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Completed

NCT Number: NCT01288183

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

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.

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Key information

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hopital le Vinatier

Bron, 69677, France

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Sham tDCS

Procedure

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 tDCS

Procedure

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

Primary outcomes

  1. Smoking

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

    Self-reported number of cigarettes smoked each day

Secondary outcomes

  1. Exhaled carbon monoxide

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

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

  2. Craving

    Time frame: 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

  3. fMRI brain reactivity during a smoking cue-reactivity task

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

    measured using an event-related fMRI paradigm

Sponsors and collaborators

Lead sponsor

Hôpital le Vinatier

Other

Registry information

Official study title

Behavioral Impact of Prefrontal Anodal Transcranial Direct Current Stimulation on Smokers

Important dates

Study start
2011
Primary completion
2014
Study completion
2014
First posted
Feb 2, 2011
Registry last updated
Jan 26, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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