2023-506167-34-00撤回2 期
Improving inpatient GHB detoxification with baclofen: A proof of concept and dose-finding study.
Stichting Radboud University Medical Center2 个研究点 分布在 1 个国家目标入组 28 人开始时间: 2023年10月12日最近更新:
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 发起方
- 入组人数
- 28
- 试验地点
- 2
- 主要终点
- The main study parameter is pharmaceutical GHB dosage at the end of the titration phase during inpatient detoxification in patients with GUD
研究概览
简要总结
To assess whether the baclofen add-on therapy reduces the need for pharmaceutical GHB during inpatient detoxification in patients with GUD
入排标准
- 年龄范围
- 18 years 至 64 years（18-64 Years）
- 接受健康志愿者
- 否
入选标准
- •Diagnosed with GUD according to the DSM-V-TR criteria of substance use disorder
- •Indication for intramural GHB detoxification
- •GHB use >50ml/day
- •>18 years old
排除标准
- •Patients who has acute psychiatric co-morbidity that require immediate medical attention and interferes with the execution of the study, such as mania, delirium and psychosis
- •Physical contra-indications for baclofen
- •Body weight <55kg
- •Insufficient understanding of the Dutch language
- •GHB use >120ml/day
- •Comorbid benzodiazepine use >30mg diazepam equivalent per day
- •Use of antihypertensive drugs
- •Use of tricyclic antidepressant drugs
结局指标
主要结局
The main study parameter is pharmaceutical GHB dosage at the end of the titration phase during inpatient detoxification in patients with GUD
The main study parameter is pharmaceutical GHB dosage at the end of the titration phase during inpatient detoxification in patients with GUD
次要结局
未报告次要终点
研究者
Drs. Amber Wood
Scientific
Stichting Radboud University Medical Center
研究点 (2)
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