Ongoing, recruitingPhase III and phase IV (Integrated)Interventional

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

This study is designed to find improved methods for detecting the drug GHB (often called the 'date rape drug') in healthy volunteers. The main goal is to figure out how long new indicators, or 'biomarkers,' in the blood stay different after someone takes GHB compared to not taking it. Researchers are also looking at how long these clues can be found in urine, hair, sweat, and even teeth. By understanding these timelines better, the study aims to develop more effective ways to detect GHB, which could be crucial in helping victims of drug-facilitated assault and assisting police investigations. They are also checking how the drug affects memory and physical appearance shortly after it's taken.

At a glance

Status

Ongoing, recruiting

Phase

Phase III and phase IV (Integrated)

Sponsor

Aarhus University

Enrolment target

Start

12 Sep 2022

Intoxication

What is this study about?

This study is really important because it's looking for better ways to find the drug GHB in people's bodies. GHB can be used to make someone intoxicated and vulnerable, often without their knowledge, so improving how we detect it is vital. The researchers are giving small, safe doses of GHB (or a harmless dummy pill, called a placebo) to healthy volunteers to see how their bodies react.

The main aim is to discover new 'biomarkers' – these are like unique chemical signals in your body that show when GHB has been taken. The study wants to find out how long these signals stay noticeable in blood, urine, and even hair or sweat. Knowing this timeline means doctors and police could have a bigger window of opportunity to detect GHB, which is often difficult because the drug leaves the body quickly.

Ultimately, the information from this study could make a real difference in helping victims of drug-related crimes. By finding more reliable and longer-lasting ways to detect GHB, investigators could gather stronger evidence, and victims could get the support and justice they deserve. It's all about improving our ability to identify when this drug has been used.

Key takeaways

The study aims to improve detection of the drug GHB.
It's looking for new 'biomarkers' in blood, urine, hair, and other samples.
The goal is to find out how long these biomarkers stay detectable.
Results could help victims of drug-related crimes and police investigations.
Healthy adults aged 18 and over are eligible to participate.

Who may be eligible?

To take part in this study, you need to be a healthy adult aged 18 or older. Both men and women are welcome to participate. The study is specifically looking for volunteers who are in good general health, as this helps researchers understand the basic effects of the drug without other health issues getting in the way.

While the detailed eligibility criteria aren't fully listed here, typically, you wouldn't be able to join if you have certain existing health conditions, are taking particular medications that might interfere with the study drugs, or if you are pregnant or breastfeeding. These checks are put in place to ensure your safety and that the study results are clear and accurate.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you 18 years old or older?
Are you generally in good health?
Are you able to attend several study visits?
Are you comfortable providing blood, urine, and other samples?
Do you understand that you might receive the study drug or a placebo?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you'll be given either a small, measured amount of the study drug (Natriumoxybat, which is a form of GHB) or a harmless dummy pill (placebo). You might also be given paracetamol (a common painkiller) or a salt water solution as part of the study. You will likely have several visits to the study clinic, where doctors and nurses will monitor your health closely. This will involve giving blood, urine, and possibly hair or oral fluid samples at different times over a period of weeks. You might also be asked to do some simple memory tests or have your physical appearance checked after taking the study medication. The study will continue for a certain period, and you'll have follow-up appointments to track any changes. The total length of your participation, including all visits and follow-ups, will be fully explained to you before you agree to join.

Potential risks and benefits

Potential benefits of taking part include contributing to important research that could significantly improve the detection of GHB, ultimately helping potential victims of drug-facilitated crime. You'll receive careful medical monitoring throughout the study. However, like all medications, the study drug might have side effects, and procedures like blood tests carry small risks, such as bruising or discomfort. All specific potential risks will be fully explained before you agree to participate. Remember, you can choose to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

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Unverified
Denmark

Common questions

What is GHB?

GHB is a powerful drug that can make someone feel drowsy, confused, or even unconscious. It's sometimes sadly used to spike drinks.

Why are researchers looking for new detection methods?

GHB leaves the body quite quickly, making it hard to detect in victims. New methods aim to find clues that last longer, helping with investigations and support.

Will I be given the actual drug GHB?

Yes, some volunteers will receive a carefully controlled, small amount of the study drug (a type of GHB) under strict medical supervision, or a harmless dummy pill (placebo).

What kind of samples will be collected?

Researchers will collect samples like blood, urine, oral fluid (from your mouth), and possibly hair or even sweat to look for these new detection clues.

Is this study safe for healthy people?

The study is designed with your safety as a top priority. You'll be closely monitored by medical staff, and all procedures are carefully planned.