Smoking CessationrTMS TABACNCT02812810
Evaluation of the Efficacy of Repetitive Transcranial Magnetic Stimulation (rTMS) Low-frequency on Craving in Smoking Dependence
A study testing active rTMS in people with Smoking Cessation and Addiction, run by Centre Hospitalier Universitaire Dijon at 1 site in France.
Trial summary
The fight against smoking is a public health priority. Without help, fewer than 5% of des smokers are abstinent at 12 months after smoking cessation. Despite well-managed attempts at smoking cessation with nicotine substitutes, the rate of success at 12 months in patients dependent on nicotine is only 18%. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Smoking Cessation, Addiction
- What is being tested?
- active rTMS
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 39 participants
- Where
- 1 siteFrance
- Study dates
- Sep 2011to Feb 2015
- 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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult 18-65 years old
- Wishing to stop smoking
- Highly dependent on nicotine (score ≥ 7 on the Fagerström self-questionnaire)
- History of at least 2 failed attempts to stop smoking despite recommended treatments (nicotine, vareniciline, bupropion)
Who cannot join
- Abstinence in the 3 previous months
- Absence of effective contraception for women
- Progressive chronic disease
- Ongoing psychiatric disorders
- Current addiction to other substances or cessation of less than one year
- Current treatment with psychotropic agents
Show all 9Show fewer
- Epilepsy and other contra-indications for rTMS (pacemaker, metallic clips or other electronic implants, head trauma, intracranial hypertension).
- Contra-indications for transdermal nicotine substitutes (recent myocardial infarction, unstable or worsening angina, Prinzmetal angina, severe heart rhythm disorders, recent stroke, skin disorders that could interfere with the use of transdermal treatments, hypersensitivity to one of the constituents).
- Personnel working in the psychiatric and addictology unit of the CHU (conflict of interest)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of the Efficacy of Low-frequency rTMS on Craving in Smoking Dependence: Single-centre Randomized, Controlled Blinded Pilot Study
The fight against smoking is a public health priority. Without help, fewer than 5% of des smokers are abstinent at 12 months after smoking cessation.
Despite well-managed attempts at smoking cessation with nicotine substitutes, the rate of success at 12 months in patients dependent on nicotine is only 18%. Moreover, other therapeutic strategies (acupuncture, hypnosis…) have not proved to be effective.
The investigators propose a new therapeutic strategy for smoking cessation, which is based on associating nicotine substitutes (to reduce physical symptoms of weaning from nicotine) with rTMS at 1 Hz to the right DorsoLateral PreFrontal Cortex (DLPFC) for 2 weeks (to diminish craving for tobacco). The principal objective is to improve the success rate for smoking cessation attempts in patients who are highly dependent on nicotine, and who have failed using usual smoking cessation strategies.
- Conditions
- Smoking Cessation, Addiction
- Being tested
- active rTMS, sham rTMS
- Medical subject headings
- Smoking Cessation, Behavior, Addictive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
active rTMSDevice
sham rTMSDevice
| Study group | Role | What they receive |
|---|---|---|
| active rTMS | Experimental | Not described Receives: Device: active rTMS |
| placebo rTMS | Placebo comparator | Not described Receives: Device: sham rTMS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline score of Tabacco Craving Questionnaire (TCQ)
Measured: at Week 0, Week 1, Week 2, Week 6 and Week 12 after stimulation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2016 (estimated)
- Study startSep 2011
- Primary completionFeb 2015
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
- 39 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
- NCT02812810
- Sponsor's protocol ID
- TROJAK DRCI 2010
- Acronym
- rTMS TABAC
- Status last verified
- Feb 2026
- First submitted
- 20 Jun 2016
- Last updated
- 6 Feb 2026
- Results posted
- No
Publications
Trojak B, Meille V, Achab S, Lalanne L, Poquet H, Ponavoy E, Blaise E, Bonin B, Chauvet-Gelinier JC. Transcranial Magnetic Stimulation Combined With Nicotine Replacement Therapy for Smoking Cessation: A Randomized Controlled Trial. Brain Stimul. 2015 Nov-Dec;8(6):1168-74. doi: 10.1016/j.brs.2015.06.004. Epub 2015 Jun 16.
PubMed 26590478
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Efficacy of Low-frequency rTMS on Craving in Smoking Dependence: Single-centre Randomized, Controlled Blinded Pilot Study
- ClinicalTrials.gov ID
- NCT02812810
- Acronym / sponsor ID
- rTMS TABAC / TROJAK DRCI 2010
- Conditions
- Smoking Cessation, Addiction
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 39 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire DijonUniversity, hospital or other
- Study start
- Sep 2011
- Primary completion
- Feb 2015 (actual)
- First posted
- 24 Jun 2016 (estimated)
- 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.
The fight against smoking is a public health priority. Without help, fewer than 5% of des smokers are abstinent at 12 months after smoking cessation.
Despite well-managed attempts at smoking cessation with nicotine substitutes, the rate of success at 12 months in patients dependent on nicotine is only 18%. Moreover, other therapeutic strategies (acupuncture, hypnosis…) have not proved to be effective.
The investigators propose a new therapeutic strategy for smoking cessation, which is based on associating nicotine substitutes (to reduce physical symptoms of weaning from nicotine) with rTMS at 1 Hz to the right DorsoLateral PreFrontal Cortex (DLPFC) for 2 weeks (to diminish craving for tobacco). The principal objective is to improve the success rate for smoking cessation attempts in patients who are highly dependent on nicotine, and who have failed using usual smoking cessation strategies.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| active rTMS | Experimental | Device: active rTMS |
| placebo rTMS | Placebo comparator | Device: sham rTMS |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Adult 18-65 years old
- Wishing to stop smoking
- Highly dependent on nicotine (score ≥ 7 on the Fagerström self-questionnaire)
- History of at least 2 failed attempts to stop smoking despite recommended treatments (nicotine, vareniciline, bupropion)
Key exclusion criteria (9 listed)
- Abstinence in the 3 previous months
- Absence of effective contraception for women
- Progressive chronic disease
- Ongoing psychiatric disorders
- Current addiction to other substances or cessation of less than one year
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 rTMS | Device | active rTMS |
| sham rTMS | Device | placebo rTMS |
Primary outcome
Change from Baseline score of Tabacco Craving Questionnaire (TCQ)
Time frame: at Week 0, Week 1, Week 2, Week 6 and Week 12 after stimulation
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 6 Feb 2026.
- Results publication: PubMed 26590478Trojak B, Meille V, Achab S, Lalanne L, Poquet H, Ponavoy E, Blaise E, Bonin B, Chauvet-Gelinier JC. Transcranial Magnetic Stimulation Combined With Nicotine Replacement Therapy for Smoking Cessation: A Randomized Controlled Trial. Brain Stimul. 2015 Nov-Dec;8(6):1168-74. doi: 10.1016/j.brs.2015.06.004. Epub 2015 Jun 16.
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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 rTMS in people with Smoking Cessation and Addiction, 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 4 inclusion and 9 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 6 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?
Change from Baseline score of Tabacco Craving Questionnaire (TCQ) (time frame: at Week 0, Week 1, Week 2, Week 6 and Week 12 after stimulation). 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 NCT02812810, 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 6 Feb 2026.