NCT04591743

Effectiveness of Transcranial Magnetic Stimulation (TMS) in Smoking Cessation, Combining Withdrawal Stimulation Followed by Maintenance Stimulation to Prevent Relapse.

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 79 (actual)
• Sponsor: Centre Hospitalier Universitaire Dijon · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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%. 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.

Conditions

• Smoking Cessation

Interventions

Type	Name	Description
DEVICE	Active TCS	TCS active at 1 Hz on the right DLPFC for 6 weeks
DEVICE	Placebo TCS	Inactive TCS (placebo coil) at 1 Hz on right DLPFC for 6 weeks
DRUG	nicotine treatment	at least 21/14/7 mg/d + oral nicotine cp from 2 to 30 mg/d)
OTHER	Questionnaires	EVA on "craving", TCQ, QSU, BDI-II, CO tester, IGT, BART

Timeline

• Start date: 2020-06-29
• Primary completion: 2022-10-07
• Completion: 2022-10-07
• First posted: 2020-10-19
• Last updated: 2024-02-22

Locations

1 site across 1 country: France