An interventional study of Active TCS and Placebo TCS in Smoking Cessation, sponsored by Centre Hospitalier Universitaire Dijon. Completed at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-02-22.
Sponsored by Centre Hospitalier Universitaire Dijon · Not applicable, Interventional, and Treatment
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.
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This study's enrollment of 79 is above the median of 50 across 3,374 interventional studies indexed under Recurrence.
Browse Recurrence studies →Centre Hospitalier Universitaire Dijon is the lead sponsor of 495 studies on the registry; 105 are open to participants now.
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Exclusion Criteria:
Device: Active TCS · Drug: nicotine treatment · Other: Questionnaires
Device: Placebo TCS · Drug: nicotine treatment · Other: Questionnaires
TCS active at 1 Hz on the right DLPFC for 6 weeks
Inactive TCS (placebo coil) at 1 Hz on right DLPFC for 6 weeks
at least 21/14/7 mg/d + oral nicotine cp from 2 to 30 mg/d)
EVA on "craving", TCQ, QSU, BDI-II, CO tester, IGT, BART
Continuous Abstinence Rate
Continuous Abstinence Rate within 6 weeks of starting to quit smoking
Time frame: Through study completion, an average of 12 months
This study is completed, as verified in Feb 2024. You cannot join it, but the record below documents what was studied.
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Centre Hospitalier Universitaire Dijon