Actively Recruiting
Effectiveness of High-frequency rTMS in Reducing Alcohol Consumption in Non-abstinent Patients With an Alcohol Use Disorder
Led by Centre Hospitalier Universitaire Dijon · Updated on 2025-04-17
144
Participants Needed
1
Research Sites
334 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The fight against alcoholism is a public health priority. Around 15 million Europeans and 10 million North Americans are alcohol dependent. Worldwide, 1 death out of 25 is thought to be attributed to alcohol. In France, the latest published data on alcohol-related mortality indicates that there were 49,000 alcohol-related deaths in 2009. Alcohol is thought to be the leading cause of hospitalisation for French people, and its social cost is estimated at 37.4 billion euros. However, few patients with an alcohol use disorder are treated: less than 8% in Europe and less than 10.5% in the USA receive appropriate treatment for their alcohol problem. This low rate of treatment is mainly due to the fact that these patients are not ready to stop drinking. They are therefore not attracted by the goal of abstinence that is required by most current therapies and drug treatments. The arrival of new treatments aimed at reducing consumption (rather than abstinence) should make treatment more attractive. To date, nalmefen is the only treatment marketed for this indication. Baclofen should be marketed in 2020, but with restrictive prescription criteria. In this new strategy to reduce consumption, brain stimulation could play a predominant role as an alternative or complementary therapy. Indeed, functional brain imaging techniques have made it possible to visualise the cortical regions involved in craving, in particular the dorsolateral prefrontal cortex (DLPFC). Craving, i.e. the irrepressible desire to consume, is often at the origin of consumption and relapse. Stimulation of the dorsolateral prefrontal cortex with non-invasive cerebral stimulation techniques, such as repeated transcranial magnetic stimulation (rTMS), has provided encouraging results for the reduction of cravings in all addictive behaviours (alcohol, tobacco, cocaine, food). Furthermore, stimulation of the DLPFC seems to modulate decision-making processes: it may thus reduce impulsivity and strengthen inhibitory control, leading to a reduction in substance use. The hypothesis to be tested is that repeated transcranial magnetic stimulation allows a reduction in alcohol consumption in patients with an alcohol use disorder.
CONDITIONS
Official Title
Effectiveness of High-frequency rTMS in Reducing Alcohol Consumption in Non-abstinent Patients With an Alcohol Use Disorder
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Person who has given free, written informed consent
- Adult patient
- Patient with mild to severe alcohol use disorder according to DSM-5 criteria
- Voluntary patient willing to reduce alcohol consumption
- Patient who has made at least one previous attempt at alcohol withdrawal or reducing consumption
You will not qualify if you...
- Not affiliated with or beneficiary of national health insurance
- Under legal protection measures such as curatorship or guardianship
- Pregnant, parturient, or breastfeeding women
- Adult unable to give consent
- Female patient of childbearing age with positive pregnancy test at inclusion
- Patient with exhaled alcohol level greater than 0 milligrams/litre
- Patient with heavy alcohol consumption less than 6 days in the 4 weeks before inclusion
- Patient with average alcohol consumption below WHO average risk level in the 4 weeks before inclusion
- Patient abstinent more than 5 days before inclusion
- Patient with CIWA score 10 or higher at inclusion
- Patient treated with disulfiram, acamprosate, topiramate, baclofen, naltrexone, or nalmefen in the past month
- Patient with history or presence of pre-delirium tremens or delirium tremens
- Patient with substance use disorder other than tobacco and alcohol
- Patient with acute psychiatric disorders needing hospitalization or immediate medication adjustment
- Patient with severe depression (HAM-D score 24 or more)
- Patient with recent change in psychotropic medication (less than 1 month)
- Patient with severe or chronic psychiatric disorders including schizophrenia, paranoia, bipolar I or II
- Patient with severe heart, kidney, liver, or lung failure or other conditions compromising study participation
- Patient with contraindications to rTMS such as pacemaker, neurosurgical clips, certain implants, or metallic foreign bodies in the head
- Patient currently in another therapeutic trial
- Patient employed by investigator or trial site
- Patient unable to complete consumption diary and follow-up visits for 6 months
- Patient refusing to sign the study-specific safety contract
AI-Screening
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Trial Site Locations
Total: 1 location
1
Chu Dijon Bourogne
Dijon, France, 21000
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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