Ongoing, recruitingTherapeutic exploratory (Phase II)Interventional

CBD, amitriptyline and tramadol drug-drug interaction study

This study is investigating how a medicine known as CBD interacts with two common pain relief drugs, amitriptyline and tramadol. Doctors are keen to understand if using these medications together changes how effective they are or if it leads to any new or different side effects, particularly for individuals experiencing nerve-related problems. This is an early-stage study (Phase II) that explores these interactions. By looking closely at how these drugs behave when taken together, researchers hope to gather important information that could help doctors prescribe them more safely and effectively in the future, providing better care for patients. They are looking for adults of any age to participate.

At a glance

Status

Ongoing, recruiting

Phase

Therapeutic exploratory (Phase II)

Sponsor

Centre for Human Drug Research

Enrolment target

Start

14 Dec 2023

Neurological assessments

What is this study about?

You might have heard about CBD (often pronounced C-B-D), which is a compound found in cannabis plants. It's being looked at for various health conditions, including pain. Amitriptyline and tramadol are two medicines that doctors often prescribe for different kinds of pain, including pain related to nerves.

This study is trying to understand what happens when CBD is taken at the same time as amitriptyline or tramadol. Sometimes, when you take two different medicines together, they can affect how each other works. One medicine might make the other stronger, weaker, or even cause different side effects. This is called a 'drug-drug interaction'. For people with nerve-related health issues, understanding these interactions is really important so that treatments can be as safe and effective as possible.

This is an early-stage study. It's called 'Phase II', which means researchers are still exploring and gathering information about how these medications interact. They are not yet looking at whether the combination is better at treating a condition, but rather at the fundamental way the drugs behave together in the body. The results from this study will help doctors make better decisions about prescribing these medicines in combination in the future.

Key takeaways

The study explores how CBD interacts with common pain medications, amitriptyline and tramadol.
It aims to understand if combining them changes how they work or causes new side effects.
This is an early-stage study to gather fundamental information about drug interactions.
Adults aged 18 and over, of any gender, are potentially eligible to participate.
Participation involves taking study medications and undergoing neurological assessments.
You have the right to withdraw from the study at any time.

Who may be eligible?

This study is looking for adults aged 18 years and older. There's no upper age limit, meaning people of any adult age can potentially take part. Both men and women are welcome to participate in this research.

To be eligible, you would likely need to be in good general health, or have specific nerve-related conditions that the study is interested in exploring. The detailed rules for who can join are usually quite specific and would be discussed fully by the study team.

It's important to understand that if you are already taking certain medications, or if you have specific health conditions, you might not be able to participate. This is 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 comfortable potentially taking CBD, amitriptyline, or tramadol?
Are you available for regular clinic visits and tests?
Do you have a nerve-related condition, or are you generally healthy enough to participate?
Are you able to follow important study instructions carefully?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you would likely have several visits to a clinic or hospital. During these visits, you might have some neurological assessments, which are tests to check your nerve function and how your body is responding. You would be given the study medications (CBD, amitriptyline, or tramadol, or a combination) to take as instructed. Researchers would monitor you closely for any changes or side effects.

This would involve regular check-ups, possibly blood tests, and discussions about how you're feeling. The study team would explain the exact schedule and what's expected of you, including how long you'd need to take the medication and the total duration of your involvement in the study, which could range from several weeks to a few months.

Potential risks and benefits

Taking part in any study has potential benefits and risks. For you, a potential benefit might be contributing to important medical knowledge that could help future patients. You might also receive close medical attention during the study. However, there are also risks, such as experiencing side effects from the medications, including those that might arise from the medicines interacting. You might also undergo tests that have minor discomforts. It's very important to remember that you have the right to withdraw from the study at any time, for any reason, without it affecting your usual 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
Netherlands

Common questions

What is CBD?

CBD stands for cannabidiol. It's a compound found in cannabis plants that is being studied for its potential health benefits, but it does not make you 'high'.

What are amitriptyline and tramadol used for?

Both amitriptyline and tramadol are medicines commonly prescribed for different types of pain, including pain that involves nerves.

Why are they studying these medications together?

Researchers want to see if taking CBD with amitriptyline or tramadol changes how each medicine works in your body, or if new side effects appear, which is called a 'drug-drug interaction'.

Is this study checking if the combination works better?

No, this is an early-stage study (Phase II) mainly focused on understanding how these medications interact, rather than testing if the combination is more effective than taking them alone.

Who can take part in this study?

Adults aged 18 and over, of any gender, who meet specific health criteria, might be able to join. The study team will check if you are suitable.