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

Toulouse University Hospital

Status

Completed

Conditions

Tobacco Use Disorder

Treatments

Device: tDCS procedure

Device: Sham procedure

Study type

Interventional

Funder types

Other

Identifiers

NCT01930422

12 392 02

AOL 2012 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment

34 patients

Sex

All

Ages

18 to 60 years old

Volunteers

No Healthy Volunteers

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