Clinical trial NCT01930422: Effect of Transcranial Direct Current Stimulation (tDCS) on Tobacco Consumption
Official title: Effect of Transcranial Direct Current Stimulation (tDCS) on Tobacco Consumption.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Tobacco Use Disorder
Keywords: Direct transcranial electrical stimulation (tDCS)
Sham procedure
Tobacco consumption
Craving
Lead sponsor: University Hospital, Toulouse
Sponsor class: OTHER
First posted: 2013-08-29
Enrollment: 34
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Relative change of individual salivary cotinine.
timeFrame: Outcome measure is assessed at Day1 and Day5
Secondary outcomes:
measure: Relative change of individual salivary cotinine
timeFrame: Outcome measure is assessed at Day5 and between Day15 and Day20.
measure: Exhaled carbon monoxide.
timeFrame: Outcome measure is assessed at day 0, day 1, day 2, day 3, day 4, day 5 and between day 15 and day 20.
measure: Number of cigarettes smoked per day
timeFrame: Outcome measure is assessed at day 0, day1, day2, day3, day4, day5 and between day 15 and 20
measure: Technical feasibility of outpatient
timeFrame: Outcome measure is assessed between day 15 and 20.
measure: Measurement of craving
timeFrame: Outcome measure is assessed at Day1, day2, day3, day4, day5 and betwenn day 15 to day 20.
Other outcomes:
Locations:
city: Toulouse
country: France
facility: University Hospital, Toulouse
state: Midi-Pyrénées
Study officials:
name: Rose-Marie ROUQUET, MD
role: PRINCIPAL_INVESTIGATOR
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