2023-506990-37-00招募中3 期
Efficacy and safety of Sodium Oxybate in reducing alcohol consumption and maintaining abstinence in alcohol-dependent subjects with high and very high drinking risk level
Laboratorio Farmaceutico C.T. S.r.l., Laboratorio Farmaceutico C.T. S.r.l.16 个研究点 分布在 3 个国家目标入组 101 人开始时间: 2023年9月29日最近更新:
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 101
- 试验地点
- 16
- 主要终点
- The primary end point of the study is the reduction of HDDs as measured by the average number of HDDs after 3 months of treatment (Visit 7, week 12).
研究概览
简要总结
The primary objective of the present study is to demonstrate the efficacy of Sodium Oxibate in reducing the alcohol consumption of alcohol-dependent Subjects with HDRL and VHDRL, as measured by the number of HDDs.
入排标准
- 年龄范围
- 18 years 至 65+ years（65+ Years, 18-64 Years）
- 接受健康志愿者
- 是
入选标准
- •The study population will be enrolled among alcohol-dependent Subjects afferent to the centers. Alcohol-dependent Subjects regular drinkers of alcoholic beverages, with HDRL and VHDRL of alcohol consumption, naïve for Alcover treatment high-risk alcohol consumption will be considered for the enrolment in the present study. All the below inclusion criteria must be fulfilled at Visit 1, by each Subject to be included in the trial:
- •Signature of Informed Consent for the study and for treatment of personal data
- •Male or female of any ethnic group between 18- and 70 -years old
- •Body weight between 60 and 100 kg with a BMI＜ 40
- •Current diagnosis of alcohol use disorder according to the DSM-5
- •High or very high DRL of alcohol consumption based on WHO criteria (HDRL:> 60 g / day in males and> 40 g / day in females; VHDRL:> 100 g / day in males and> 60 g / day in females)
- •No or mild alcohol withdrawal symptoms, defined as CIWA-Ar score < 10
- •Medical conditions compatible with the safe enrollment as confirmed by medical history and physical examination
- •At least 4 HDDs per week in the 4 weeks prior to the screening visit
- •Ability/possibility to efficacy fill in the TFLB and study administered scale
- •Ability/possibility to assume the study drug/placebo
- •Subjects with cirrhosis only: compensated medical condition determined based on the clinical evaluation and psychometric assessment as measured using ANT1 (cut-off value >15)
- •Females only: postmenopausal for at least one year, surgically sterile, or practicing an effective method of birth control before entry, throughout the study, and for two months after the end of treatment
排除标准
- •A Subject who met at least one of the following conditions is not eligible and should not be addressed to randomization and treatment phase:
- •Use of Sodium Oxybate during the three months prior to randomitation
- •Current diagnosis of substance dependence other than alcohol and nicotine
- •Lifetime diagnosis of schizophrenia, bipolar disorders, or other psychoses; lifetime diagnosis of Major Depression and history of attempted suicide.
- •History of epilepsy or alcohol-related seizures
- •Positive urine test for cocaine, opiates, methadone at any time during the study.
- •Current participation to another study or participation to an interventional study conducted during 3 months prior to randomization.
- •Females only: breast-feeding and/or positive urine pregnancy test at any time during the study.
- •Severe diseases and/or medical conditions, both acute and chronic, which in the opinion of the investigator jeopardize patient safety, including respiratory depression, liver diseases (e.g. acute hepatitis), decompensated cirrhosis.
- •Presence of particular social condition that, at the investigator judgement, may interfere with the proper study conduct (i.e. subject social marginalisation, Homeless condition, known history of previous crimes related to sexual abuse, drug dealing, etc)
- •Patients with porphyria
- •History of current epileptic syndrome with the exception of neonate convulsions. Patients with epileptic episodes due to alcohol withdrawal are also excluded
- •Known medical history of succinic semialdehyde dehydrogenase deficiency
- •Any significant cerebral vascular and/or cardiovascular disease (e.g., unstable angina pectoris at rest or for minimal effort, acute myocardial infarction within the last 3 months, hearth failure NYHA class II-IV)
- •Any neurological or psychiatric disorders resulting in disorientation, memory impairment, inability to report accurately (for instance Alzheimer’s disease and any other dementia)
- •Concomitant use of psychotropic medications including antiepileptic agents that cannot be discontinued; any medication that may have an effect on alcohol consumption, including baclofen, naltrexone, acamprosate, nalmefene, alcohol dehydrogenase inhibitors, topiramate, gabapentin, ondansetron, benzodiazepines, opioid analgesics, dopamine/norephinefrine reuptake inhibitors.
- •Subjects requiring a structured psychotherapy
- •Hypersensitivity to the active substance or to any of the excipients.
- •Female subjects not willing to undergo to an adequate contraception method for the study duration.
结局指标
主要结局
The primary end point of the study is the reduction of HDDs as measured by the average number of HDDs after 3 months of treatment (Visit 7, week 12).
The primary end point of the study is the reduction of HDDs as measured by the average number of HDDs after 3 months of treatment (Visit 7, week 12).
次要结局
未报告次要终点
研究者
Benedetta Porro
Scientific
Laboratorio Farmaceutico C.T. S.r.l.
研究点 (16)
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