RecruitingNot ApplicableNCT04773691

Effectiveness of High-frequency rTMS in Reducing Alcohol Consumption in Non-abstinent Patients With an Alcohol Use Disorder

Effectiveness of High-frequency rTMS in Reducing Alcohol Consumption in Non-abstinent Patients With an Alcohol Use Disorder: A Multicentre Randomised Controlled Study


Sponsor

Centre Hospitalier Universitaire Dijon

Enrollment

144 participants

Start Date

Mar 1, 2021

Study Type

INTERVENTIONAL

Conditions

Summary

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a medical device called Active rTMS, a medical device called Breathalyzer, and others for people with alcoholism and rtms stimulation. The study is currently recruiting participants at 1 location.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICEActive rTMS

Two rTMS stimulation sessions spaced 15 minutes apart are delivered daily for 5 consecutive days. A total of 10 sessions. Stimulation parameters: 10 Hz, 1000 pulses per session, 110% of SM, cortical target: right DLPFC

DEVICEPlacebo rTMS

Two rTMS stimulation sessions spaced 15 minutes apart are delivered daily for 5 consecutive days. A total of 10 sessions. Stimulation parameters: delivering a non-significant current at the beginning and end of the stimulation, simulating active stimulation.

OTHERQuestionnaires

questionnaires for craving assessment: EVA, OCDS, CGI and ADS and signs of physical withdrawal by CIWA

DEVICEBreathalyzer

estimation of blood alcohol level


Locations(1)

Chu Dijon Bourogne

Dijon, France

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NCT04773691


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