2023-504439-42-01撤回2 期
Phase II, Placebo-controlled trial of Cannabidiol for the treatment of alcohol dependence (PLACONCANALDE)
Hospital Universitario 12 De Octubre1 个研究点 分布在 1 个国家目标入组 118 人开始时间: 2025年9月30日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 发起方
- 入组人数
- 118
- 试验地点
- 1
- 主要终点
- To evaluate CBD efficacy on alcohol dependance
研究概览
简要总结
Determine the change in the Timeline Follow-back (TLFB) assessment of alcohol consumption and the change in percent Carbohydrate Deficient Transferrin (CDT) in serum, to evaluate the therapeutic potential of CBD in the management of patients with alcohol dependence who are seeking treatment to achieve abstinence.
入排标准
- 年龄范围
- 18 years 至 64 years（18-64 Years）
- 接受健康志愿者
- 是
入选标准
- •Males and females aged 18-65
- •DSM-5 diagnosis of moderate or severe AUD.
- •Able to provide voluntary informed consent.
- •At least 8 heavy drinking days (4 or more drinks for a woman, 5 or more drinks for a man) in the 30 days prior to screen.
- •If of childbearing potential (male or female), are willing to use approved form of contraception from screening for duration of the trial.
- •Able to provide at least two locators.
- •Endorse desire to cut down or stop drinking.
- •Endorse desire to cut down or stop drinking.
排除标准
- •Current alcohol withdrawal (CIWA-Ar score >7).
- •Pregnancy or lactation.
- •Current use of exclusionary medications, including cannabinoids; treatments for addictions including alcohol; moderate to strong inhibitors of CYP3A4 or CYP2C19; medications metabolized primarily by CYP3A4, CYP3A5, or CYP3A7; and medications with a narrow therapeutic index which are substrates of UGT1A9, UGT2B7, CYP2C8, CYP2C9, CYP2C19, CYP1A2, or CYP2B
- •Allergy to any ingredient of the study compound.
- •Current treatment for AUD, with exception of AA/12-step treatment/mutual-help groups-.
- •No inpatient psychiatric treatment in the last 12 months, with the exception of detox and extended Emergency Department stays.
- •A positive urine drug screen for THC, cocaine and/or opioids at screen.
- •Exclusionary medical conditions (e.g., current severe alcohol withdrawal requiring medical hospitalization, significantly impaired liver function).
- •DSM-5 diagnosis of schizophrenia, schizoaffective disorder, bipolar disorder.
- •High risk of adverse emotional or behavioral reaction based on investigator's clinical evaluation (e.g., evidence of serious personality disorder, antisocial behavior, serious current stressors, lack of meaningful social support).
- •Current significant suicidality (assessed using the C-SSRS), any suicidal behavior in the past 12 months, or any history of serious suicide attempts requiring hospitalization, or current significant homicidally.
- •History of severe Traumatic Brain Injury (LOC > 24 hours).
- •DSM-5 diagnosis of current mild cannabis use disorder and/or moderate or severe substance use disorder for a substance other than alcohol or nicotine.
- •Significant laboratory abnormalities, including significantly impaired liver function, serious abnormalities of complete blood count or metabolic panel.
- •Active legal problems likely to result in incarceration within 12 weeks of treatment initiation.
结局指标
主要结局
To evaluate CBD efficacy on alcohol dependance
To evaluate CBD efficacy on alcohol dependance
To evaluate psychological symptoms involved in alcohol consumptions
To evaluate psychological symptoms involved in alcohol consumptions
To evaluate endocannabinoid system
To evaluate endocannabinoid system
To evaluate CBD tolerability and safety in alcohol dependents
To evaluate CBD tolerability and safety in alcohol dependents
次要结局
未报告次要终点
研究者
Gabriel Rubio Valladolid
Scientific
Hospital Universitario 12 De Octubre
研究点 (1)
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