NCT04209153 Direct Transcranial Electrical Stimulation in Tobacco Addiction (tDCS)
| NCT ID | NCT04209153 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Assistance Publique - Hôpitaux de Paris |
| Condition | Adults (Male and Female Subjects) With Tobacco Dependence |
| Study Type | OBSERVATIONAL |
| Enrollment | 100 participants |
| Start Date | 2021-11-29 |
| Primary Completion | 2028-02-28 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 100 participants in total. It began in 2021-11-29 with a primary completion date of 2028-02-28.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT04209153 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Adults (Male and Female Subjects) With Tobacco Dependence. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT04209153 currently recruiting?
Yes, NCT04209153 is actively recruiting participants. Contact the research team at florence.thibaut@aphp.fr for enrollment information.
Where is the NCT04209153 trial being conducted?
This trial is being conducted at Paris, France.
Who is sponsoring the NCT04209153 clinical trial?
NCT04209153 is sponsored by Assistance Publique - Hôpitaux de Paris. The trial plans to enroll 100 participants.