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| ID | Type | Description | Link |
|---|---|---|---|
| AOL 2012 | Other Identifier | Toulouse University Hospital |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Real tDCS | Experimental | Direct transcranial electrical stimulation (tDCS procedure) |
|
| Placebo tDCS | Sham Comparator | Sham procedure |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| tDCS procedure | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Relative change of individual salivary cotinine. | Outcome measure is assessed at Day1 and Day5 |
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Rose-Marie ROUQUET, MD | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospital, Toulouse | Toulouse | Midi-Pyrénées | 31059 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Background | Organisation Mondiale de la Santé. Rapport de l'OMS sur l'épidémie mondiale de tabagisme 2011, résumé d'orientation. OMS 2011 | ||
| Background | Rapport OMS Mpower 2008. | ||
| Background | Observatoire français des drogues et des toxicomanies. Les niveaux d'usage des drogues en France en 2010. OFDT Tendances, n°76, juin 2011 | ||
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| Background | Hill C, Jougla E, Beck F. Le point sur l'épidémie de cancer du poumon dû au tabagisme. BEH mai 2010; 19-20: 210-213 |
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| ID | Term |
|---|---|
| D014029 | Tobacco Use Disorder |
| D064424 | Tobacco Use |
| ID | Term |
|---|---|
| D019966 | Substance-Related Disorders |
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
| D001519 | Behavior |
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| Sham procedure | Device | 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. |
|
| 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. |
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