Effectiveness of Transcranial Magnetic Stimulation (TMS) in Smoking Cessation, Combining Withdrawal Stimulation Followed by Maintenance Stimulation to Prevent Relapse. — TabacStim2

Smoking Cessation Clinical Trial

Official title:
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

Clinical Trial 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.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT04591743
Study type	Interventional
Source	Centre Hospitalier Universitaire Dijon
Contact
Status	Completed
Phase	N/A
Start date	June 29, 2020
Completion date	October 7, 2022

View Details

See also
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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.