Effect of Transcranial Direct Current Stimulation (tDCS) on Tobacco Consumption

Study Overview
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Brief Summary
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The primary purpose of the protocol is to evaluate the effect of repeated application for 5 consecutive days of a real tDCS compared to the application of a placebo tDCS (sham procedure) on the evolution of tobacco consumption in the short term between Day 1 and Day 5. The study hypothesis is that a repeated application for 5 consecutive days of a real tDCS on the left dorsolateral prefrontal cortex region will reduce the craving induced causing a decreased of daily tobacco consumption between Day 1 and Day 5 which can persist at the final visit between Day 15 and Day 20.

Detailed Description
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Smoking is a major public health problem and it is the leading cause of preventable death in the world. Care should include education, psychotherapy and treatments, but despite these therapeutics, the smoking cessation process is often characterized by relapses. The main risk factor for relapse is craving. Neurophysiological studies have provided evidence in the understanding of craving. This craving involves surface structures including the dorsolateral prefrontal cortex, accessible by neurostimulation. Repetitive neurostimulation applies on this structures involved in craving could therefore modulate it. Two non-invasive stimulation techniques exist: repetitive transcranial magnetic stimulation (rTMS) and transcranial direct current stimulation (tDCS). The choice of tDCS is based on its ease of use, excellent tolerance, its better quality of placebo and low cost.

Official Title
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Effect of Transcranial Direct Current Stimulation (tDCS) on Tobacco Consumption.

Conditions
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Tobacco Use Disorder

Intervention / Treatment
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* Device: tDCS procedure
* Device: Sham procedure


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Aged 18 to 60 years old Smoking ≥ 5 years Smoking ≥ 15 manufactured cigarettes per day or ≥ 10 rolled cigarettes per day Fagerström test ≥ 5 Smokers who have at least an attempt to stop of minimum 7 days Written informed consent signed by the patient Affiliated to medical insurance Exclusion Criteria: Co-addiction (cannabis, alcohol, other drugs) HAD test: D ≥ 8; A + D ≥ 19 Treatment by nicotine replacement therapy, bupropion or varenicline within 30 days prior inclusion Neuropsychiatric disease, considered serious by the investigator Psychotropic treatment (antidepressant, anxiolytic, antipsychotic) Skin scalp dermatosis Pregnancy or breastfeeding. Positive pregnancy test. Patient under guardianship, trusteeship or judicial protection Patient in inclusion period for another clinical research protocol

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Real tDCS<br>Direct transcranial electrical stimulation (tDCS procedure) | Device: tDCS procedure<br>* The tDCS is a non-invasive neuromodulation method. A stimulator delivers a constant current of low intensity (1-2 mA) applied to the average of two bipolar electrodes placed on the scalp for 20 minutes. This constant current generates a static electric field that selectively modulates the activity of cortical neurones. A tingling sensation under the electrodes appears at the beginning and at the end of stimulation but it is transient and disappears quickly in 30 or 60 seconds.<br>|
| Sham Comparator: Placebo tDCS<br>Sham procedure | Device: Sham procedure<br>* The tDCS placebo differs from the real tDCS by the interruption of stimulation after 30 to 60 seconds and reactivation of this stimulation 30 to 60 seconds before the end of the session, which lasted 20 minutes. The tingling felt at the beginning and the end of the session will be the same as those experienced with real stimulation. The electrodes establishment does not differ with respect to tDCS.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Relative change of individual salivary cotinine. |  | Outcome measure is assessed at Day1 and Day5 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Relative change of individual salivary cotinine |  | Outcome measure is assessed at Day5 and between Day15 and Day20. | 
| Exhaled carbon monoxide. |  | Outcome measure is assessed at day 0, day 1, day 2, day 3, day 4, day 5 and between day 15 and day 20. | 
| Number of cigarettes smoked per day |  | Outcome measure is assessed at day 0, day1, day2, day3, day4, day5 and between day 15 and 20 | 
| Technical feasibility of outpatient | The feasibility is assessed by the number of smokers following the entire protocol. | Outcome measure is assessed between day 15 and 20. | 
| Measurement of craving | Measurement of craving from Day1 to Day5 and at the final visits assessed by a VAS: visual analogue scale from 0 (no urge to smoke at all) to 10 (intense desire compelling smoking) and the questionnaire called the 12-item French Tobacco Craving Questionnaire (FCTQ-12). | Outcome measure is assessed at Day1, day2, day3, day4, day5 and betwenn day 15 to day 20. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Direct transcranial electrical stimulation (tDCS), Sham procedure, Tobacco consumption, Craving