Smoking CessationTABACSTIM 3NCT05152810
Effectiveness of Transcranial Magnetic Stimulation (TMS) in Smoking Cessation, Combining Withdrawal Stimulation Followed by Maintenance Stimulation to Prevent Relapse
A study testing Transcranial Magnetic Stimulation sessions and Evaluations in people with Smoking Cessation, run by Centre Hospitalier Universitaire Dijon at 1 site in France.
Trial summary
Smoking cessation 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 after 12 months of smoking cessation. 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?
- Transcranial Magnetic Stimulation sessions and Evaluations
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 88 participants
- Where
- 1 siteFrance
- Study dates
- 6 Jan 2022to 20 Nov 2025
- 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 who wants to quit smoking
- Patient with a smoking disorder (DSM-5 criteria)
- Patient with at least 1 previous failed smoking cessation treatment with recommended medications (nicotine, vareniciline, or bupropion)
Who cannot join
- Patient not affiliated to the national health insurance system
- Patient subject to a measure of legal protection (curatorship, guardianship)
- Pregnant or breast-feeding woman
- Patient of childbearing age with a positive pregnancy test at inclusion
- Patients of legal age who are unable to express their consent
- Patient abstinent in the previous 3 months
Show all 15Show fewer
- Patient with a substance use disorder (DSM-5 criteria)
- Patient with a contraindication to TMS: personal history of seizure, pacemaker, neurosurgical clips, carotid or aortic clips, heart valves, hearing aids, ventricular shunt valves, sutures with wires or staples, foreign bodies in the eye, shrapnel, other prosthesis or cephalic ferromagnetic material
- Patient employed in the addictology department of the CHU of Dijon (department of the principal investigator)
- Patient with severe depression, defined by a score greater than or equal to 24 on the Hamilton Depression Rating Scale (HDRS)
- Patient having had a recent change (< 1 month) in the prescription of a psychotropic treatment
- Patients with severe and/or chronic psychiatric disorders, including schizophrenia, paranoia, and bipolar disorder types I and II
- Patients with severe heart, kidney, liver or lung failure or other conditions that could compromise the patient's participation in the study in the opinion of the physician
- Patient concurrently participating in another therapeutic trial
- Patient who has already participated in a transcranial magnetic stimulation session
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy of Transcranial Magnetic Stimulation (TMS) in Smoking Cessation, Combining Withdrawal Stimulations Followed by Maintenance Stimulations to Prevent Relapse: a Single-center, Randomized, Controlled, Blinded Pilot Study
Smoking cessation 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 after 12 months of smoking cessation. The use of nicotine replacement therapy only increases the chances of successful smoking cessation by 2-3%.
Brain imaging research shows that the dorsolateral prefrontal cortex (DLPC) is involved in tobacco addiction. Disorders induced in the DLPC cause an irrepressible urge to smoke (craving) and largely explain relapse during smoking cessation.
Read more
Transcranial Magnetic Stimulation (TMS) could be a promising tool in the quest for an effective approach to smoking cessation. This technique is used for direct stimulation of the DLPC via a magnetic coil in order to reduce the cortical activity of the DLPC and thus to reduce cravings.
A first randomized controlled study using TMS was conducted at the University Hospital of Dijon in highly addicted smokers who had failed to quit with the usual withdrawal strategies. In this study, entitled Tabacstim 1, we found that the combination of nicotine substitutes (to reduce physical withdrawal symptoms) with 10 "attack" sessions of TMS (to reduce cravings) increased the rate of abstinence during the first 2 weeks of withdrawal (% abstinence = 88. However, in this study, the therapeutic effect of the nicotine-SMT combination was not prolonged once the stimuli were 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.
We therefore initiated a new study, entitled Tabacstim 2, to add maintenance brain stimulation to the Tabacstim 1 protocol after the "attack" sessions (this therapeutic scheme is classically used in the treatment of depression with TMS). This study started in July 2020 and will end very soon (71 inclusions completed out of the 78 expected).
