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Effect of the Transcranial Direct Current Stimulation (tDCS) on Dependent Smoking People

Not Applicable
Conditions
Tobacco Abuse Smoke
Registration Number
NCT02867514
Lead Sponsor
Centre Hospitalier Universitaire de Besancon
Brief Summary

The purpose of this study is to evaluate the effect of 10 sessions of anodal transcranial Direct Current Stimulation (tDCS - 1 mA) applied to left vs right CDLPF of tobacco-dependent subjects compared to the application of a placebo tDCS (sham procedure) on the craving, which is evaluated by the item 1 of Fagerström test between day 1 and day 10. Craving is also evaluated 1 month post-treatment.

Detailed Description

Tobacco is the second leading cause of death worldwide. It is currently responsible for the death of one in 10 adults (about 5 million deaths per year) and it is the fourth disease risk factor in the world. Many methods to quit smoking are available but in all cases, relapse is a common phenomena. The main risk factor for relapse is craving. So, acting on the craving seems essential to modulate tobacco consumption. Many functional neuroimaging studies have established a neuroanatomical substrate for craving process, in particularly dorsolateral prefrontal cortex (DLPFC), accessible par neuromodulation.

Recruitment & Eligibility

Status
UNKNOWN
Sex
All
Target Recruitment
100
Inclusion Criteria
  • Fagerström score ≥ 5
  • Q-MAT score ≥ 6
  • smoking subjects from 10 to 30 cigarettes a day
  • right-handed subjects
  • w/o severe progressive somatic pathology (especially tumor diseases, degenerative diseases)
  • Hamilton Depression Rating Scale-17 score <18
Exclusion Criteria
  • pregnancy and/or lactation
  • presence of a specific contraindication for tDCS (e.g. personal history of epilepsy, metallic head implant, cardiac pacemaker...)

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Primary Outcome Measures
NameTimeMethod
change from baseline in craving evaluated by item 1 of Fagerström testbaseline, day 10 and 1 month post-ttt

before and after the 10 sessions

Secondary Outcome Measures
NameTimeMethod

Trial Locations

Locations (2)

CHRU Besancon - Service de Psychiatrie - Centre Investigation Clinique Innovation Technologique (CIC-IT808)

🇫🇷

Besancon, France

Assistance Publique - Hôpitaux de Paris

🇫🇷

Paris, France

CHRU Besancon - Service de Psychiatrie - Centre Investigation Clinique Innovation Technologique (CIC-IT808)
🇫🇷Besancon, France
Emmanuel HAFFEN, MD PhD
Principal Investigator
Magali NICOLIER, PhD
Contact
+33381219007
mnicolier@chu-besancon.fr

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