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Study on Detecting Sodium Oxybate in Intoxication Cases Using Sodium Oxybate, Sodium Chloride, and Paracetamol in Healthy Volunteers

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying the detection of Gamma-Hydroxybutyrate (GHB), a substance sometimes involved in cases of intoxication, such as drug-facilitated crimes. The study aims to improve methods for detecting GHB in the body by identifying potential biomarkers, which are substances that can indicate the presence of GHB for a longer period than GHB itself. The trial involves healthy volunteers who will be given sodium oxybate, an oral solution that is chemically similar to GHB, to help researchers understand how long these biomarkers can be detected in the body.

Participants in the study will receive either the active treatment, which is sodium oxybate, or a placebo. The study will also involve the use of sodium chloride and paracetamol as part of the research process. Sodium chloride is a common salt solution, and paracetamol is a widely used pain reliever. The purpose of the study is to see how long the biomarkers can be detected in different body fluids and tissues, such as blood, urine, oral fluid, hair, and even dental calculus, which is the hardened plaque on teeth.

The study will monitor various aspects, including the concentration of GHB and the identified biomarkers in these samples over time. Additionally, the study will assess the effects of the drug on memory and physical appearance shortly after intake. This research is important for developing better ways to detect GHB in situations where it may have been used without a person's knowledge, helping to improve safety and justice in such cases.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Joining the study

    Upon joining the study, you will be required to provide informed, written consent. This means you agree to participate after understanding the study's purpose and procedures.

    You must be a healthy volunteer aged between 18 and 65 years and able to understand Danish.

  2. Step 2

    Medication administration

    You will receive an oral solution containing sodium oxybate, sodium chloride, and paracetamol. The specific dosage, frequency, and duration of administration will be explained to you by the study team.

  3. Step 3

    Monitoring and sample collection

    Throughout the study, your blood, urine, oral fluid, and hair samples will be collected to monitor the presence of biomarkers and GHB (gamma-hydroxybutyrate).

    The primary goal is to determine how long these biomarkers can be detected in your body compared to a placebo group.

  4. Step 4

    Additional assessments

    You will undergo various assessments, including measuring the concentration of GHB in dental calculus at one, two, and four weeks.

    The concentration of GHB in absorbed sweat will be checked one day after taking the study medication.

    A Verbal Paired Associates (VPA) score will be recorded 1.5 hours after taking GHB to assess memory function.

    The effect of the drug on physical appearance will be evaluated 1.5 hours after intake.

  5. Step 5

    Completion of the study

    The study is expected to end by August 31, 2025. Your participation will contribute to understanding the detection of GHB and its biomarkers in the body.

Who can join the trial?

5 criteria

  • Participants must be healthy volunteers.
  • Participants must be aged 18 to 65 years.
  • Participants must provide written consent after being informed about the study.
  • Participants must be able to understand Danish.
  • Both male and female participants are eligible.

Who cannot join the trial?

1 criterion

  • People who are currently experiencing intoxication cannot participate. Intoxication means being under the influence of substances like drugs or alcohol.
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Investigated drugs

GHB is a substance that is sometimes used illegally to make people feel relaxed or sleepy. In this study, researchers are looking at how long GHB can be detected in the blood after it has been taken. This is important because GHB is sometimes used in crimes, and being able to detect it in the blood for a longer time could help in investigations.

What is already known about the treatment

GHB – GHB, or gamma-hydroxybutyrate, is typically administered orally in liquid form. It is currently being studied in clinical trials to improve detection methods in cases of drug-facilitated crimes, such as drug rape. The main therapeutic use of GHB is for treating conditions like narcolepsy, but it is also known for its misuse in recreational settings. At the molecular level, GHB acts by binding to specific receptors in the brain, which can lead to sedation and euphoria. It is classified pharmacologically as a central nervous system depressant.

Investigated diseases

Intoxication – Intoxication refers to the condition that occurs when a person has consumed a toxic substance, leading to physical and mental impairment. The progression of intoxication depends on the substance involved, but it generally begins with mild symptoms such as dizziness, nausea, or euphoria. As the condition advances, more severe symptoms can develop, including confusion, impaired judgment, and loss of coordination. In some cases, intoxication can lead to unconsciousness or other serious effects on the body's systems. The duration and severity of symptoms can vary based on the amount and type of substance consumed. Recovery from intoxication typically involves the body metabolizing and eliminating the toxic substance.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase ITrial ID2022-501329-18-00Estimated enrolment30 patientsSponsorAarhus University

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