In both Tabacstim 1 and Tabacstim 2, the stimulations are delivered at low frequency (1 Hz) on the right DLPC. However, a recently published meta-analysis shows that, in addictions, stimulations delivered at a high frequency (10 Hz) on the left DLPC appear to be more effective in reducing craving. But above all, another meta-analysis carried out by our team (in progress of publication), finds that excitatory stimulations (such as 10 Hz rTMS) on the left DLPC are very effective in maintaining smoking abstinence in the medium term (3 and 6 months), which does not seem to be the case for inhibitory stimulations (such as 1 Hz rTMS).
We therefore wish to carry out the Tabacstim 3 study, which only differs from Tabacstim 2 in two stimulation parameters: 10 Hz stimulations on the left DLPC instead of 1 Hz stimulations on the right DLPC. We therefore propose in Tabacstim 3 to use excitatory stimulations on the left instead of inhibitory stimulations on the right.
Tabacstim 3 could be more effective for prolonged smoking cessation than the 2 previous protocols.
- Conditions
- Smoking Cessation
- Being tested
- Transcranial Magnetic Stimulation sessions, Evaluations
- Medical subject headings
- Smoking Cessation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transcranial Magnetic Stimulation sessionsOther
- 10 sessions daily from Monday to Friday (2 sessions/day, 15 minutes apart) during the 1st week = attack phase
- 2 weekly maintenance sessions the following week (S2), then 1 weekly maintenance session the following 4 weeks (S3, S4, S5 and S6) = maintenance phase
EvaluationsOther
Before the first stimulation session, just after the 10th session, at 6 weeks, at 12 weeks and at 24 weeks.
The assessment included the collection of AEs/EIGs, the TAC, the VAS on "desire to smoke", the TCQ, the QSU, BDI-II (except at S1), the CO tester, GoNoGo, the PQI and the ISI.
| Study group | Role | What they receive |
|---|---|---|
| Active Transcranial Magnetic Stimulation | Experimental | Not described Receives: Other: Transcranial Magnetic Stimulation sessions; Other: Evaluations |
| Transcranial magnetic resonance imaging placebo | Placebo comparator | Not described Receives: Other: Transcranial Magnetic Stimulation sessions; Other: Evaluations |
What is being measured
The primary outcome is the main question the study is designed to answer.
Continuous Abstinence Rate
Continuous Abstinence Rate is defined according to Russell criteria as the proportion of patients reporting <5 cigarettes smoked since the 2nd week after the date of randomization (1 TMS session) AND biochemically validated by an expired carbon monoxide level of less than 10 ppm at follow-up and not contradicted by a previous self-report or validation result.
Measured: within 6 weeks of starting to quit smoking
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Dec 2021
- Study start6 Jan 2022
- Primary completion20 Nov 2025
- Study completion20 Nov 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- None (open label)
- Enrolment
- 88 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
- NCT05152810
- Sponsor's protocol ID
- TROJAK 2021
- Acronym
- TABACSTIM 3
- Status last verified
- Feb 2026
- First submitted
- 24 Nov 2021
- Last updated
- 25 Feb 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Transcranial Magnetic Stimulation (TMS) in Smoking Cessation, Combining Withdrawal Stimulations Followed by Maintenance Stimulations to Prevent Relapse: a Single-center, Randomized, Controlled, Blinded Pilot Study
- ClinicalTrials.gov ID
- NCT05152810
- Acronym / sponsor ID
- TABACSTIM 3 / TROJAK 2021
- Conditions
- Smoking Cessation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 88 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire DijonUniversity, hospital or other
- Study start
- 6 Jan 2022 (actual)
- Primary completion
- 20 Nov 2025 (actual)
- Study completion
- 20 Nov 2025 (actual)
- First posted
- 10 Dec 2021 (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.
Smoking cessation 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 after 12 months of smoking cessation. The use of nicotine replacement therapy only increases the chances of successful smoking cessation by 2-3%.
Brain imaging research shows that the dorsolateral prefrontal cortex (DLPC) is involved in tobacco addiction. Disorders induced in the DLPC cause an irrepressible urge to smoke (craving) and largely explain relapse during smoking cessation.
Transcranial Magnetic Stimulation (TMS) could be a promising tool in the quest for an effective approach to smoking cessation. This technique is used for direct stimulation of the DLPC via a magnetic coil in order to reduce the cortical activity of the DLPC and thus to reduce cravings.
