Ongoing, recruitingTherapeutic exploratory (Phase II)Interventional

Explorative, randomized, double-blind, placebo-controlled, 3-way cross-over study to assess the effects of oral cannabidiol 30 and 700 mg in healthy male subjects on CNS and cortical excitability using the NeuroCart test battery and TMS.

This study is exploring how a cannabis-based oil, called cannabidiol (CBD), affects the brain and body. Healthy men will take either CBD oil at two different strengths (30mg or 700mg) or a dummy oil (placebo). The researchers will then carefully measure various functions, such as eye movements, memory, balance, and how the brain's nerves react, using a special set of tests and brain scans called TMS. They are trying to understand the effects of CBD on the central nervous system and how brain cells respond. It's a Phase II study, meaning it's an early-stage investigation to see if there are any interesting effects worth studying further.

At a glance

Status

Ongoing, recruiting

Phase

Therapeutic exploratory (Phase II)

Sponsor

Centre for Human Drug Research

Enrolment target

Start

17 Nov 2023

Neurological assessments

What is this study about?

This study is a research project looking at how cannabidiol (often called CBD oil) affects healthy men. CBD is a substance found in the cannabis plant, but it doesn't cause the 'high' associated with cannabis. Researchers want to understand if taking CBD oil changes how the brain and body work.

The men taking part will receive either one of two different doses of CBD oil (a low dose of 30mg or a higher dose of 700mg) or an inactive oil, called a placebo. A placebo looks exactly like the real CBD oil but has no active ingredient. This helps researchers compare the effects accurately. Participants won't know if they are receiving CBD or the placebo, and neither will the study team until the trial is over – this is called 'double-blind'. Each participant will try all three options (both CBD doses and the placebo) at different times, which is known as a 'cross-over' study design.

The study will use a range of tests to see what, if anything, changes after taking CBD. These tests include looking at how your eyes move, your memory skills, your balance, and how quick your brain processes information. They will also use a special technique called Transcranial Magnetic Stimulation (TMS), which uses magnetic pulses to safely stimulate and measure brain activity. This helps them understand how brain cells react to CBD. By carefully measuring these things, researchers hope to learn more about how CBD might affect the brain.

Key takeaways

This study investigates how CBD oil affects the brain and body.
It involves healthy men taking different doses of CBD or a dummy oil.
Tests include eye movements, memory, balance, and brain activity.
It's an early-stage study to gather initial information about CBD's effects.
You won't know if you're taking CBD or placebo, and neither will the doctors.

Who may be eligible?

To be able to take part in this study, participants must be adult men, aged 18 years or older. There is no upper age limit, meaning men of any age beyond 18 could potentially join.

This study specifically focuses on healthy men, so you would need to be generally well and not have any serious ongoing health conditions that might interfere with the study or the results. The researchers are looking for a specific group of people to ensure the study is safe and that the 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 male?
Are you 18 years old or older?
Are you generally healthy?
Are you able to attend clinic visits and complete the required tests?

Answer every question to see your result.

What does participation involve?

If you join this study, you'll visit the clinic on a few separate occasions. During each visit, you'll be given either one of the CBD oil doses or a dummy oil (placebo) to take. You won't know which one you're getting, and neither will the study staff until the study is finished, to keep the results fair. After taking the oil, you'll undergo a series of tests. These tests include eye movement tracking, memory tasks, balance checks, and assessments of how your brain responds using a special magnetic stimulation technique (TMS).

Throughout the study, the team will also check your vital signs like pulse and blood pressure, and keep track of any medications you might be taking. They'll also monitor you for any side effects. The study involves a few visits over a period, allowing you to try each of the three different options (two CBD doses and the placebo) in a randomised order, with breaks in between. The total duration of your involvement isn't specified but will involve these multiple visits and follow-ups.

Potential risks and benefits

Participating in research studies like this can help advance medical knowledge. While there's no direct personal health benefit for you from taking part, the information gathered could help others in the future by increasing our understanding of CBD. Potential risks might include mild side effects from the CBD oil, such as tiredness or stomach upset, though these are usually temporary. The tests, like TMS, are generally safe but may involve some minor discomfort. 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
Netherlands

Common questions

What is CBD oil?

CBD oil is a product made from a cannabis plant compound called cannabidiol. It's different from the part of cannabis that causes a 'high'.

Will I feel 'high' if I take the CBD oil?

No, CBD oil in this study is not expected to cause a 'high'. The study uses a form of CBD that does not have these intoxicating effects.

What is the 'NeuroCart test battery and TMS'?

These are special sets of tests specifically designed to measure how your brain and nervous system are working, including things like eye movements, memory, and brain cell activity using magnetic pulses.

Why are only men included in this study?

Sometimes early-stage studies focus on a specific group to help understand basic effects before expanding to a wider population. This allows researchers to reduce variability in the results.

What is a 'placebo'?

A placebo is a dummy treatment. It looks and tastes like the real CBD oil but contains no active ingredient. It helps researchers accurately compare the effects of the actual CBD.