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Clinical Trials/NCT01288183
NCT01288183
Completed
Not Applicable

Behavioral Impact of Prefrontal Anodal Transcranial Direct Current Stimulation on Smokers

Hôpital le Vinatier1 site in 1 country38 target enrollmentJanuary 2011

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Addiction
Sponsor
Hôpital le Vinatier
Enrollment
38
Locations
1
Primary Endpoint
Smoking
Status
Completed
Last Updated
8 years ago

Overview

Brief Summary

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.

Detailed Description

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.

Registry
clinicaltrials.gov
Start Date
January 2011
End Date
December 2014
Last Updated
8 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Hôpital le Vinatier
Responsible Party
Principal Investigator
Principal Investigator

Dr. E. Poulet

PUPH

Hôpital le Vinatier

Eligibility Criteria

Inclusion Criteria

  • 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

Exclusion Criteria

  • 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

Outcomes

Primary Outcomes

Smoking

Time Frame: Baseline (three days before starting tDCS regimen) to one-month after

Self-reported number of cigarettes smoked each day

Secondary Outcomes

  • 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))

Study Sites (1)

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