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

This study is currently recruiting participants.
Verified February 2014 by Hôpital le Vinatier
Sponsor:
Information provided by (Responsible Party):
Dr. E. Poulet, Hôpital le Vinatier
ClinicalTrials.gov Identifier:
NCT01288183
First received: January 27, 2011
Last updated: February 24, 2014
Last verified: February 2014
  Purpose

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 Intervention
Addiction
Smoking
Procedure: sham tDCS
Procedure: active tDCS

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Behavioral Impact of Prefrontal Anodal Transcranial Direct Current Stimulation on Smokers

Resource links provided by NLM:


Further study details as provided by Hôpital le Vinatier:

Primary Outcome Measures:
  • Change from baseline in the number of cigarettes consumed at the end of the week of tDCS [ Time Frame: Baseline and after the week of tDCS ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change from baseline in the number of cigarettes consumed 1 month after tDCS [ Time Frame: baseline and one month after tDCS ] [ Designated as safety issue: No ]

Estimated Enrollment: 40
Study Start Date: January 2011
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: March 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Sham Comparator: Sham-tDCS
sham transcranial direct current stimulation
Procedure: sham tDCS
sham condition as delivered by the stimulator (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 intensity of the stimulation: 2mA Duration of the stimulation: 20min 10 sessions, 2 per day
Procedure: active tDCS
anodal tDCS applied over the right DLPFC 2mA, 20minutes, 10 sessions, 2 per day

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

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01288183

Contacts
Contact: Emmanuel Poulet, MD, PhD +33437915565 emmanuel.poulet@ch-le-vinatier.fr

Locations
France
Hopital le Vinatier Recruiting
Bron, France, 69677
Contact: Emmanuel Poulet, MD, PhD         
Principal Investigator: Thierry d'Amato         
Sponsors and Collaborators
Hôpital le Vinatier
Investigators
Study Director: JEROME BRUNELIN, PhD Hopital le Vinatier
Principal Investigator: Emmanuel POULET, MD, PhD Hopital le Vinatier
  More Information

No publications provided

Responsible Party: Dr. E. Poulet, PUPH, Hôpital le Vinatier
ClinicalTrials.gov Identifier: NCT01288183     History of Changes
Other Study ID Numbers: 2010-A00180-39
Study First Received: January 27, 2011
Last Updated: February 24, 2014
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by Hôpital le Vinatier:
tobacco
smoking
tDCS
DLPFC

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

ClinicalTrials.gov processed this record on April 16, 2014