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

Not Applicable

Completed

• Conditions: Addiction; Smoking

• Registration Number: NCT01288183
• Lead Sponsor: Hôpital le Vinatier

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.

Study Timeline

• Study Start: 2011-01
• Study First Submitted: 2011-01-27
• Study First Submitted QC: 2011-02-01
• Study First Posted: 2011-02-02
• Primary Completion: 2014-12
• Study Completion: 2014-12
• Status Verified: 2018-01
• Last Update Submitted: 2018-01-24
• Last Update Posted: 2018-01-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 38

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Smoking	Baseline (three days before starting tDCS regimen) to one-month after	Self-reported number of cigarettes smoked each day

Secondary Outcome Measures

Name	Time	Method
Exhaled carbon monoxide	Baseline, one-week (after the last tDCS session) and one-month later	measured using a CO monitor (MicroCo, Milford, MA, USA).
Craving	For each of the 10 tDCS sessions: Baseline and 0 hour post-tDCS (immediately after)	measured using a 5-item Likert-type scale questionnaire of smoking urge
fMRI brain reactivity during a smoking cue-reactivity task	Baseline and one-week (after the last tDCS session)	measured using an event-related fMRI paradigm

Trial Locations

Locations (1)

Hopital le Vinatier; 🇫🇷 Bron, France