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NCT Number: NCT04209153

Direct Transcranial Electrical Stimulation in Tobacco Addiction (tDCS)

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Psychiatrie Adultes Et Addictologie

Paris, IDF, 75006, France

Location status: Recruiting

Location contact

Florence THIBAUT

CONTACT

Who can participate

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

transcranial direct current stimulation

Other

tDCS sessions (with Direct Transcranial Electrical Stimulation (tDCS) device - Neuroelectrics

Primary outcomes

  1. 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)

    Time frame: 15 days

    average difference in Fagerström score 1 scores that assess craving for tobacco between pre-treatment assessment (J0) and short-term post-treatment evaluations (J15).

Secondary outcomes

  1. tobacco consumption

    Time frame: 15 days

    Evaluation of changes in tobacco consumption and smoking craving intensity and tolerance of tDCS

Study contacts

Contact information is provided by the study sponsor or research team.

Florence THIBAUT, PHD

CONTACT

[email protected]

(33) 1 58 41 16 79

Marie BENHAMMANI-GODARD

CONTACT

[email protected]

(33) 1 58 41 11 90

Sponsors and collaborators

Lead sponsor

Assistance Publique - Hôpitaux de Paris

Other

Collaborators

  • URC-CIC Paris Descartes Necker Cochin

Registry information

Official study title

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

Acronym: tDCS

Important dates

Study start
2021
Primary completion
2028
Study completion
2028
First posted
Dec 23, 2019
Registry last updated
Sep 12, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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