Smoking CessationTabacStim2NCT04591743
Effectiveness of Transcranial Magnetic Stimulation (TMS) in Smoking Cessation, Combining Withdrawal Stimulation Followed by Maintenance Stimulation to Prevent Relapse.
A study testing Active TCS, nicotine treatment and Questionnaires in people with Smoking Cessation, run by Centre Hospitalier Universitaire Dijon at 1 site in France.
Trial summary
Tobacco control is a Public Health priority. Tobacco is directly responsible for 75,000 deaths per year in France. Without help, less than 5% of smokers are still abstinent within 12 months of quitting. The use of nicotine substitutes only increases the chances of success in smoking cessation by 2 to 3%. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Smoking Cessation
- What is being tested?
- Active TCS, nicotine treatment and Questionnaires
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 79 participants
- Where
- 1 siteFrance
- Study dates
- 29 Jun 2020to 7 Oct 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient who has given oral consent
- Adult patient
- Patient wishing to stop smoking
- Patient highly addicted to nicotine (≥ score 7 on Fagerström's self-questionnaire*)
- Patient with at least 1 previous smoking cessation failure using recommended drug therapies (nicotine, vareniciline, bupropion)
Who cannot join
- Patient not affiliated or not benefiting from national health insurance
- Person deprived of their liberty by judicial or administrative decision
- Protected adults (curatorship, guardianship)
- Pregnant, parturient or breastfeeding woman
- Patient of childbearing age with a positive pregnancy test at inclusion
- Major patient incapable or unable to express consent
Show all 15Show fewer
- Patient abstinent in the previous 3 months
- Patient with a substance use disorder (DSM-5 criteria) with other psychoactive substances other than tobacco
- Patient with a contraindication to the practice of TCS; personal history of seizure, pacemaker, neurosurgical clips, carotid or aortic clips, heart valves, hearing aid, ventricular bypass valve, sutures with wires or staples, foreign bodies in the eye, shrapnel, other prosthesis or cephalic ferromagnetic material.
- Patient employed by the investigator or trial site
- Patient with severe depression, defined by a score greater than or equal to 24 on the Hamilton Depression Rating Scale
- Patient who has had a recent change (< 1 month) in the prescription of psychotropic treatment
- Patient with severe and/or chronic psychiatric disorders, including schizophrenia, paranoia, and bipolar disorders type I and II.
- Patient with severe heart, kidney, liver or lung failure or other condition that the physician believes may compromise the patient's participation in the study.
- Patient simultaneously participating in another therapeutic trial
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effectiveness of Transcranial Magnetic Stimulation (TMS) in Smoking Cessation, Combining Withdrawal Stimulation Followed by Maintenance Stimulation to Prevent Relapse: Single-center, Randomized, Controlled, Blinded Pilot Study
Tobacco control is a Public Health priority. Tobacco is directly responsible for 75,000 deaths per year in France. Without help, less than 5% of smokers are still abstinent within 12 months of quitting. The use of nicotine substitutes only increases the chances of success in smoking cessation by 2 to 3%.
Brain imaging research shows that the dorsolateral prefrontal cortex (DLPFC) is involved in tobacco addiction. Disorders induced in the CPFDL cause an irrepressible desire to smoke (craving) and explain a large part of the relapse at the time of smoking cessation.
Read more
Transcranial magnetic stimulation (TMS) could be promising in smoking cessation. This technique allows direct stimulation of the DLPFC via a magnetic coil, so as to reduce the cortical activity of the DLPFC, and thus reduce tobacco craving.
A first randomized controlled study was conducted at the Dijon University Hospital in Dijon in smokers who were heavily addicted and who had failed with the usual withdrawal strategies. In this study, it was found that the combination of nicotine substitutes (to reduce the physical symptoms of withdrawal) with 10 sessions of TCS (to reduce craving) made it possible to maintain abstinence from tobacco during the first 2 weeks of withdrawal (% abstinence = 88.8% active TCS group vs. 50% placebo TCS group; p=0.027).
However, in this study, the therapeutic effect of the nicotine-TCS combination was not prolonged once the stimuli stopped. At 6 and 12 weeks from the start of withdrawal, abstinence rates in the active SMT and placebo SMT groups were no longer significantly different.
It is therefore proposed to renew the protocol by adding maintenance brain stimulation to the initial protocol. Used in the treatment of depression, the maintenance brain stimuli could increase the chances of smoking cessation.
- Conditions
- Smoking Cessation
- Being tested
- Active TCS, Placebo TCS, nicotine treatment, Questionnaires
- Medical subject headings
- Smoking Cessation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Active TCSDevice
TCS active at 1 Hz on the right DLPFC for 6 weeks
Placebo TCSDevice
Inactive TCS (placebo coil) at 1 Hz on right DLPFC for 6 weeks
nicotine treatmentDrug
at least 21/14/7 mg/d + oral nicotine cp from 2 to 30 mg/d)
QuestionnairesOther
EVA on "craving", TCQ, QSU, BDI-II, CO tester, IGT, BART
| Study group | Role | What they receive |
|---|---|---|
| Experimental group | Experimental | Not described Receives: Device: Active TCS; Drug: nicotine treatment; Other: Questionnaires |
| Placebo group | Placebo comparator | Not described Receives: Device: Placebo TCS; Drug: nicotine treatment; Other: Questionnaires |
What is being measured
The primary outcome is the main question the study is designed to answer.
