Ignite Creation Date:
2024-05-06 @ 3:20 PM
Last Modification Date:
2024-10-26 @ 1:47 PM
Study NCT ID:
NCT04591743
Status:
COMPLETED
Last Update Posted:
2024-02-22
First Post:
2020-10-12
Brief Title:
Effectiveness of Transcranial Magnetic Stimulation TMS in Smoking Cessation Combining Withdrawal Stimulation Followed by Maintenance Stimulation to Prevent Relapse
Sponsor:
Centre Hospitalier Universitaire Dijon
Organization:
Centre Hospitalier Universitaire Dijon
Study Overview
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
Status Verified Date:
2024-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
TabacStim2
Brief Summary:
Tobacco control is a Public Health priority Tobacco is directly responsible for 75000 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 888 active TCS group vs 50 placebo TCS group p0027
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
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 888 active TCS group vs 50 placebo TCS group p0027
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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None