2024-517751-13-01招募中2 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
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 76
- 试验地点
- 4
- 主要终点
- The primary endpoint will be the total consumption of alcohol (in standard-drinks, sd) in the 28 last days (week 8 to week 12) of the study, using the A-TLFB daily self-report of alcohol drinking. The difference between the total alcohol consumption during 28 days preceding the study, and the 28 last days of the study, will be compared between the two groups.
研究概览
简要总结
The primary objective of the CARAMEL study is to compare the reduction in alcohol drinking between CBD and placebo (PCB), in a population of patients with AUD and heavy drinking level at baseline (i.e., 12 standard drinks (sd)/day or more). The drinking reduction level will be defined by the total consumption in the 28 days prior to inclusion, minus the total consumption of the 28 last days of the study (weeks 8 to 12).
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
- •Being aged 18 years, or more
- •Comprendre le français
- •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
排除标准
- •At least one day of abstinence (no alcohol drinking) during the month prior to inclusion
- •Pregnancy, lactation, or insufficient contraceptive measure (precautionary measure) (See 5.2 for acceptable birth control methods)
- •Patients with cancer, HIV, pulmonary arterial hypertension, epilepsy and with rifampicin, St. John’s wort, everolimus, tacrolimus or triazole antifungal agents like posaconazole, fluconazole.
- •History of vascular accident and/or cardiac arrhythmias and/or myocardial infarction
- •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
- •Person under tutorship or curatorship
- •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
- •Lifelong history of suicide attempts
- •Lifelong history or 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
- •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)
结局指标
主要结局
The primary endpoint will be the total consumption of alcohol (in standard-drinks, sd) in the 28 last days (week 8 to week 12) of the study, using the A-TLFB daily self-report of alcohol drinking. The difference between the total alcohol consumption during 28 days preceding the study, and the 28 last days of the study, will be compared between the two groups.
The primary endpoint will be the total consumption of alcohol (in standard-drinks, sd) in the 28 last days (week 8 to week 12) of the study, using the A-TLFB daily self-report of alcohol drinking. The difference between the total alcohol consumption during 28 days preceding the study, and the 28 last days of the study, will be compared between the two groups.
次要结局
- Difference (i.e., inclusion minus end of study) in CAP scores using ultra-sound electrography.
- Difference (i.e., inclusion minus end of study) in steatosis score using MRI morphometric assessment of fat composition of the liver.
- Difference (i.e., inclusion minus end of study) in steatosis score using SRM assessment of lipid peaks in the liver.
- Brain map of difference (i.e., inclusion minus end of study) in grey matter volumes in corticostriatal-limbic circuits.
- Brain difference (i.e., inclusion minus end of study) in cortical thickness of insula, superior temporal gyrus, dorso-lateral prefrontal cortex and anterior cingulate cortex.
- Difference (i.e., inclusion minus end of study) in attentional, memory and executive functions abilities using neuropsychological testing.
- Percentages of heavy drinking days (i.e., 6 standard-drinks or more) during the study period.
- Difference (i.e., inclusion minus end of study) in alcohol craving scores using the OCDS.
- Difference (i.e., inclusion minus end of study) in alcohol use disorder scores using the AUDIT-C.
- Difference (i.e., inclusion minus end of study) in GGT levels.
- Difference (i.e., inclusion minus end of study) in CDT levels.
- Difference (i.e., inclusion minus end of study) in PEth levels.
- Difference (i.e., inclusion minus end of study) in self-confidence to resist, quality of life (SF12v2), stigmatization, sleep quality (PSQI) scores.
- Difference (i.e., inclusion minus end of study) in anxiety and depression (HADS) scores.
研究者
VIAL Véronique
Scientific
Centre Hospitalier Le Vinatier
研究点 (4)
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