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

Behavioral Impact of Prefrontal Anodal Transcranial Direct Current Stimulation on 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 and constitute a treatment of tobacco addiction.

Study Overview

• Status: Completed
• Conditions: Smoking; Addiction
• Intervention / Treatment: Procedure: sham tDCS; Procedure: active tDCS

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
• Enrollment (Actual): 38
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Bron, France, 69677
    • Hopital Le Vinatier

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Exhaled carbon monoxide	measured using a CO monitor (MicroCo, Milford, MA, USA).	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	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	Baseline and one-week (after the last tDCS session)

Collaborators and Investigators

• Sponsor: Hôpital le Vinatier

Study record dates

Study Major Dates

• Study Start: January 1, 2011
• Primary Completion (Actual): December 1, 2014
• Study Completion (Actual): December 1, 2014

Study Registration Dates

• First Submitted: January 27, 2011
• First Submitted That Met QC Criteria: February 1, 2011
• First Posted (Estimate): February 2, 2011

Study Record Updates

• Last Update Posted (Actual): January 26, 2018
• Last Update Submitted That Met QC Criteria: January 24, 2018
• Last Verified: January 1, 2018

More Information

Terms related to this study

• Keywords: tDCS; smoking; tobacco; DLPFC
• Additional Relevant MeSH Terms: Compulsive Behavior; Impulsive Behavior; Behavior, Addictive
• Other Study ID Numbers: 2010-A00180-39