BACLOFEN FOR IMPROVING BENZODIAZEPINE TITRATION IN BENZODIAZEPINE DEPENDENCE. BABET - 69HCL21_1318

Hospices Civils De Lyon0 个研究点目标入组 93 人开始时间: 2023年11月6日最近更新: 2024年7月22日

试验速览

暂无简介。

•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 prescriptions) according to a previously established tapering schedule, by a general practitioner or specialist, Patient affiliated to a social security system, Patient capable of giving free, informed and written consent, Patient with or without guardianship

•Cirrhosis of the liver, Participants under guardianship, Patients who need to drive and/or use machines during the 1-week dose escalation phase, Patients with significant medical conditions such as cancer, HIV, epilepsy, chronic respiratory failure, renal failure, etc., Patients with a history of cerebrovascular disease, gastric or duodenal ulcers and Parkinson's disease, Patients with porphyria, Non-compatible health conditions (at the discretion of the investigator), The following psychiatric conditions as defined by DSM-5 criteria: schizophrenic disorder, persistent delusional disorder, schizophreniform disorder, schizoaffective disorder, bipolar disorder, autism spectrum disorder identified using the Mini International Neuropsychiatric Interview version 7.0.2 (MINI 7.0.2), Suicidal state assessed by the RUD (Risk Danger Urgency) test, Dependence on substances or drugs other than benzodiazepines and nicotine, History of baclofen use for all indications, Unauthorized combination therapies will be: pregabalin, topiramate, ketamine, sodium oxybate, gabapentin, valproic acid, sodium valproate, melatonin, buspirone, hydroxyzine, propranolol, bisoprolol, etifoxin, carbamazepine, clonidine, paroxetine, all neuroleptic/antipsychotic class therapies, and tricyclic antidepressants, Pregnant or nursing women, Hypersensitivity to baclofen or microcrystalline cellulose

发起方