Clinical trial NCT04209153: Direct Transcranial Electrical Stimulation in Tobacco Addiction (tDCS)
Official title: Evaluation of the Effect of Transcranial Direct Current Stimulation (tDCS) in Nicotine-Dependent Tobacco Users
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Adults (male and Female Subjects) with Tobacco Dependence
Keywords: Tobacco
addiction
transcranial non invasive direct brain stimulation
adults
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
First posted: 2019-12-23
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All tobacco smokers who will ask for consultation in our ward.

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.


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.

Primary outcomes:
measure: 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)
timeFrame: 15 days
Secondary outcomes:
measure: tobacco consumption
timeFrame: 15 days
Other outcomes:
Locations:
city: Paris
country: France
facility: Psychiatrie Adultes Et Addictologie
state: IDF
Study officials:
References: