Phase
Condition
Addictions
Alcohol Dependence
Alcohol Use Disorder
Treatment
Breathalyzer
Placebo rTMS
Active rTMS
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
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 orrelapse), or at reducing consumption
Exclusion
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 formen 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 40gfor women)
patient being abstinent more than 5 days before inclusion
patient with a CIWA (Clinical Institute Withdrawal Evaluation: assessment of theseverity 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 substancesother than tobacco and alcohol.
Patient with acute psychiatric disorders requiring hospitalization and/or immediateadjustment of psychotropic medication
Patient with severe depression, defined by a score of 24 or more on the HamiltonDepression Scale (HAM-D).
Patient who has had a recent change (< 1 month) in the prescription of psychotropictreatment
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 thedoctor believes could compromise the patient's participation in the study.
Patient with a contraindication to the practice of rTMS; personal history ofseizure, pacemaker, neurosurgical clips, carotid or aortic clips, heart valves,hearing aid, ventricular bypass valve, sutures with wires or staples, foreign bodiesin 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 consumptiondiary and follow up visits for 6 months
Patient refusing to sign the "safety contract "* specific to the study
Study Design
Connect with a study center
Chu Dijon Bourogne
Dijon, 21000
FranceActive - Recruiting
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