Phase
Condition
Alcohol Use Disorder
Alcohol Dependence
Substance Abuse
Treatment
Placebo
Baclofen
Clinical Study ID
Ages 18-65 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Patient coming for a problem with alcohol (alcohol at high risk during the pastthree months (at least two times during each month) according to the WHO standards;.i.e.: in women more than 40 g per day or 280 g per week or more of 40 g at once; theman more than 60 g per day or 420 g per week or more than 60 g in once, andexpressing the desire to be abstinent or to have a consumption to low level ofrisk).
Volunteer to participate in the trial and having given his consent written afterappropriate information
Patient having no treatment for the maintenance of abstinence (acamprosate,naltrexone) and the prevention of relapse (disulfiram) for at least 15 days beforethe beginning of the trial
Patient informed about the possibility of drowsiness in relation to the treatmentand the associated risks to drive vehicles (motorized or not), the use of machines (including domestic use or recreation) and the execution of tasks requiringattention and precision
Including woman of childbearing age (but taking effective contraception).
Exclusion
Exclusion Criteria:
Patient taking already baclofen or having taken baclofen
Patient pregnant, lactating, or childbearing years in the absence of effectivecontraception
Patient with porphyria
Patient with Parkinson's disease
Patient with severe psychiatric pathology (psychosis, including schizophrenia andbipolar disorders) that can compromise the observance
Patient with organic disease serious enough to not to allow its inclusion in thestudy according to the opinion of the investigator
Patient homeless
Patient without social cover
Patient unable to properly follow-up book, cannot commit to one year of follow-up
Patient with a contraindication to taking baclofen (intolerance to gluten by thepresence of wheat starch
Patient with a severe intolerance known about the lactose
Study Design
Study Description
Connect with a study center
Paris Descartes University
Paris, 75014
FranceSite Not Available
Paris Descartes University
Paris 2988507, 75014
FranceSite Not Available

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