Direct Transcranial Electrical Stimulation in Tobacco Addiction (tDCS) (tDCS)

Evaluation of the Effect of Transcranial Direct Current Stimulation (tDCS) in Nicotine-Dependent Tobacco Users

In summary, there are currently many therapeutic tools for achieving some degree of control or even cessation of tobacco addictive use. No single therapy seems to have proven itself sufficiently effective to be the preferred treatment axis in the management of this addiction. We can also point out that so far the main treatments aimed at reducing or controlling the craving phenomenon are of a pharmacological nature, thus exposing the participants to the side effects inherent to this type of treatment. In this perspective, the establishment of non invasive brain stimulation (TdCS), acting in a targeted manner on craving and whose effects would be mild and transient, appears quite justified, especially in addition to psychotherapy. In the context of the management of addictive pathologies, the choice of smoking dependence seems relevant to us insofar as this addiction represents a major public health problem.

Study Overview

• Status: Recruiting
• Conditions: Adults (Male and Female Subjects) With Tobacco Dependence
• Intervention / Treatment: Other: Transcranial Direct Current Stimulation

• Study Type: Observational
• Enrollment (Estimated): 100

Contacts and Locations

• Study Contact: Name: Florence THIBAUT, PHD; Phone Number: (33) 1 58 41 16 79; Email: florence.thibaut@aphp.fr
• Study Contact Backup: Name: Marie BENHAMMANI-GODARD; Phone Number: (33) 1 58 41 11 90; Email: marie.godard@aphp.fr

Study Locations

• France
  • IDF
    • Paris, IDF, France, 75006
      • Recruiting
      • Psychiatrie Adultes Et Addictologie
      • Contact: Florence THIBAUT

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

All tobacco smokers who will ask for consultation in our ward.

Description

Inclusion Criteria:

• Men and women over the age of 18
• Nicotine dependent subjects according to the Fagerström test (score ≥5)
• Subjects consuming daily tobacco.
• Subjects understanding and reading French and able to express themselves in this language.
• Signed informed consent to participate indicating that the subject has understood the purpose and the procedures required by the study and agrees to participate in the study and to comply with the requirements and limitations of this study
• Affiliation to the French social security scheme or beneficiary of such a scheme.
• No other method to decrease or stop smoking at the same time as the study.

Exclusion Criteria:

• Guardianship
• Pregnant or lactating woman
• Patient under AME
• Subject being in the exclusion period of another study or provided for by the "National Volunteer File".
• Subjects with intracranial hypertension
• Subject unlikely to cooperate with the study and / or weak cooperation anticipated by the investigator.
• Treatment with buproprion or varenicline in progress
• Episode or family history of epilepsy, convulsion.
• Disease causing damage to the brain (aneurysm, tumor, ...).
• Cochlear or ocular implant.
• Stimulator or cardiac defibrillator.
• Presence of metal in the skull (clip on aneurysm, prosthesis, ...).
• Eczema on the scalp.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Fagerström score (3 is the highest score and O the lowest one for item 1. A score of 1 or 2 means low dependence (for item 1 only as well as if you use the total score)	average difference in Fagerström score 1 scores that assess craving for tobacco between pre-treatment assessment (J0) and short-term post-treatment evaluations (J15).	15 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
tobacco consumption	Evaluation of changes in tobacco consumption and smoking craving intensity and tolerance of tDCS	15 days

Collaborators and Investigators

• Sponsor: Assistance Publique - Hôpitaux de Paris
• Collaborators: URC Necker Cochin, France

Study record dates

Study Major Dates

• Study Start (Actual): November 29, 2021
• Primary Completion (Estimated): February 28, 2028
• Study Completion (Estimated): May 29, 2028

Study Registration Dates

• First Submitted: December 20, 2019
• First Submitted That Met QC Criteria: December 20, 2019
• First Posted (Actual): December 23, 2019

Study Record Updates

• Last Update Posted (Estimated): September 12, 2025
• Last Update Submitted That Met QC Criteria: September 5, 2025
• Last Verified: September 1, 2025

More Information

Terms related to this study

• Keywords: addiction; Tobacco; adults; transcranial non invasive direct brain stimulation
• Additional Relevant MeSH Terms: Compulsive Behavior; Impulsive Behavior; Behavior; Behavior, Addictive; Therapeutics; Behavioral Disciplines and Activities; Electric Stimulation Therapy; Convulsive Therapy; Psychiatric Somatic Therapies; Electroshock; Psychological Techniques; Transcranial Direct Current Stimulation
• Other Study ID Numbers: APHP190731; 2019-A01946-51 (Other Identifier: IDRCB)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No