Anodal Transcranial Direct Current Stimulation (tDCS) in the Treatment of Tobacco Addiction

Hôpital le Vinatier38 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Addiction Smoking

Interventions

sham tDCSPROCEDURE

sham condition as delivered by the stimulator "study mode" (2mA during 40s and brief current pulses until the end of the stimulation) 20 minutes, 10 sessions, 2 per day

active tDCSPROCEDURE

anodal tDCS applied over the right DLPFC 2mA, 20minutes, 10 sessions, 2 per day

Eligibility

Sex: ALLMin age: 18 YearsMax age: 55 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Hopital le Vinatier

Bron, France

Outcomes

Primary Outcomes

Smoking

Self-reported number of cigarettes smoked each day

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

Secondary Outcomes

Exhaled carbon monoxide

measured using a CO monitor (MicroCo, Milford, MA, USA).

Time frame: Baseline, one-week (after the last tDCS session) and one-month later

Craving

measured using a 5-item Likert-type scale questionnaire of smoking urge

Time frame: For each of the 10 tDCS sessions: Baseline and 0 hour post-tDCS (immediately after)

fMRI brain reactivity during a smoking cue-reactivity task

measured using an event-related fMRI paradigm

Time frame: Baseline and one-week (after the last tDCS session)

Data from ClinicalTrials.gov

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