Not recruiting

Study on the Effects of Cannabidiol on the Central Nervous System in Healthy Male Participants

Investigational

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on understanding the effects of a substance called cannabidiol on the central nervous system (CNS) in healthy male participants. Cannabidiol, often referred to as CBD, is a compound found in cannabis plants. The study will use a flavored oil form of CBD, known as Clinican CBD 10% oil flavored, and will compare its effects to a placebo. The main goal is to observe how different doses of CBD, specifically 30 mg and 700 mg, influence certain brain functions and excitability, which refers to how easily the brain responds to stimuli.

Participants will take part in a series of tests designed to measure various aspects of brain activity and function. These tests include the NeuroCart test battery and Transcranial Magnetic Stimulation (TMS), which are methods used to assess brain performance and excitability. The study will look at how CBD affects tasks related to eye movements, memory, and body balance, among others. The trial will also monitor any side effects and changes in vital signs, such as heart rate and blood pressure, throughout the study period.

The study is structured as a randomized, double-blind, placebo-controlled, 3-way cross-over trial. This means that participants will receive different treatments in a random order, and neither the participants nor the researchers will know which treatment is being administered at any given time. The trial aims to provide insights into how CBD might influence brain function and could potentially inform future research or treatments involving CBD.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Joining the study
Upon joining the study, you will be required to provide a signed informed consent. This is a document that confirms your understanding of the study and your willingness to participate.
You must be a healthy male between the ages of 18 and 55, with a body mass index (BMI) between 18 and 30 kg/m², and a minimum weight of 50 kg.
Effective contraception must be practiced during the study and for at least 90 days after the last dose of the study treatment.
Step 2
Initial assessment
An initial assessment will be conducted to ensure you meet all the criteria for participation. This may include a review of your medical history and a physical examination.
You will need to communicate effectively in the Dutch language and comply with study restrictions.
Step 3
Medication administration
You will receive a single oral dose of cannabidiol at either 30 mg or 700 mg, or a placebo. A placebo is a substance with no active medication, used to compare effects.
The medication is administered in the form of a solution in oil, taken orally.
Step 4
Testing and monitoring
You will undergo various tests to assess the effects of the medication on your central nervous system (CNS). These tests include measuring eye movements, memory tests, and body sway assessments.
Additional tests will measure changes in brain activity using techniques like transcranial magnetic stimulation (TMS).
Step 5
Follow-up visits
Throughout the study, you will have follow-up visits to monitor your health and any potential side effects.
Your vital signs, such as pulse rate and blood pressure, will be checked regularly.
Step 6
Completion of study
Once all assessments are completed, your participation in the study will conclude.
You will be informed about the results and any further steps if necessary.

Who can join the trial?

5 criteria

Signed informed consent before any study-related procedure. This means you agree to participate after understanding the study details.
Must be a healthy male between 18 and 55 years old.
Body mass index (BMI) should be between 18 and 30 kg/m², and you must weigh at least 50 kg. BMI is a measure of body fat based on height and weight.
Must use effective birth control during the study and for at least 90 days after the last dose of the study treatment.
Must be able to communicate well with the study doctor in Dutch and be willing to follow the study rules.

Who cannot join the trial?

2 criteria

Participants must be male.
Participants must not be part of a vulnerable population. This means they should not be in a group that might need special protection or care.

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Investigated drugs

Cannabidiol is a compound found in the cannabis plant. In this clinical trial, it is being tested to see how it affects the brain and nervous system. Researchers are interested in understanding how cannabidiol influences certain brain activities and responses. The study uses special tests to measure these effects, which can help determine if cannabidiol has potential benefits for brain health or function. Participants in the trial take cannabidiol orally, meaning they swallow it, and then undergo various tests to see how their brain activity changes.

Cannabidiol

What is already known about the treatment

Cannabidiol – Cannabidiol is administered orally in the form of a pill or liquid. It is currently being studied in clinical trials to understand its effects on the central nervous system, particularly in healthy male subjects. The main therapeutic indications being explored include its potential impact on neurological assessments and brain excitability. At the molecular level, cannabidiol interacts with the body's endocannabinoid system, which plays a role in regulating various physiological processes. It is classified pharmacologically as a cannabinoid, a type of compound found in cannabis plants.

Investigated diseases

Neurological assessments – Neurological assessments are evaluations of the nervous system to understand its function and detect any abnormalities. These assessments often involve a series of tests that measure various aspects of brain and nerve function, such as reflexes, motor skills, sensory perception, balance, and cognitive abilities. The progression of findings from these assessments can indicate changes in neurological function over time. They help in identifying issues like memory problems, coordination difficulties, or changes in mental status. The results can guide further investigation into specific neurological conditions. Regular assessments can track the progression of neurological health or disease.