Direct Transcranial Electrical Stimulation in Tobacco Addiction (tDCS)

NCT ID: NCT04209153

Last Updated: 2025-09-12

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 100 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2021-11-29
• Study Completion Date: 2028-05-29

Brief Summary

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.

Conditions

Adults (Male and Female Subjects) With Tobacco Dependence

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Interventions

Transcranial Direct Current Stimulation

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

Intervention Type: OTHER

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

URC-CIC Paris Descartes Necker Cochin

OTHER

Sponsor Role: collaborator

Assistance Publique - Hôpitaux de Paris

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Psychiatrie Adultes Et Addictologie

Paris, IDF, France

Site Status: RECRUITING

Countries

France

Central Contacts

Florence THIBAUT, PHD

Role: CONTACT

florence.thibaut@aphp.fr

(33) 1 58 41 16 79

Marie BENHAMMANI-GODARD

Role: CONTACT

marie.godard@aphp.fr

(33) 1 58 41 11 90

Facility Contacts

Florence THIBAUT

Role: primary

Other Identifiers

2019-A01946-51

Identifier Type: OTHER

Identifier Source: secondary_id

APHP190731

Identifier Type: -

Identifier Source: org_study_id