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Study on Medical Cannabis Aerosol for Treating Diabetic Nerve Pain in Patients Using Syqe Inhaler

Fast replyInvestigationalNo placebo

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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 studying the effects of a new treatment for Diabetic Peripheral Neuropathic Pain, a type of pain that affects people with diabetes, often causing discomfort in the feet. The treatment being tested is a medical cannabis aerosol, which is a form of cannabis that is inhaled as a vapor using a special device called the Syqe Inhaler. This inhaler is designed to deliver precise doses of the cannabis flower, specifically from the plant Cannabis Sativa L. 'Afina'. The study will compare the effects of this treatment to a placebo, which is a substance that looks and feels like the treatment but does not contain any active cannabis components.

The purpose of the study is to evaluate how effective and safe the medical cannabis aerosol is when used as an additional treatment for managing pain in patients with diabetic peripheral neuropathic pain. Participants in the study will be randomly assigned to one of four groups, each receiving different doses of the cannabis aerosol or the placebo. The treatment will be administered three times a day over a period of 15 weeks. Throughout the study, participants will be monitored to assess changes in their pain levels and any side effects they may experience.

By participating in this study, researchers aim to gather valuable information on whether the medical cannabis aerosol can help reduce pain intensity in patients with diabetic peripheral neuropathic pain. The findings from this study could potentially lead to new treatment options for individuals suffering from this condition, improving their quality of life and pain management strategies.

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, the patient will be randomly assigned to one of four groups. This process is called randomization and ensures that each participant has an equal chance of receiving any of the treatments being tested.
Step 2
Treatment administration
The patient will receive either a medical cannabis aerosol or a placebo. The medical cannabis aerosol contains different doses of tetrahydrocannabinol (THC): 0.25 mg, 0.5 mg, or 1.0 mg. The placebo is designed to mimic the sensation of inhalation without containing any active cannabis components.
The treatment is administered using a device called the Syqe Inhaler. The patient will inhale the treatment three times a day.
Step 3
Duration of treatment
The treatment will continue for a period of 15 weeks. During this time, the patient will be required to adhere to the study protocol and avoid using any other cannabis products.
Step 4
Monitoring and assessments
Throughout the study, the patient's pain levels will be monitored using a numeric rating scale. This involves recording the average pain intensity over a 24-hour period each week.
Additional assessments will include the Neuropathic Pain Symptom Inventory and the Brief Pain Inventory for Diabetic Peripheral Neuropathy. These tools help evaluate changes in pain symptoms and their impact on daily life.
Step 5
Safety evaluations
Safety and tolerability will be assessed through various tests, including the Michigan Neuropathy Screening Instrument, spirometry, and electrocardiograms. Blood and urine tests will also be conducted to monitor the patient's health.
The study will track any adverse events, which are any unwanted effects experienced during the trial. The severity and frequency of these events will be recorded.
Step 6
Completion of the study
At the end of the 15-week period, the patient will complete the study. Final assessments will be conducted to evaluate the overall impact of the treatment on pain levels and quality of life.

Who can join the trial?

14 criteria

Must be able to understand and willing to sign the informed consent form, and agree to follow the study rules.
Body mass index (BMI) should be between 18 and 40 kg/m².
Must have recorded daily average pain intensity at least 5 out of 7 days before starting the study.
Agree not to drive or use heavy machinery during the study treatment period.
Female participants must have a negative pregnancy test before starting the study. If they cannot have children, they must meet certain criteria, such as being post-menopausal or having had certain surgeries.
Participants who can have children and are sexually active must use highly effective birth control methods. For females, this includes hormonal contraceptives or devices. For males, this includes vasectomy or abstinence.
Must be between 18 and 75 years old at the time of screening.
Agree to use only the medical cannabis provided by the study team and not use any other cannabis products during the study.
Agree not to join other clinical studies while participating in this study.
Must be treated with standard medications for diabetic peripheral neuropathic pain, such as duloxetine, gabapentin, or pregabalin, with a stable dose for at least 30 days before screening. Non-drug therapies like behavioral or cognitive therapy are allowed if they have been stable for 3 months before screening.
Must not be current users of cannabis products. Previous users must not have used cannabis within 3 months before screening, or they must have never used cannabis.
Must have a diagnosis of diabetic peripheral neuropathic pain, with foot pain for at least 6 months and a certain pain score as measured by a specific tool.
Must have a confirmed diagnosis of type I or type II diabetes with stable blood sugar levels controlled by diet, medication, or insulin for at least 3 months before screening.
Hemoglobin A1c, a measure of blood sugar levels, must be less than 9% at screening.

Who cannot join the trial?

10 criteria

Patients who are pregnant or breastfeeding cannot participate.
Individuals with a history of severe mental health disorders, such as schizophrenia, are excluded. Schizophrenia is a mental health condition that affects how a person thinks, feels, and behaves.
People with a known allergy to cannabis or any of its components are not allowed to join the study.
Participants who have used cannabis or cannabis products within the last 30 days before the study starts are excluded.
Individuals with a history of substance abuse, which means having problems with drugs or alcohol, cannot take part.
Patients with significant heart problems, such as uncontrolled high blood pressure or heart disease, are not eligible. Heart disease refers to conditions that affect the heart's ability to function properly.
People who are currently participating in another clinical trial are not allowed to join this study.
Individuals with severe liver or kidney disease are excluded. The liver and kidneys are important organs that help filter and clean the blood.
Patients who have had a major surgery within the last 3 months are not eligible.
Individuals with a history of epilepsy or seizures are excluded. Epilepsy is a condition that causes repeated seizures, which are sudden bursts of electrical activity in the brain.

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Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

Verified
Centrum Badan Klinicznych Pi-House Sp. z o.o.
Gdansk, Poland
Responsive
Centrum Zdrowia Dziecka I Rodziny Im. Jana Pawla II W Sosnowcu Sp. z o.o.
Sosnowiec, Poland
Verified
Clintrial s.r.o.
Prague, Czechia

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Investigated drugs

Medical Cannabis Aerosol is being studied as an additional treatment for diabetic peripheral neuropathic pain. It is administered using a fixed-dose inhaler, which allows patients to inhale the medication. The study aims to determine how effective this cannabis aerosol is in reducing pain intensity when used regularly.

Cannabis Sativa Flower

What is already known about the treatment

Medical Cannabis Aerosol – This medication is administered through inhalation using a fixed-dose inhaler, specifically designed to deliver a controlled amount of cannabis aerosol. It is currently being studied in clinical trials as an add-on treatment for diabetic peripheral neuropathic pain. The main therapeutic indication is to alleviate pain associated with this condition. At the molecular level, the active component, delta-9-tetrahydrocannabinol (THC), interacts with cannabinoid receptors in the nervous system, which may help modulate pain perception. It is classified pharmacologically as a cannabinoid.

Investigated diseases

Diabetic Peripheral Neuropathic Pain – This condition is a type of nerve damage that occurs in people with diabetes, affecting the peripheral nerves, which are the nerves outside the brain and spinal cord. It typically causes pain, tingling, or numbness in the hands and feet. The pain can be described as burning, stabbing, or shooting, and it often worsens at night. Over time, the symptoms may progress, leading to increased discomfort and potential difficulties with mobility. The condition is a result of prolonged high blood sugar levels, which can damage nerve fibers, particularly in the extremities. Managing blood sugar levels is crucial to slowing the progression of nerve damage.