EUCTR2019-004740-30-FR进行中（未招募）1 期
Cannabidiol for reducing drinking in alcohol use disorder and modifying the effects of alcohol on the brain and the liver: a phase 2 clinical trial. - The CARAMEL Study
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 76
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •Being aged 18 years, or more
- •Being fluent in French
- •Having read the information procedure and signed the informed consent sheet.
- •Being affiliated with health insurance.
- •DSM-5 criteria for AUD (all stages) (American Psychiatric Association, 2013)
- •Average drinking level of at least 12 standard-drinks (120g of ethanol) per day over the month prior to inclusion (i.e., a total alcohol consumption of 336 standard-drinks during the 28-day assessment period prior to inclusion), using the A-TLFB.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 76
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 76
排除标准
- •At least one day of abstinence (no alcohol drinking) during the month prior to inclusion
- •Criteria for liver cirrhosis (Child-Pugh B or C)
- •DSM-5 criteria for schizophrenia, schizoaffective disorder, or bipolar disorder, using the MINI 7.0.2.
- •Current suicidality, using the MNI 7.0.2
- •Current DSM-5 criteria for substance use disorder (other than alcohol or nicotine) using the MINI 7.0.2.
- •Any detected use of cannabis or any other cannabinoid within 60 days prior to screen
- •Lifelong history of cannabis use disorder (DSM-5 criteria)
- •Patients with transaminase elevations greater than 3 times upper the limit of normal and bilirubin greater than 2 times upper the limit of normal.
- •Impaired medical condition (investigator's decision)
- •Pregnancy, lactation, or insufficient contraceptive measure (precautionary measure) (See 5.2 for acceptable birth control methods)
- •Patients with cancer, HIV, pulmonary arterial hypertension, epilepsy.
- •Patients receiving acamprosate, naltrexone, disulfiram, nalmefene, topiramate, baclofen for AUD within 30 days prior to screening.
- •MRI contraindication: pacemaker, insulin pump, heart metal valve, cochlear implant…
- •Known hypersensitivity to the active principle (cannabidiol) or excipients (sucralose, menthol, mannitol).
- •Person under tutorship.
研究者
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