BACLOFEN FOR IMPROVING BENZODIAZEPINE TITRATION IN BENZODIAZEPINE DEPENDENCE. BABET

Phase 1

Conditions: Psychiatrics disorders, addictology
MedDRA version: 21.1Level: LLTClassification code: 10004477Term: Benzodiazepine dependent Class: 10037175
Therapeutic area: Psychiatry and Psychology [F] - Behavioral Disciplines and Activities [F04]

Registration Number: CTIS2022-502307-30-00

Lead Sponsor: Hospices Civils De Lyon

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 93

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 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

Exclusion Criteria

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

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To assess the efficacy of baclofen, compared to placebo, in reducing benzodiazepine doses in patients with benzodiazepine use disorder;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.;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 Outcome Measures

Name	Time	Method
Secondary end point(s):Frequency of serious and non-serious adverse events of special interest, and frequency of all-cause study discontinuations.;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):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 Index (PSQI), Quality of life (SF-12 v2).

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