Clinical trial NCT01288183: Anodal Transcranial Direct Current Stimulation (tDCS) in the Treatment of Tobacco Addiction
Official title: Behavioral Impact of Prefrontal Anodal Transcranial Direct Current Stimulation on Smokers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Addiction
Smoking
Keywords: tobacco
smoking
tDCS
DLPFC
Lead sponsor: Hôpital le Vinatier
Sponsor class: OTHER
First posted: 2011-02-02
Enrollment: 38
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Smoking
timeFrame: Baseline (three days before starting tDCS regimen) to one-month after
Secondary outcomes:
measure: Exhaled carbon monoxide
timeFrame: Baseline, one-week (after the last tDCS session) and one-month later
measure: Craving
timeFrame: For each of the 10 tDCS sessions: Baseline and 0 hour post-tDCS (immediately after)
measure: fMRI brain reactivity during a smoking cue-reactivity task
timeFrame: Baseline and one-week (after the last tDCS session)
Other outcomes:
Locations:
city: Bron
country: France
facility: Hopital le Vinatier
Study officials:
affiliation: Hopital le Vinatier
name: JEROME BRUNELIN, PhD
role: STUDY_DIRECTOR
affiliation: Hopital le Vinatier
name: Emmanuel POULET, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: