tobacco dependence at the Fagerstrom Test (score >= 5)
  • Motivation to quit with a score >=12 at the Motivation to Quit Smoking Scale (Q-MAT)
  • Informed consent

排除标准

  • Concomitant Axe I psychiatric disorder according to the Diagnostic and Statistical Manual of Mental Disorders, 4th edition (DSM IV)
  • Other addictive disorder (DSM IV)
  • No history of smoking cessation drug the previous year
  • Psychotropic treatment
  • Pregnancy or nursing

研究组 & 干预措施

sham tDCS

Sham Comparator

sham transcranial direct current stimulation The anode (7 x 5 cm) is placed on the right dorsolateral prefrontal cortex. A large cathode (10 x 10cm) is placed on the left occipital region

干预措施: sham tDCS (Procedure)

active tDCS

Active Comparator

active anodal tDCS over the right dorsolateral prefrontal cortex The anode (7 x 5 cm) is placed on the right dorsolateral prefrontal cortex. A large cathode (10 x 10cm) is placed on the left occipital region Intensity of the stimulation: 2 mA Duration of the stimulation: 20 min 10 sessions, 2 per day

干预措施: active tDCS (Procedure)

结局指标

主要结局

Smoking

时间窗: Baseline (three days before starting tDCS regimen) to one-month after

Self-reported number of cigarettes smoked each day

次要结局

  • Exhaled carbon monoxide(Baseline, one-week (after the last tDCS session) and one-month later)
  • Craving(For each of the 10 tDCS sessions: Baseline and 0 hour post-tDCS (immediately after))
  • fMRI brain reactivity during a smoking cue-reactivity task(Baseline and one-week (after the last tDCS session))

研究者

发起方
Hôpital le Vinatier
申办方类型
Other
责任方
Principal Investigator
主要研究者

Dr. E. Poulet

PUPH

Hôpital le Vinatier

研究点 (2)

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