A study in healthy volunteers to improve methods for detection of GHB in drug rape victims

Conditions

Intoxication

Brief summary

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.

Detailed description

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.

Related papers

No related papers found yet.

Interventions

DRUGNatriumoxybat "Reig Jofre"

DRUGoral opløsning

DRUGSODIUM CHLORIDE

DRUGPARACETAMOL

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
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.	—

Secondary

Measure	Time frame
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.	—

Measure

Time frame

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.

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Countries

Denmark

Outcome results

None listed