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

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

Study Description

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 Design

• 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

Arms and Interventions

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

Outcome Measures

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

Eligibility Criteria

• 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

Contacts and Locations

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

More Information

• Responsible Party: Dr. E. Poulet, PUPH, Hôpital le Vinatier
• ClinicalTrials.gov Identifier: NCT01288183
• Other Study ID Numbers: 2010-A00180-39
• First Posted: February 2, 2011
• 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