A first randomized controlled study using TMS was conducted at the University Hospital of Dijon in highly addicted smokers who had failed to quit with the usual withdrawal strategies. In this study, entitled Tabacstim 1, we found that the combination of nicotine substitutes (to reduce physical withdrawal symptoms) with 10 "attack" sessions of TMS (to reduce cravings) increased the rate of abstinence during the first 2 weeks of withdrawal (% abstinence = 88. However, in this study, the therapeutic effect of the nicotine-SMT combination was not prolonged once the stimuli were 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.
We therefore initiated a new study, entitled Tabacstim 2, to add maintenance brain stimulation to the Tabacstim 1 protocol after the "attack" sessions (this therapeutic scheme is classically used in the treatment of depression with TMS). This study started in July 2020 and will end very soon (71 inclusions completed out of the 78 expected).
In both Tabacstim 1 and Tabacstim 2, the stimulations are delivered at low frequency (1 Hz) on the right DLPC. However, a recently published meta-analysis shows that, in addictions, stimulations delivered at a high frequency (10 Hz) on the left DLPC appear to be more effective in reducing craving. But above all, another meta-analysis carried out by our team (in progress of publication), finds that excitatory stimulations (such as 10 Hz rTMS) on the left DLPC are very effective in maintaining smoking abstinence in the medium term (3 and 6 months), which does not seem to be the case for inhibitory stimulations (such as 1 Hz rTMS).
We therefore wish to carry out the Tabacstim 3 study, which only differs from Tabacstim 2 in two stimulation parameters: 10 Hz stimulations on the left DLPC instead of 1 Hz stimulations on the right DLPC. We therefore propose in Tabacstim 3 to use excitatory stimulations on the left instead of inhibitory stimulations on the right.
Tabacstim 3 could be more effective for prolonged smoking cessation than the 2 previous protocols.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active Transcranial Magnetic Stimulation | Experimental | Other: Transcranial Magnetic Stimulation sessions, Other: Evaluations |
| Transcranial magnetic resonance imaging placebo | Placebo comparator | Other: Transcranial Magnetic Stimulation sessions, Other: Evaluations |
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 who wants to quit smoking
- Patient with a smoking disorder (DSM-5 criteria)
- Patient with at least 1 previous failed smoking cessation treatment with recommended medications (nicotine, vareniciline, or bupropion)
Key exclusion criteria (15 listed)
- Patient not affiliated to the national health insurance system
- Patient subject to a measure of legal protection (curatorship, guardianship)
- Pregnant or breast-feeding woman
- Patient of childbearing age with a positive pregnancy test at inclusion
- Patients of legal age who are unable to express their consent
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 Magnetic Stimulation sessions* 10 sessions daily from Monday to Friday (2 sessions/day, 15 minutes apart) during the 1st week = attack phase * 2 weekly maintenance sessions the following week (S2), then 1 weekly maintenance session the following 4 weeks (S3, S4, S5 and S6) = maintenance phase | Other | Active Transcranial Magnetic Stimulation, Transcranial magnetic resonance imaging placebo |
| EvaluationsBefore the first stimulation session, just after the 10th session, at 6 weeks, at 12 weeks and at 24 weeks. The assessment included the collection of AEs/EIGs, the TAC, the VAS on "desire to smoke", the TCQ, the QSU, BDI-II (except at S1), the CO tester, GoNoGo, the PQI and the ISI. | Other | Active Transcranial Magnetic Stimulation, Transcranial magnetic resonance imaging placebo |
Primary outcome
Continuous Abstinence Rate
Time frame: within 6 weeks of starting to quit smoking
Continuous Abstinence Rate is defined according to Russell criteria as the proportion of patients reporting <5 cigarettes smoked since the 2nd week after the date of randomization (1 TMS session) AND biochemically validated by an expired carbon monoxide level of less than 10 ppm at follow-up and not contradicted by a previous self-report or validation result.
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 25 Feb 2026.
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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 Transcranial Magnetic Stimulation sessions and Evaluations 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 25 Feb 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: within 6 weeks of starting to quit smoking). 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 25 Feb 2026.