2022-501329-18-00招募中4 期
A study in healthy volunteers to improve methods for detection of GHB in drug rape victims
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- The primary end point of the trial is the time until the longest detectable biomarker in blood is no longer up- or downregulated in the active treatment group compared to the placebo group.
研究概览
简要总结
The primary objective is to investigate whether one or more of the identified potential biomarkers can be detected longer than GHB itself in blood.
研究设计
- 分配方式
- Randomized
- 主要目的
- Entire study
- 盲法
- Double (Monitor, Subject, Investigator, Analyst)
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
- •Healthy volunteers aged 18-65 years
- •Informed, written consent
- •Able to understand Danish
排除标准
- •Current or previous substance abuse or alcohol abuse
- •A psychiatric disorder that requires medical treatment, incl. major depression
- •Pregnant and breastfeeding women (Fertile women (defined as amenorrhea for less than 12 months) must have a negative HCG pregnancy test prior to intake of the trial medication)
- •Current or previous treatment with GHB
- •Treatment with valproate or topiramate
- •Treatment with benzodiazepines, opioids, or another CNS-depressant medicinal product
- •Hypersensitive to sodium oxybate or any of the excipients of Sodium Oxybate (i.e. malic acid and sodium hydroxide)
- •Succinic semialdehyde dehydrogenase deficiency
- •History of impaired hepatic or renal function
- •A diagnosis of epilepsy
- •A diagnosis of porphyria
结局指标
主要结局
The primary end point of the trial is the time until the longest detectable biomarker in blood is no longer up- or downregulated in the active treatment group compared to the placebo group.
The primary end point of the trial is the time until the longest detectable biomarker in blood is no longer up- or downregulated in the active treatment group compared to the placebo group.
次要结局
- Time until the longest detectable biomarker in urine, oral fluid, or hair is no longer up- or downregulated in the active treatment group compared to the placebo group.
- Fold change in biomarkers identified in a previous study as listed in table 1 in a previous study of Wang, T. et al. (Retrospective Metabolomics Analysis of Gamma-Hydroxybutyrate in Humans: New Potential Markers and Changes in Metabolism Related to GHB Consumption)
- Fold change in metabolites in blood, urine, and oral fluid in all samples collected over time as analysed by metabolomics.
- Concentration of GHB and identified biomarkers in dental calculus at one, two, and four weeks.
- Concentration of GHB in absorbed sweat 1 day after intake of study medication.
- Verbal Paired Associates (VPA) score 1.5 hours after intake for GHB.
- Effect of drug on physical appearance 1.5 hours after intake (yes/no).
- Concentration of GHB and possible biomarkers detected by routine screening.
研究者
Charlotte Uggerhøj Andersen
Scientific
Aarhus University
研究点 (1)
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