Ongoing, recruitingHuman Pharmacology (Phase I)- OtherInterventional

Tramadol Administered Orally to Healthy Subjects for the Improvement of its Detection in Biological Matrices in the Context of Anti-Doping Control

This study is investigating how the painkiller tramadol moves through and then leaves the human body. The main goal is to improve the ways scientists can detect tramadol in people's samples, like urine or blood. This research is important for anti-doping control in sports, ensuring that tests are accurate and fair. Healthy volunteers are needed for this early-stage study, where participants will take tramadol by mouth. The information gathered will help create better methods to identify tramadol, supporting efforts to prevent its misuse and maintain a level playing field in sports.

At a glance

Status

Ongoing, recruiting

Phase

Human Pharmacology (Phase I)- Other

Sponsor

Parc De Salut Mar

Enrolment target

Start

17 Apr 2023

healthy subjects

What is this study about?

This study is all about a medicine called tramadol, which is a painkiller. You might have heard of it being used to help with moderate to severe pain. The main purpose of this research is a bit like forensic science – it's trying to get really good at finding tramadol in people's bodies after they've taken it.

Imagine you're a detective, and you need to know exactly how a certain substance behaves in the body. That's what scientists are doing here. They want to understand how long tramadol stays in the body, which parts of your body it goes to, and how it eventually leaves. To do this, they need healthy volunteers to take a dose of tramadol.

This kind of detailed information is really important for sports. It helps anti-doping agencies develop better and more accurate tests. By improving these tests, they can more reliably detect if an athlete has used tramadol. This helps to keep sports fair and safe for everyone involved, making sure no one has an unfair advantage.

Key takeaways

Aims to improve detection of tramadol in biological samples.
Important for fair play and safety in sports (anti-doping).
Needs healthy adults (18+) as volunteers.
Involves taking tramadol and providing samples (e.g., blood/urine).
Early-stage research contributing to scientific understanding.

Who may be eligible?

This study is open to both men and women.

To join, you must be at least 18 years old. There is no upper age limit, meaning older adults are also welcome to participate.

As the study is looking at how tramadol affects a typical healthy person, they are specifically looking for volunteers who do not have any major health problems.

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 at least 18 years old?
Do you consider yourself a healthy person with no major medical conditions?
Are you comfortable taking a prescribed medicine (tramadol) as part of the study?
Are you able to visit a study clinic for tests and sample collection?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you will be considered a healthy volunteer. This means you will receive a dose of tramadol medicine by mouth. The study team will then take samples from you, such as blood or urine, at different times. This is so they can see how the tramadol moves through your body and when it leaves. You might need to visit a clinic or hospital for these assessments. The study duration is not specified, but this type of early-phase study usually involves a short period of active participation and follow-up to collect all necessary data.

Potential risks and benefits

A potential benefit of taking part is contributing to scientific knowledge that can help make sports fairer and improve drug detection methods. All medicines have potential side effects; tramadol can cause drowsiness, sickness, or dizziness. The research team will carefully monitor you for any effects. You are free 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
Spain

Common questions

What is tramadol?

Tramadol is a type of pain medicine, usually prescribed for moderate to severe pain. It's important to only take it when advised by a doctor.

Why is this study important for sports?

This study helps anti-doping agencies create better tests to find tramadol in athletes. This ensures fair competition and keeps sports safe for everyone.

Will I get paid to participate?

The information provided does not state whether participants will be paid. This is a good question to ask the study team if you're interested in joining.

Are there any risks to taking part?

Like any medicine, tramadol can have side effects such as feeling tired or sick. The research team will explain all known risks and monitor your health carefully.

How long will I need to be involved?

The study details don't specify the exact duration, but phase one studies like this generally involve a limited number of visits and follow-up tests over a short period.