2022-502307-30-00招募中3 期
BACLOFEN FOR IMPROVING BENZODIAZEPINE TITRATION IN BENZODIAZEPINE DEPENDENCE. BABET
干预措施
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 93
- 试验地点
- 2
- 主要终点
- 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
研究概览
简要总结
To assess the efficacy of baclofen, compared to placebo, in reducing benzodiazepine doses in patients with benzodiazepine use disorder
研究设计
- 分配方式
- Randomized
- 主要目的
- Baclofen Winner Arm/Placebo
- 盲法
- Double (Subject, Monitor, Investigator)
入排标准
- 年龄范围
- 18 years 至 64 years（18-64 Years）
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
-
Auxiliary
Participants receiving -
干预措施: - (Drug)
结局指标
主要结局
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
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
次要结局
- Frequency of serious and non-serious adverse events of special interest, and frequency of all-cause study discontinuations.
- 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)
- 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).
研究者
Pr Benjamin ROLLAND
Scientific
Hospices Civils De Lyon
研究点 (2)
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