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

Launched by CENTRE HOSPITALIER UNIVERSITAIRE DIJON · Feb 24, 2021

Keywords

ClinConnect Summary

This clinical trial is investigating a new treatment approach for people struggling with alcohol use disorder, focusing on reducing alcohol consumption rather than requiring complete abstinence. The study uses a technique called repeated transcranial magnetic stimulation (rTMS), which is a non-invasive method that stimulates specific areas of the brain to help manage cravings and reduce impulsivity related to drinking. Researchers hope that by targeting the brain regions involved in cravings, this treatment can help patients cut down on their alcohol intake.

To participate in the trial, individuals must be adults aged 18 or older who have been diagnosed with mild to severe alcohol use disorder and are willing to reduce their drinking. Participants should have previously tried to cut back or quit drinking, even if they were not successful. Those who are pregnant, have severe psychiatric disorders, or certain medical conditions may not be eligible. If you choose to join, you will undergo rTMS sessions and will be asked to keep a diary of your alcohol consumption over six months. This study is important as it offers a potential new option for those who may not be ready to quit drinking entirely but want to make positive changes in their lives.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • a person who has given his or her free, written and informed consent
• • adult patient
• • patient with mild to severe alcohol use disorder according to DSM-5 criteria
• • voluntary patient to reduce alcohol consumption
• • patient who has already made at least one attempt at alcohol withdrawal (failure or relapse), or at reducing consumption
• Exclusion Criteria:
• • person who is not affiliated to or not a beneficiary of national health insurance
• • person subject to a legal protection measure (curatorship, guardianship)
• • person subject to a legal safeguard measure
• • pregnant, parturient or breastfeeding women
• • adult unable to express consent
• • patient of childbearing age with a positive pregnancy test at inclusion
• • patient with an exhaled alcohol level \> 0 milligrams/litre inclusive
• • patient with heavy alcohol consumption \< 6 days in the 4 weeks prior to inclusion (European Medicine Agency, 2010; one day with alcohol consumption of 60g or more for men and 40g for women)
• • patient with an average alcohol consumption below the WHO average risk level in the 4 weeks prior to inclusion (WHO, 2000, less than or equal to 40g/day for men and 40g for women)
• • patient being abstinent more than 5 days before inclusion
• • patient with a CIWA (Clinical Institute Withdrawal Evaluation: assessment of the severity of alcohol withdrawal) score greater than or equal to 10 at inclusion
• • Patient with concomitant treatment with disulfiram, acamprosate, topiramate, baclofen, naltrexone, and nalmefen (\< 1 month)
• • Patient with a history or presence of pre-delirium tremens or delirium tremens
• • Patient with a substance use disorder (DSM-5 criteria) with psychoactive substances other than tobacco and alcohol.
• • Patient with acute psychiatric disorders requiring hospitalization and/or immediate adjustment of psychotropic medication
• • Patient with severe depression, defined by a score of 24 or more on the Hamilton Depression Scale (HAM-D).
• • Patient who has had a recent change (\< 1 month) in the prescription of psychotropic treatment
• • Patient with severe and/or chronic psychiatric disorders, including schizophrenia, paranoia and bipolar disorders type I and II
• • Patient with severe heart, kidney, liver or lung failure or other condition that the doctor believes could compromise the patient's participation in the study.
• • Patient with a contraindication to the practice of rTMS; personal history of seizure, pacemaker, neurosurgical clips, carotid or aortic clips, heart valves, hearing aid, ventricular bypass valve, sutures with wires or staples, foreign bodies in the eye, shrapnel, other prosthesis or cephalic ferromagnetic material.
• • Patient simultaneously participating in another therapeutic trial
• • Patient employed by the investigator or trial site
• • Patient who, according to the investigator, is unable to complete a consumption diary and follow up visits for 6 months
• • Patient refusing to sign the "safety contract "\* specific to the study