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

Smoking Clinical Trial

Official title:

Behavioral Impact of Prefrontal Anodal Transcranial Direct Current Stimulation on Smokers

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01288183
• Other study ID #: 2010-A00180-39
• Status: Completed
• Phase: N/A
• First received: January 27, 2011
• Last updated: January 24, 2018
• Start date: January 2011
• Est. completion date: December 2014

Study information

• Verified date: January 2018
• Source: Hôpital le Vinatier
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 38
• Est. completion date: December 2014
• Est. primary completion date: December 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

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

Related Conditions & MeSH terms

• Addiction
• Behavior, Addictive
• Smoking

Intervention

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

Locations

Country	Name	City	State
France	Hopital le Vinatier	Bron

Sponsors (1)

Lead Sponsor	Collaborator
Hôpital le Vinatier

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Smoking	Self-reported number of cigarettes smoked each day	Baseline (three days before starting tDCS regimen) to one-month after
Secondary	Exhaled carbon monoxide	measured using a CO monitor (MicroCo, Milford, MA, USA).	Baseline, one-week (after the last tDCS session) and one-month later
Secondary	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)
Secondary	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)