Medicinal cannabis for diabetic peripheral neuropathy

Medicinal cannabis for diabetic peripheral neuropathy study

Have you been diagnosed with diabetic peripheral neuropathy? If you are aged 18-75 and are currently on a stable regimen (for at least 30 days prior to screening) of duloxetine, gabapentin or pregabalin, either as monotherapy or in combination OR have used these medications in the past and discontinued their use at least 3 months ago, then you may be eligible to participate in a study on medicinal cannabis for diabetic peripheral neuropathy.

NICM Health Research Institute’s Dr Orit Holtzman is leading a clinical study on the effectiveness and safety of medicinal cannabis for adults with diabetic peripheral neuropathy (DPNP). The treatment period is 15 weeks. If you are eligible to enroll in this study, you will be randomly assigned to receive 1 of 3 dose levels of the study drug or the placebo administered via the study drug inhaler device. Your study group assignment is blinded, meaning you and your study doctor will not know whether you are receiving placebo or the dose level of study drug. The study team will provide instructions on how to use the study drug inhaler device.

During the study, you will use the study drug inhaler device 3 times a day and continue to take your prescribed medication(s) for DPNP. You will also be given rescue pain relief medication to take as needed for symptoms of DPNP.

Laboratory tests, physical examinations, heart and lung function tests, DPNP assessments and daily diaries, questionnaires and other procedures will be conducted as part of this study.

Who can join?

• 18 to 75 years of age
• Diagnosed with DPNP at least 3 months ago
• Currently on a stable regimen (for at least 30 days prior to screening) of duloxetine, gabapentin or pregabalin, either as monotherapy or in combination OR have used these medications in the past and discontinued their use at least 3 months ago

This is not a complete list of study requirements. The study doctor will review the full requirements for this study with you.

What’s involved?

• After an initial assessment and consent, you will:

• Be provided with an electronic device to complete an eDiary and some study questionnaires over a period of 7 days. Your average pain intensity will be calculated.

• Be randomly assigned to received 1 of the following treatments and receive the Syqe fixed-dose inhaler:

  • Aerosol containing 0.25 milligram (mg) of THC three times per day
  • Aerosol containing 0.50 milligram (mg) of THC three times per day
  • Aerosol containing 1.0 milligram (mg) of THC three times per day
  • Placebo containing 0 milligram (mg) of THC three times per day

• Attend on-site visits with the study doctor at NICM Health Research Institute (NICM HRI) to monitor symptoms and other safety parameters. At some visits, you will be asked to not to take your study treatment before coming to the site, so that assessments can be done before and after you take your study treatment. The on-site visits will involve:

  • Full physical examination: includes checking your general appearance, ears, eyes, nose, throat, heart, lungs, abdomen (stomach), back, lymph nodes, arms and legs, skin, neck (including thyroid), vascular, neurological system and any other notable physical conditions.

  • Vital signs: includes heart rate, blood pressure, respiration rate, weight, height (only at screening) and body temperature

  • Electrocardiogram (ECG): sticky patches will be placed on your chest that will be connected by wires to a machine that will record the electrical activity of your heart

  • Spirometry: a group of tests to check how well the lungs work. You will be blowing into a tube connected to a machine reading your lung function. It might take up to 8 trials within a single session.

  • Laboratory tests:

    Blood and urine samples will be collected

    1. A urine sample will be collected for safety tests to check your health and to check for the following drugs: cocaine, amphetamines, barbiturates, cannabinoids (including THC), opiates, phencyclidine (PCP) and methadone
    2. A pregnancy test will be done by women of childbearing age.
    3. 212 mL of blood will be taken from a vein in the arm that will be taken over a time period of 22 weeks. Your blood sample will be used for assessment of your long-term blood sugar level, how the body processes the study drug and checking for hepatitis B, C and HIV.

• You will answer several questionnaires, either by reading or completing questions yourself or through questions that your study staff asks you and documents your answers. These many include question about pain and how it impacts your life, sleep, mood and self-harm thoughts.

• You will be provided with detailed training on how to use the study treatment. The device will record the time and quality of the inhalations you will be taking.

What are the benefits for participating?

Participation in this study may help you to manage symptoms associated diabetic peripheral neuropathy. However, as there is little research in this area, it is also possible that you may not receive any benefits from medicinal cannabis.

There are no additional costs associated with participating in this research project, nor will you be paid. All medication, tests and medical care required as part of the research project will be provided to you free of charge.

You will be reimbursed for any reasonable travel, parking, meals and other expenses associated with the research project, upon production of a receipt.

Interested in participating?

For more details about this study please read the following information before deciding on whether to participate.

• View PIS here.

To confirm your eligibility and register your interest, please complete the online form below.

• View online screening form here.

If you have further questions, please contact the research team on dpnpstudy@westernsydney.edu.au

Human Research Ethics Committee Approval: This clinical trial has been approved by Bellberry Human Research Ethics committee (2024-04-426-AA)

This study is sponsored in Austalia by by Syneos Health Australia Pty Ltd.

NICM Health Research Institute Principal Investigator: Dr Orit Holtzman, Tel: 0402541526, Email: dpnpstudy@westernsydney.edu.au

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