Chu Dijon Bourgogne
Dijon, 21000, France
NCT Number: NCT04591743
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.
Looking for future studies?
Notify Me18 year and older
All sexes
Interventional
Not applicable
Dijon, 21000, France
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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
Time frame: Through study completion, an average of 12 months
Continuous Abstinence Rate within 6 weeks of starting to quit smoking
Centre Hospitalier Universitaire Dijon
Other
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
Acronym: TabacStim2
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT05130788
Behavior, Health Behavior
New York, United States
View Trial DetailsNCT06663020
Behavior, Bronchial Neoplasms
Samsun, Turkey (Türkiye)
View Trial DetailsNCT04881630
Behavior, Health Behavior
Oklahoma City, Oklahoma, United States
View Trial DetailsNCT04620915
Behavior, Cancer
Eugene, Oregon, United States
View Trial Details