Continuous Abstinence Rate
Continuous Abstinence Rate within 6 weeks of starting to quit smoking
Measured: Through study completion, an average of 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2020
- Study start29 Jun 2020
- Primary completion7 Oct 2022
- Study completion7 Oct 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Smoking CessationStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire DijonThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 79 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire Dijon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04591743
- Sponsor's protocol ID
- TROJAK CRBFC-E 2019
- Acronym
- TabacStim2
- Status last verified
- Feb 2024
- First submitted
- 12 Oct 2020
- Last updated
- 8 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Demina A, Petit B, Soudry-Faure A, Goueslard K, Trojak B. Low-frequency rTMS in combination with nicotine replacement therapy for smoking cessation: a phase II non-comparative Fleming-type randomized, double-blind, sham-controlled trial. Nicotine Tob Res. 2026 May 7:ntag097. doi: 10.1093/ntr/ntag097. Online ahead of print.
PubMed 42096636
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Transcranial Magnetic Stimulation (TMS) in Smoking Cessation, Combining Withdrawal Stimulation Followed by Maintenance Stimulation to Prevent Relapse: Single-center, Randomized, Controlled, Blinded Pilot Study
- ClinicalTrials.gov ID
- NCT04591743
- Acronym / sponsor ID
- TabacStim2 / TROJAK CRBFC-E 2019
- Conditions
- Smoking Cessation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 79 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire DijonUniversity, hospital or other
- Study start
- 29 Jun 2020 (actual)
- Primary completion
- 7 Oct 2022 (actual)
- Study completion
- 7 Oct 2022 (actual)
- First posted
- 19 Oct 2020 (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.
Tobacco control is a Public Health priority. Tobacco is directly responsible for 75,000 deaths per year in France. Without help, less than 5% of smokers are still abstinent within 12 months of quitting. The use of nicotine substitutes only increases the chances of success in smoking cessation by 2 to 3%.
Brain imaging research shows that the dorsolateral prefrontal cortex (DLPFC) is involved in tobacco addiction. Disorders induced in the CPFDL cause an irrepressible desire to smoke (craving) and explain a large part of the relapse at the time of smoking cessation.
Transcranial magnetic stimulation (TMS) could be promising in smoking cessation. This technique allows direct stimulation of the DLPFC via a magnetic coil, so as to reduce the cortical activity of the DLPFC, and thus reduce tobacco craving.
A first randomized controlled study was conducted at the Dijon University Hospital in Dijon in smokers who were heavily addicted and who had failed with the usual withdrawal strategies. In this study, it was found that the combination of nicotine substitutes (to reduce the physical symptoms of withdrawal) with 10 sessions of TCS (to reduce craving) made it possible to maintain abstinence from tobacco during the first 2 weeks of withdrawal (% abstinence = 88.8% active TCS group vs. 50% placebo TCS group; p=0.027).
However, in this study, the therapeutic effect of the nicotine-TCS combination was not prolonged once the stimuli stopped. At 6 and 12 weeks from the start of withdrawal, abstinence rates in the active SMT and placebo SMT groups were no longer significantly different.
It is therefore proposed to renew the protocol by adding maintenance brain stimulation to the initial protocol. Used in the treatment of depression, the maintenance brain stimuli could increase the chances of smoking cessation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental group | Experimental | Device: Active TCS, Drug: nicotine treatment, Other: Questionnaires |
| Placebo group | Placebo comparator | Device: Placebo TCS, Drug: nicotine treatment, Other: Questionnaires |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patient who has given oral consent
- Adult patient
- Patient wishing to stop smoking
- Patient highly addicted to nicotine (≥ score 7 on Fagerström's self-questionnaire*)
- Patient with at least 1 previous smoking cessation failure using recommended drug therapies (nicotine, vareniciline, bupropion)
Key exclusion criteria (15 listed)
- Patient not affiliated or not benefiting from national health insurance
- Person deprived of their liberty by judicial or administrative decision
- Protected adults (curatorship, guardianship)
- Pregnant, parturient or breastfeeding woman
- Patient of childbearing age with a positive pregnancy test at inclusion
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 |
|---|---|---|
| Active TCSTCS active at 1 Hz on the right DLPFC for 6 weeks | Device | Experimental group |
| Placebo TCSInactive TCS (placebo coil) at 1 Hz on right DLPFC for 6 weeks | Device | Placebo group |
| nicotine treatmentat least 21/14/7 mg/d + oral nicotine cp from 2 to 30 mg/d) | Drug | Experimental group, Placebo group |
| QuestionnairesEVA on "craving", TCQ, QSU, BDI-II, CO tester, IGT, BART | Other | Experimental group, Placebo group |
Primary outcome
Continuous Abstinence Rate
Time frame: Through study completion, an average of 12 months
Continuous Abstinence Rate within 6 weeks of starting to quit smoking
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2026.
- Results publication: PubMed 42096636Demina A, Petit B, Soudry-Faure A, Goueslard K, Trojak B. Low-frequency rTMS in combination with nicotine replacement therapy for smoking cessation: a phase II non-comparative Fleming-type randomized, double-blind, sham-controlled trial. Nicotine Tob Res. 2026 May 7:ntag097. doi: 10.1093/ntr/ntag097. Online ahead of print.
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Active TCS, nicotine treatment and Questionnaires in people with Smoking Cessation, run by Centre Hospitalier Universitaire Dijon 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 5 inclusion and 15 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: finished, as of the sponsor's last update on 8 Oct 2026. 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. Some participants in this study may receive a placebo. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Continuous Abstinence Rate (time frame: Through study completion, an average of 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04591743, which also lists 1 linked publication.
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 8 Oct 2026.