Active not recruitingPHASE1INTERVENTIONAL

The Pharmacokinetics of Single Dose Oral Tetrahydrocannabinol and Cannabidiol

This study investigates how the body processes tetrahydrocannabinol (THC) and cannabidiol (CBD), two main ingredients from cannabis, after a single oral dose. We want to understand how these substances behave in healthy adults compared to those with different stages of chronic kidney disease, including patients receiving regular kidney dialysis. The aim is to see if kidney problems change how the body absorbs, breaks down, and gets rid of these cannabis components. This information is important for the safe use of cannabis-based medicines, especially for people with kidney conditions. We are particularly interested in how these compounds are removed from the body during dialysis.

At a glance

Status

Active not recruiting

Phase

PHASE1

Sponsor

McMaster University

Enrolment target

Start

11 Jan 2024

Estimated completion

01 Mar 2025

Cannabis Chronic Kidney Diseases Dialysis

What is this study about?

This research study is about understanding how two important parts of cannabis, called THC and CBD, move through and are used by the body. THC is known for its psychoactive effects (what makes you feel 'high'), and CBD is being studied for various health benefits without the 'high'. Both are found in cannabis plants. We want to see how a single dose of a mixture of THC and CBD, given as a liquid by mouth, acts in different people.

Specifically, we are comparing how healthy adults process these substances versus adults who have kidney disease. Kidney disease can affect how the body cleans out medicines and other substances, so it's really important to know if it changes how THC and CBD are handled. We'll be looking at people with different levels of kidney disease, including those who are regular patients on dialysis.

The main goal is to learn how quickly THC and CBD are absorbed, how long they stay in the bloodstream, and how the body gets rid of them. For people on dialysis, we'll also be checking if dialysis treatment helps remove these substances from the body. This study is an important first step (Phase 1) to gather basic safety information and understand how the body deals with these cannabis components, which could help guide future medical uses.

Key takeaways

This study explores how the body handles THC and CBD, major cannabis compounds.
It aims to understand differences in healthy individuals and those with kidney disease, including dialysis patients.
Participants will take a single dose of THC/CBD liquid.
Blood, urine, and dialysis fluid samples will be collected to track the compounds.
The research helps ensure future safe use of cannabis-based medicines for people with kidney issues.

Who may be eligible?

You might be able to take part if you are over 25 years old. We are looking for healthy adults, as well as those with different stages of kidney disease, including if you are receiving regular kidney dialysis (at least twice a week for three hours or more, using a special tube called a tunneled catheter, and have been on dialysis for more than 90 days). You need to be willing to follow all study instructions and give your informed consent, which means you understand what the study involves and agree to participate.

There are certain reasons why you might not be able to join. For example, if your body mass index (a measure of your weight compared to your height) is too low (below 20) or too high (above 35). We also cannot include you if you depend on any drugs other than caffeine or nicotine, or if you have a history of serious bad reactions to cannabis or a mental health condition like psychosis. If you've used any cannabis products in the last month, or are taking medications that could react badly with THC or CBD (like certain epilepsy drugs or anti-fungal medicines), you won't be able to participate. We also can't include you if you have signs of liver problems, are pregnant or breastfeeding, have had recent changes in your weight, or have had very low blood pressure during dialysis recently.

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 over 25 years old?
Do you have a healthy kidney function, kidney disease, or are you on regular dialysis?
Are you able to take the study medication as instructed?
Have you used any cannabis products (natural or synthetic) in the last 30 days?
Do you have any serious mental health conditions like psychosis or mania?
Are you currently taking medications that could interact with cannabis compounds (e.g., certain epilepsy or anti-fungal drugs)?

Answer every question to see your result.

What does participation involve?

If you join this study, you will take a single dose of the study medication (a liquid containing THC and CBD) by mouth. You'll have blood samples taken several times over a few hours after taking the medication, and then again at 24 and 48 hours. If you don't have kidney failure requiring dialysis, we'll also ask you to collect all your urine for 24 hours. If you are on dialysis, apart from the blood samples, we will also collect samples of the fluid used during your dialysis session. For all participants, the total medical check-ups and sample collections will occur over a few days for the single dose. The study itself won't replace your regular medical care.

Potential risks and benefits

Taking part in this study may help us understand more about how cannabis components work in the body, especially for people with kidney conditions, which could benefit others in the future. There's no direct medical benefit to you personally. Possible risks include side effects from the study medication, which may be similar to those of cannabis, such as feeling drowsy, dizzy, or changes in mood or thinking. There are also minor risks with blood draws, like bruising or discomfort. You are free to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (1)

St. Joseph's Healthcare Hamilton
Verified postcode
Hamilton, Canada

Common questions

What are THC and CBD?

THC (tetrahydrocannabinol) and CBD (cannabidiol) are two main natural compounds found in the cannabis plant. THC is responsible for the 'high' feeling, while CBD does not typically cause this effect.

Why is this study important for people with kidney disease?

It's important because kidney disease can change how the body processes medicines. Understanding how THC and CBD are handled in people with kidney problems can help ensure these substances are used safely in the future.

Will I feel 'high' during the study?

The study involves THC, which can cause a 'high'. The researchers will monitor you closely for any effects, but you should expect some feeling changes.

How long will I need to be involved?

You will take the medication once, and then have blood and other samples collected over a few days, mainly within the first 48 hours for each participant.

Can I eat or drink normally during the study?

You will receive specific instructions about eating and drinking before and after taking the study medication to ensure accurate results. You will be told if any fasting is required.