BACLOFEN for Benzodiazepine use disorder | Benzodiazepine dependence

Inclusion criteria

• {"criterion_text":"- Patients aged ≥ 18 years to ≤ 65 years\n- 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.\n- benzodiazepine use disorder (BUD) of any severity defined according to Diagnostic and Statistical Manual of Mental Disorders (DSM) 5 criteria\n- Average daily benzodiazepine dosage between 30 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\n- Continued use of benzodiazepines for more than 12 weeks\n- 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\n- Patient affiliated to a social security system\n- Patient capable of giving free, informed and written consent\n- Patient with or without guardianship"}

Exclusion criteria

• {"criterion_text":"- Cirrhosis of the liver\n- Non-compatible health conditions (at the discretion of the investigator)\n- 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)\n- Suicidal state assessed by the RUD (Risk Danger Urgency) test\n- Dependence on substances or drugs other than benzodiazepines and nicotine\n- History of baclofen use for all indications\n- 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\n- Pregnant or nursing women\n- Hypersensitivity to baclofen or microcrystalline cellulose\n- Participants under guardianship\n- Patients who need to drive and/or use machines during the 1-week dose escalation phase\n- Patients with significant medical conditions such as cancer, HIV, epilepsy, chronic respiratory failure, renal failure, etc.\n- Patients with a history of cerebrovascular disease, gastric or duodenal ulcers and Parkinson's disease\n- Patients with porphyria"}

Primary endpoints

• {"endpoint_text":"- 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","definition_or_measurement_approach":"Measured as the difference in total benzodiazepine consumption expressed in mg-diazepam equivalents between the 28-day period prior to inclusion and the 28-day period before visit 5 (Day 62/64). Diazepam equivalence conversion (Ashton table) is specified elsewhere in the protocol for dose conversion."}

Secondary endpoints

• {"endpoint_text":"- Frequency of serious and non-serious adverse events of special interest, and frequency of all-cause study discontinuations.","definition_or_measurement_approach":"Safety endpoints captured as frequency counts of serious and non-serious adverse events of special interest and counts of study discontinuations for any cause."}
• {"endpoint_text":"- 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)","definition_or_measurement_approach":"Benzodiazepine discontinuation assessed by participant self-report and urine testing; withdrawal severity measured using the CIWA-B scale."}
• {"endpoint_text":"- 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).","definition_or_measurement_approach":"Patient-reported and clinician-rated scales: craving by VAS; anxiety by STAI-Y; depression by MADRS; sleep by PSQI; quality of life by SF-12 v2."}

France

Earliest CTIS Part Ii Submission Date

15-12-2023

Latest Decision Or Authorization Date

15-04-2026

Processing Time Days

852

Number Of Sites

2

Number Of Participants

93

Primary sponsor

Full Name

Hospices Civils De Lyon

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

France