KF2025#1 trial: Ketamine, cannabidiol and cobicistat interaction study
This Phase 1 pharmacology trial is studying how the human body processes three specific medicines when they are used together: ketamine, cannabidiol (CBD), and cobicistat. Ketamine is used for pain and mental health, CBD is a compound found in cannabis used for various conditions, and cobicistat is a medicine that changes how the liver breaks down other drugs. Because more people are using ketamine and CBD for medical reasons, doctors need to know what happens if they are taken alongside other medicines. Healthy adult volunteers will take these medications under close medical supervision. The research team will collect blood samples to measure drug levels and check for any unexpected reactions. The study does not treat an illness, but the findings will help ensure future patients can take their medications safely without dangerous interactions.
At a glance
What is this study about?
When people take two or more medicines at the same time, the drugs can sometimes interfere with each other. The liver works like a processing factory, using natural proteins called enzymes to break down medicines and clear them from your body. If one drug slows down or speeds up this process, it can cause another drug to build up to unsafe levels or stop working properly. This trial looks specifically at how ketamine, cannabidiol (CBD), and a drug booster called cobicistat affect one another in the body.
Ketamine is commonly used in hospitals as an anaesthetic and pain medicine, and is increasingly prescribed for severe depression. CBD is widely used for health symptoms like pain and anxiety. Cobicistat is a medication commonly used in HIV treatment to boost the strength of other drugs by temporarily slowing down liver enzymes. By giving these substances to healthy volunteers in carefully controlled amounts, researchers can map out exactly how their levels rise and fall in the bloodstream.
This type of study is called a Phase 1 clinical pharmacology or bioequivalence study. Because it is an early-stage study, it takes place with healthy volunteers rather than people who are unwell. This ensures that any changes in drug levels are caused solely by the medicines interacting, rather than an underlying health condition.
The findings from this study will provide crucial safety guidance for doctors and pharmacists worldwide. As medical treatments evolve, knowing how these specific compounds interact will prevent harmful side effects and help doctors prescribe the right doses for patients in the future.
Key takeaways
- This is a Phase 1 study in healthy adults aged 18 and older.
- It tests how ketamine, CBD, and cobicistat interact with each other inside the body.
- There is no direct health benefit to participants, but the results help improve future patient safety.
- Taking part involves health checks, taking the study medications, and regular blood tests.
- Participation is completely voluntary and you can leave the study at any time.
Who may be eligible?
This study is looking for healthy adult volunteers aged 18 and older. Because the goal is to see how these medicines behave in a typical, healthy human body, participants should generally be in good overall health with no significant long-term illnesses.
You are unlikely to be eligible if you have serious heart, liver, or kidney problems, or a history of substance misuse or psychiatric conditions. Because ketamine and CBD affect the brain, and cobicistat affects liver enzymes, participants must usually avoid taking regular prescription drugs, over-the-counter medicines, or herbal remedies during the study.
Women who are pregnant, planning to become pregnant, or breastfeeding will not be able to take part. The trial team will carry out standard health checks, such as blood tests and heart tracings, to confirm whether it is safe for you to join.
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.
- I am an adult aged 18 or older.
- I am generally in good physical and mental health.
- I am not currently pregnant or breastfeeding.
- I am willing to attend clinic visits and provide blood samples.
- I am able to pause taking unnecessary supplements or non-essential medicines if advised by the research team.
What does participation involve?
Taking part in this study involves visiting a specialist clinical research unit. You will begin with a screening visit where doctors check your medical history, perform a physical examination, and take blood and urine samples to make sure you are fit to join. If eligible, you will attend one or more study sessions where you will receive the study medications under close supervision. This may require an overnight stay or full days at the clinic so the medical team can take repeated blood samples over several hours. These samples show exactly how fast the medicines enter and leave your body. You will also have routine health checks, such as blood pressure and heart monitoring. After the treatment visits are complete, there will be a final follow-up appointment to confirm you are feeling well. The entire study typically lasts between a few weeks and a few months from start to finish.
Potential risks and benefits
Locations (1)
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Common questions
Will taking ketamine make me feel strange?
Ketamine can cause temporary side effects such as feeling lightheaded, sleepy, or experiencing unusual sensations. These effects usually wear off quickly, and medical staff will be with you the entire time to make sure you are safe and comfortable.
Do I get paid for taking part?
Phase 1 trials involving healthy volunteers usually offer financial compensation for your time, travel expenses, and inconvenience. The study team can give you exact details about this during your initial contact.
Can I continue taking my regular vitamins or medications?
Usually, no. Because this study tests how the body breaks down medicines, other tablets, supplements, or herbal remedies can interfere with the results. You must discuss everything you take with the study team.
Will I have to stay overnight in the clinic?
Many drug interaction studies require one or more overnight stays so that staff can monitor you closely and collect blood samples at precise times. The research team will explain the exact schedule before you agree to take part.
What happens if I decide I want to stop?
You are completely free to withdraw from the study at any point. Deciding to leave will not affect your future NHS medical care in any way.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
Interested in taking part?
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