Adults (Male and Female Subjects) With Tobacco DependencetDCSNCT04209153
Direct Transcranial Electrical Stimulation in Tobacco Addiction (tDCS)
An observational study of Adults (Male and Female Subjects) With Tobacco Dependence, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Adults (Male and Female Subjects) With Tobacco Dependence
- What is being tested?
- Transcranial Direct Current Stimulation
- How many people
- 100 participants
- Where
- 1 siteFrance
- Study dates
- 29 Nov 2021to 29 May 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
Study population: All tobacco smokers who will ask for consultation in our ward.
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Psychiatrie Adultes Et Addictologie
Paris, IDF, 75006
Florence THIBAUT
About this study
Official title: Evaluation of the Effect of Transcranial Direct Current Stimulation (tDCS) in Nicotine-Dependent Tobacco Users
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.
- Being tested
- Transcranial Direct Current Stimulation
- Keywords
- Tobacco, addiction, transcranial non invasive direct brain stimulation, adults
- Medical subject headings
- Behavior, Addictive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transcranial Direct Current StimulationOther
tDCS sessions (with Direct Transcranial Electrical Stimulation (tDCS) device - Neuroelectrics
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
average difference in Fagerström score 1 scores that assess craving for tobacco between pre-treatment assessment (J0) and short-term post-treatment evaluations (J15).
Measured: 15 days
Secondary outcomes (1)
tobacco consumption
Evaluation of changes in tobacco consumption and smoking craving intensity and tolerance of tDCS
Measured: 15 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Dec 2019
- Study start29 Nov 2021
- Primary completion28 Feb 2028 (estimated)
- Study completion29 May 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Adults (Male and Female Subjects) With Tobacco DependenceStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Collaborators
- URC-CIC Paris Descartes Necker Cochin
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04209153
- Sponsor's protocol ID
- APHP190731
- Other IDs
- 2019-A01946-51
- Acronym
- tDCS
- Status last verified
- Sep 2025
- First submitted
- 20 Dec 2019
- Last updated
- 12 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Effect of Transcranial Direct Current Stimulation (tDCS) in Nicotine-Dependent Tobacco Users
- ClinicalTrials.gov ID
- NCT04209153
- Acronym / sponsor ID
- tDCS / APHP190731
- Keywords
- Tobacco, addiction, transcranial non invasive direct brain stimulation, adults
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Collaborators
- URC-CIC Paris Descartes Necker Cochin
- Study start
- 29 Nov 2021 (actual)
- Primary completion
- 28 Feb 2028 (estimated)
- Study completion
- 29 May 2028 (estimated)
- First posted
- 23 Dec 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- All tobacco smokers who will ask for consultation in our ward.
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (13 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Transcranial Direct Current StimulationtDCS sessions (with Direct Transcranial Electrical Stimulation (tDCS) device - Neuroelectrics | Other | – |
Primary outcome
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).
1 secondary outcome
tobacco consumption
Time frame: 15 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Sep 2025.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Adults (Male and Female Subjects) With Tobacco Dependence, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 12 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Florence THIBAUT, PHD ((33) 1 58 41 16 79, florence.thibaut@aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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) (time frame: 15 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Sep 2025.