A Multisite Randomized Clinical Trial Evaluating BP1.3656 Vs Placebo For Alcohol Use Disorder Treatment
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Bioprojet
- 入组人数
- 210
- 试验地点
- 3
- 主要终点
- Decrease in number of monthly Heavy Drinking Days (HDDs/month)
研究概览
简要总结
A Multisite Randomized Clinical Trial Evaluating BP1.3656 Vs Placebo For Alcohol Use Disorder Treatment.
详细描述
Proof of concept study evaluating in alcohol use disorder, the ability of psychosocial support in combination with BP1.3656 to reduce alcohol consumption. The study will be a multicenter, randomized, double-blind, placebo-controlled phase II trial with parallel groups to evaluate the effectiveness and the safety of BP1.3656.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female alcohol use disorder
- •Ages 18-65
- •Absent or minimal alcohol withdrawal symptoms assessed
- •18 kg/m2 ≤ BMI ≤ 35 kg/m2
- •Excessive alcohol use during the 2 weeks between screening and baseline
- •Voluntarily expressed willingness to participate in the study, understanding protocol procedures and having signed and dated an informed consent prior to the start of protocol required procedures while not intoxicated (BAC<0.05).
排除标准
- •History of delirium tremens, epilepsy, or withdrawal seizures
- •Clinical depression or suicidality: Beck Depression Inventory (BDI) ≥ 16 and suicidality (Item G ≠ 0)
- •Recent illicit drug use, i.e. cannabis, cocaine, amphetamines or opioids
- •Clinically significant cardiovascular, hematologic, severe hepatic impairment
- •History of psychosis, or current severe psychiatric disorder, e.g. schizophrenia, bipolar disorder, severe depression or organic brain syndrome unrelated to alcohol abuse
- •Physical dependence on sedatives or hypnotics that requires pharmacologically supported detox
- •Receiving ongoing alcohol use disorder medication (e.g. Baclofen)
研究组 & 干预措施
BP1.3656 low dose
administration of BP1.3656 at 30 µg
干预措施: BP1.3656 low dose (Drug)
BP1.3656 intermediate dose
administration of BP1.3656 at 60 µg
干预措施: BP1.3656 intermediate dose (Drug)
Placebo
administration of placebo
干预措施: Placebo (Drug)
BP1.3656 high dose
administration of BP1.3656 at 90 µg
干预措施: BP1.3656 high dose (Drug)
结局指标
主要结局
Decrease in number of monthly Heavy Drinking Days (HDDs/month)
时间窗: 12 weeks
Decrease in number of monthly heavy drinking days (HDD/month) from baseline to the end of the double blind Randomized Treatment.
次要结局
- Total daily alcohol consumption (TAC)(12 weeks)
- Percent of patients without Heavy Drinking Days (HDDs)(12 weeks)