A Double-blind, Randomized, Placebo-controlled, 4-arm Parallel-group, Multiple-Dose Study to Assess Efficacy and Safety of Medical Cannabis Aerosol via the Fixed-dose Syqe Inhaler as an Add-on Treatment of Diabetic Peripheral Neuropathic Pain
Diabetic nerve pain can cause burning, tingling, or shooting pains in the feet and hands that are difficult to treat. This clinical study is testing a medical cannabis inhaler to see if it can safely reduce this pain when added to a person's usual treatments. The inhaler delivers exact, measured doses of cannabis vapour directly to the lungs. Participants will be placed into groups by chance. Some will receive the real cannabis treatment, while others will receive a dummy inhaler that feels the same but contains no active medicine. Neither the participants nor the research team will know who receives which inhaler during the 16-week test. Doctors will track whether the treatment eases pain, improves sleep, and boosts daily quality of life, while carefully checking for any unwanted side effects.
At a glance
What is this study about?
Diabetes can sometimes injure the nerves, most often in the feet, legs, and hands. This condition is called diabetic peripheral neuropathy. It can trigger unpleasant sensations such as burning, stabbing pain, tingling, or extreme sensitivity to touch. For many people, existing painkillers do not work well enough or cause bothersome side effects. Finding safe, new ways to manage this constant pain is an important goal for doctors and researchers.
This trial is looking at medical cannabis as an add-on treatment for people who still have nerve pain despite taking their normal diabetes care. Cannabis contains natural compounds that may help calm overactive pain signals in the nervous system. In this study, the medicine is taken using a precision medical device called the Syqe Inhaler. This device turns the medicine into an aerosol mist, allowing the lungs to absorb a very precise, consistent dose every time.
Researchers want to find out whether using this inhaler over 16 weeks lowers everyday pain scores compared to a dummy device that has no active medicine. They will also look closely at whether the treatment helps people sleep better, reduces the need for extra emergency pain medicines, and improves overall wellbeing. Gathering this evidence helps doctors understand whether medical cannabis can be a safe and useful treatment choice in the future.
Key takeaways
- Tests a medical cannabis inhaler for diabetic nerve pain.
- Compares the active treatment against a dummy inhaler over 16 weeks.
- Open to adults aged 18 and over with nerve pain caused by diabetes.
- Aims to reduce pain, improve sleep quality, and check overall safety.
- Taking part is voluntary, and you can stop at any time.
Who may be eligible?
This trial is open to adults aged 18 and older who have been diagnosed with nerve pain linked to diabetes. Both men and women can join. Because the study focuses on people who still struggle with ongoing discomfort, it is aimed at those whose nerve pain has not fully settled with standard treatments.
While the trial welcomes adults of all ages, volunteers will need to undergo medical checks to ensure it is safe for them to take part. This usually means having stable diabetes and being able to safely use an inhaler.
People with certain health issues, such as severe heart or lung conditions, or those who have had problems with substance misuse, may not be able to join. The study team will review each person's full medical history and current list of medicines before confirming whether they can take part.
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 aged 18 or over.
- I have been diagnosed with diabetes.
- I experience ongoing nerve pain, such as burning or tingling in my feet or hands.
- My current pain medicines do not give me enough relief.
- I am able and willing to use a breath-operated inhaler every day.
What does participation involve?
Taking part in this study lasts for at least 16 weeks. At the start, the research team will explain the trial in detail and ask you to sign a consent form. You will have health checks, including blood and urine tests, heart traces (an ECG), and breathing tests, to make sure the trial is safe for you.
You will be assigned by chance to receive either the active cannabis medicine or a dummy inhaler. You will be shown how to use the handheld inhaler and will take your prescribed doses at home. You will also be asked to keep track of your daily pain levels, sleep quality, and any extra painkillers you take.
Throughout the study, you will attend regular clinic visits so doctors can monitor your health, check for side effects, and see how well your pain is controlled. At some visits, small blood samples may be taken to measure the levels of the medicine in your body.
Potential risks and benefits
Locations (3)
- —UnverifiedPoland
- —UnverifiedCzechia
- —UnverifiedGermany
Common questions
Will I definitely receive the medical cannabis?
No. This is a randomised trial, meaning a computer randomly decides whether you receive the active cannabis treatment or a dummy inhaler with no medicine.
Will using the inhaler make me feel high?
The inhaler delivers small, precisely controlled doses designed to relieve pain rather than create an intoxicating effect. However, some people might experience mild light-headedness or drowsiness.
Can I keep taking my current diabetes and pain medicines?
In most cases, this treatment is added to your existing care. The study doctor will check all your regular medicines to make sure they are safe to use together.
Is taking part in this clinical trial free?
Yes. All study-related medicines, tests, and medical visits are provided at no cost to you, and travel expenses are often reimbursed.
Can I leave the study if I change my mind?
Yes. You have the right to withdraw from the trial at any point, for any reason, without giving an explanation and without harming your ongoing healthcare.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
Interested in taking part?
Discussion
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