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

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ClinicalTrials.gov Identifier: NCT01288183
Recruitment Status : Completed
First Posted : February 2, 2011
Last Update Posted : January 26, 2018
Sponsor:
Information provided by (Responsible Party):
Dr. E. Poulet, 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.

Condition or disease Intervention/treatment Phase
Addiction Smoking Procedure: sham tDCS Procedure: active tDCS Not Applicable

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 Type : Interventional  (Clinical Trial)
Actual Enrollment : 38 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Behavioral Impact of Prefrontal Anodal Transcranial Direct Current Stimulation on Smokers
Study Start Date : January 2011
Actual Primary Completion Date : December 2014
Actual Study Completion Date : December 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Smoking

Arm Intervention/treatment
Sham Comparator: sham tDCS
sham transcranial direct current stimulation The anode (7 x 5 cm) is placed on the right dorsolateral prefrontal cortex. A large cathode (10 x 10cm) is placed on the left occipital region
Procedure: sham tDCS
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 Comparator: active tDCS
active anodal tDCS over the right dorsolateral prefrontal cortex The anode (7 x 5 cm) is placed on the right dorsolateral prefrontal cortex. A large cathode (10 x 10cm) is placed on the left occipital region Intensity of the stimulation: 2 mA Duration of the stimulation: 20 min 10 sessions, 2 per day
Procedure: active tDCS
anodal tDCS applied over the right DLPFC 2mA, 20minutes, 10 sessions, 2 per day




Primary Outcome Measures :
  1. Smoking [ Time Frame: Baseline (three days before starting tDCS regimen) to one-month after ]
    Self-reported number of cigarettes smoked each day


Secondary Outcome Measures :
  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



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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01288183


Locations
France
Hopital le Vinatier
Bron, France, 69677
Sponsors and Collaborators
Hôpital le Vinatier
Investigators
Study Director: JEROME BRUNELIN, PhD Hopital le Vinatier
Principal Investigator: Emmanuel POULET, MD, PhD Hopital le Vinatier

Responsible Party: Dr. E. Poulet, PUPH, Hôpital le Vinatier
ClinicalTrials.gov Identifier: NCT01288183     History of Changes
Other Study ID Numbers: 2010-A00180-39
First Posted: February 2, 2011    Key Record Dates
Last Update Posted: January 26, 2018
Last Verified: January 2018

Keywords provided by Dr. E. Poulet, Hôpital le Vinatier:
tobacco
smoking
tDCS
DLPFC

Additional relevant MeSH terms:
Behavior, Addictive
Compulsive Behavior
Impulsive Behavior