Using brain stimulation to help people quit smoking
Evaluation of the Effect of Transcranial Direct Current Stimulation (tDCS) in Nicotine-Dependent Tobacco Users
Assistance Publique - Hôpitaux de Paris · NCT04209153
This study is testing whether a type of brain stimulation can help daily smokers manage their cravings and quit smoking while they also receive therapy.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 100 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Assistance Publique - Hôpitaux de Paris (other) |
| Locations | 1 site (Paris, IDF) |
| Trial ID | NCT04209153 on ClinicalTrials.gov |
What this trial studies
This observational study explores the use of transcranial direct current stimulation (tDCS) as a non-invasive method to help adults with tobacco dependence manage cravings. The approach aims to provide an alternative to traditional pharmacological treatments, which often come with side effects. Participants will receive targeted brain stimulation while also engaging in psychotherapy, with the goal of reducing their tobacco use. The study focuses on individuals who are nicotine dependent and consume tobacco daily.
Who should consider this trial
Good fit: Ideal candidates are adults over 18 years old who are nicotine dependent and consume tobacco daily.
Not a fit: Patients who are pregnant, lactating, or have conditions like intracranial hypertension may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could offer a new, effective method for reducing cravings and aiding in smoking cessation without the side effects of medication.
How similar studies have performed: While the use of tDCS for addiction treatment is still emerging, preliminary studies suggest potential benefits, indicating that this approach is novel but not entirely untested.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Paris, IDF
- Psychiatrie Adultes Et Addictologie — Paris, IDF, France (RECRUITING)
Study contacts
- Study coordinator: Florence THIBAUT, PHD
- Email: florence.thibaut@aphp.fr
- Phone: (33) 1 58 41 16 79
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Adults With Tobacco Dependence, Tobacco, addiction, transcranial non invasive direct brain stimulation, adults