Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
ID04773691

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

Led by Centre Hospitalier Universitaire Dijon · Updated on 2025-04-17

144

Participants Needed

1

Research Sites

N/A

Total Duration

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AI-Summary

What this Trial Is About

Alcoholism is a major public health concern affecting millions worldwide, with significant mortality and social costs. Despite this, only a small percentage of people with alcohol use disorder receive appropriate treatment, often because they are not ready to stop drinking completely. This study is investigating whether repeated transcranial magnetic stimulation (rTMS) targeting the brain's dorsolateral prefrontal cortex can help reduce alcohol consumption in patients who are not abstinent but wish to decrease their drinking. Participants will be randomly assigned to receive either active or placebo rTMS. The active treatment involves daily sessions of high-frequency stimulation (10 Hz, 1000 pulses per session) delivered twice a day for five consecutive days, targeting the right dorsolateral prefrontal cortex. The placebo group will receive sham stimulation mimicking the procedure without significant brain stimulation. The study aims to compare the effects of these treatments on alcohol consumption and craving. During the study, participants will complete questionnaires assessing craving and withdrawal symptoms and undergo breathalyzer tests to estimate blood alcohol levels. Researchers will monitor total alcohol intake and the number of high-consumption days over about one month. The study includes safety assessments and follow-up visits, with a total participation period extending to six months. This randomized, double-blind trial is led by Centre Hospitalier Universitaire Dijon and started in March 2021, continuing until August 2027.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Provided free, written, and informed consent
  • Adult patient
  • Diagnosed with mild to severe alcohol use disorder according to DSM-5 criteria
  • Willing to reduce alcohol consumption
  • Has previously attempted alcohol withdrawal or reduction (with failure or relapse)
Not Eligible

You will not qualify if you...

  • Not covered by national health insurance
  • Under legal protection measures (curatorship, guardianship, or safeguard)
  • Pregnant, breastfeeding, or parturient women
  • Unable to provide informed consent
  • Positive pregnancy test at inclusion
  • Exhaled alcohol level above 0 mg/l at inclusion
  • Heavy alcohol consumption on fewer than 6 days in the 4 weeks before inclusion
  • Average alcohol consumption below WHO average risk level in the 4 weeks before inclusion
  • Abstinent for more than 5 days before inclusion
  • CIWA score 10 or higher at inclusion
  • Current treatment with disulfiram, acamprosate, topiramate, baclofen, naltrexone, or nalmefen within 1 month
  • History or presence of pre-delirium tremens or delirium tremens
  • Substance use disorder other than tobacco and alcohol
  • Acute psychiatric disorders needing hospitalization or immediate medication changes
  • Severe depression (HAM-D score 24 or more)
  • Recent change in psychotropic medication within 1 month
  • Severe or chronic psychiatric disorders including schizophrenia, paranoia, and bipolar disorder types I and II
  • Severe heart, kidney, liver, or lung failure or other conditions risking study participation
  • Contraindications to rTMS such as seizures, pacemaker, neurosurgical clips, metallic implants, or ferromagnetic materials in the head
  • Participation in another therapeutic trial
  • Employee of the investigator or trial site
  • Unable to complete consumption diary and follow-up visits for 6 months
  • Refusal to sign the study's safety contract

AI-Screening

AI-Powered Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Implementation

Duration - 5 days

Participants receive daily rTMS stimulation sessions, consisting of two sessions spaced 15 minutes apart, delivered for 5 consecutive days.

Daily visits for 5 days

Follow-up

Duration - Approximately 1 month

Participants are followed for approximately 1 month to assess alcohol consumption and craving through questionnaires and breathalyzer measurements.

1 baseline visit and multiple follow-up visits during the month

Trial Site Locations

Total: 1 location

1

Chu Dijon Bourogne

Dijon, France, 21000

Actively Recruiting

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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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Published Research Related To This Trial

Efficacy of repetitive transcranial magnetic stimulation (rTMS) for reducing consumption in patients with alcohol use disorders (ALCOSTIM): study protocol for a randomized controlled trial.

Benjamin Petit, Agnès Soudry-Faure, Ludovic Jeanjean...

https://pubmed.ncbi.nlm.nih.gov/35022086