Double-blind, Randomised, Parallel-group, Three-arm, Dose Range, Placebo-controlled, Proof-of-concept Study to Evaluate the Efficacy, Tolerability and Safety of a Combination of Cypropheptadine and Prazosin on Alcohol Consumption in Patients With Severe Alcohol Use Disorder
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 154
- 试验地点
- 35
- 主要终点
- Change in the mean quantity of alcohol consumed per day in the three groups
研究概览
简要总结
Double-blind randomised, parallel-group, three-arm, multicentre, placebo-controlled study The primary objective is to demonstrate the superiority of the combination of Periactine® (cyproheptadine 8 mg/day or 12 mg/day) and Alpress® (prazosin 5 mg/day or 10 mg/day) over placebo on the reduction of the total alcohol consumption (TAC), in alcohol-dependent patients.
180 patients will be randomised into the two treatment groups (N=60 in the low-dose group and N=60 in the high-dose group) and the placebo group (N=60).
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
- Double (Participant, Investigator)
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
- •Severe alcohol use disorder
- •High-risk alcohol consumption
排除标准
- •Patient with orthostatic hypotension
- •Patient with hypotension
- •History of uncontrolled hypertension
- •Patient at risk for urinary retention associated with urethroprostatic disorders
- •Patient with a clinically-active malignancy
- •Patient with a confirmed cirrhosis
- •History of bronchial asthma
- •History of uncontrolled hyperthyroidism
- •History of cardiovascular disease not under control
- •Severe psychiatric disorder
- •History of alcohol withdrawal syndrome
研究组 & 干预措施
Low-dose group
Periactine® (Cyproheptadine 8 mg/day; two times 4 mg: morning and evening) and Alpress® (5 mg once a day slow-release: evening administration).
干预措施: Cyproheptadine (Drug)
Low-dose group
Periactine® (Cyproheptadine 8 mg/day; two times 4 mg: morning and evening) and Alpress® (5 mg once a day slow-release: evening administration).
干预措施: Alpress LP (Drug)
High-dose group
Periactine® (Cyproheptadine 12 mg/day; three times 4 mg: morning, noon and evening) and Alpress® (10 mg [2 tablets of 5 mg] once a day slow-release: evening administration)
干预措施: Cyproheptadine (Drug)
High-dose group
Periactine® (Cyproheptadine 12 mg/day; three times 4 mg: morning, noon and evening) and Alpress® (10 mg [2 tablets of 5 mg] once a day slow-release: evening administration)
干预措施: Alpress LP (Drug)
Placebo group
Placebo of Periactine® (three times per day: morning, noon and evening) and placebo of Alpress® (once a day: evening)
干预措施: Cyproheptadine (Drug)
Placebo group
Placebo of Periactine® (three times per day: morning, noon and evening) and placebo of Alpress® (once a day: evening)
干预措施: Alpress LP (Drug)
结局指标
主要结局
Change in the mean quantity of alcohol consumed per day in the three groups
时间窗: weeks 9 to 12
次要结局
未报告次要终点