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

NCT ID: NCT01288183

Last Updated: 2018-01-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 38 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-01-31
• Study Completion Date: 2014-12-31

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.

Conditions

Addiction; Smoking

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

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

Group Type: SHAM_COMPARATOR

sham tDCS

Intervention Type: 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

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

Group Type: ACTIVE_COMPARATOR

active tDCS

Intervention Type: PROCEDURE

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

Interventions

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

Intervention Type: PROCEDURE

active tDCS

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

Intervention Type: PROCEDURE

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Hôpital le Vinatier

OTHER

Sponsor Role: lead

Responsible Party

Dr. E. Poulet

PUPH

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

JEROME BRUNELIN, PhD

Role: STUDY_DIRECTOR

Hopital le Vinatier

Emmanuel POULET, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Hopital le Vinatier

Locations

Hopital le Vinatier

Bron, , France

Countries

France

Other Identifiers

2010-A00180-39

Identifier Type: -

Identifier Source: org_study_id