BACLOFEN FOR IMPROVING BENZODIAZEPINE TITRATION IN BENZODIAZEPINE DEPENDENCE. BABET

INTERVENTION: Product Name: Cellulose microcristalline,Product Code: N/A,Pharmaceutical Form: N/A,Other descriptive name: N/A,Strength: N/A,Pharmaceutical form of the placebo: N/A,Product Name: ‐,Product Code: N05BA,Pharmaceutical Form: ,Other descriptive name: ,Strength: ‐,Product Name: ‐,Product Code: N05CD,Pharmaceutical Form: ,Other descriptive name: ,Strength: ‐,Product Code: SCP8937441,Pharmaceutical Form: ,Other descriptive name: ,Product Code: SCP148981,Pharmaceutical Form: ,Other descriptive name: ,Product Code: SCP877434,Pharmaceutical Form: ,Other descriptive name: CONDITION: MedDRA version: 21.1Level: LLTClassification code: 10004477Term: Benzodiazepine dependentSystem Organ Class: 10037175 Psychiatrics disorders, addictology ; MedDRA version: 21.1Level: LLTClassification code: 10004477Term: Benzodiazepine dependentSystem Organ Class: 10037175 Therapeutic area: Psychiatry and Psychology [F] ‐ Behavioral Disciplines and Activities [F04] PRIMARY OUTCOME: Main Objective:To assess the efficacy of baclofen, compared to placebo, in reducing benzodiazepine doses in patients with benzodiazepine use disorder Primary end point(s):Difference in total benzodiazepine consumption, in mg‐diazepam, between the 28 days before inclusion in the clinical trial and the last 28 days the last 28 days before visit 5 on Day 62/64 of randomisation Secondary Objective:To assess the safety of baclofen in reducing benzodiazepine doses in patients with benzodiazepine use disorder,To assess the efficacy of baclofen on increasing the frequency of discontinuation of benzodiazepine use after 4 months,To assess the efficacy of baclofen on quality of sleep, symptoms of anxiety, symptoms of depression, quality of life, craving and withdrawal symptoms. SECONDARY OUTCOME: Secondary end point(s):Craving score assessed by the Visual Analog Scale (VAS), Anxiety symptoms assessed by the State Trait Inventory Anxiety (STAI‐Y), Depression score assessed by the Montgomery‐Åsberg Depression Rating Scale (MADRS), Subjective sleep quality assessed by the Pittsburgh Sleep Quality Inde X(PSQI), Quality of life (SF‐12 v2). Secondary end point(s):Frequency of benzodiazepine discontinuation at the last visit of the treatment period (self‐report and urine test); Benzodiazepine withdrawal severity score assessed by the Clinical Institute Withdrawal Assessment of Benzodiazepine (CIWA‐B) Secondary end point(s):Frequency of serious and non‐serious adverse events of special interest, and frequency of all‐cause study discontinuations. INCLUSION CRITERIA: Patients aged = 18 years to = 65 years,For women of childbearing potential : negative pregnancy test at inclusion and use of effective contraception which will be continued throughout the trial period and agrees to carry out pregnancy tests throughout the trial period.,benzodiazepine use disorder (BUD) of any severity defined according to Diagnostic and Statistical Manual of Mental Disorders (DSM) 5 criteria,Average daily benzodiazepine dosage between 50 mg and 200mg‐diazepam (according to Ashton equivalence table) over the 28 days prior to inclusion. Benzodiazepine equivalents (zolpidem, zopiclone and eszopiclone) will be counted as part of the total equivalent daily dose of diazepam and will also be included in the tapering procedure,Continued use of benzodiazepines for more than 12 weeks,At least one history of BUD treatment failure. A treatment failure is defined as a failure to withdraw from the full dose (i.e., discontinuation of benzodiazepine and related pre