Deakin researchers, together with NICM Health Research Institute, are seeking participants to be involved in a clinical trial examining the safety, tolerability and acceptability of two different medicinal cannabis interventions in people with endometriosis. The study will also explore if the tested interventions reduce the number of presentations to the emergency department, help with pelvic pain severity, fatigue, and improve quality of life.

Professor Antonina Mikocka-Walus from Deakin said insufficient pain control can lead to people with endometriosis presenting to emergency departments with breakthrough pain. “Despite substantial use of these medications, most people with endometriosis in Australia report poor pain and symptom control.” The project will involve 63 patients, living in Victoria, who will be monitored by researchers to learn whether the use of medicinal cannabis reduces the need for them to present to emergency departments.

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Who can participate?

You may be eligible to participate if:

  • You have endometriosis (confirmed either via laparoscopy, MRI or ultrasound),
  • Live in Victoria,
  • Are 20 years of age or older, and
  • Have presented at least twice to the emergency department for symptoms related to your endometriosis in the past six months.

Please note that you will not be able to drive a car for up to 4 months while participating in the study. 

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What does the research involve?

After an initial assessment and consent, participants will:

  • Have blood taken to assess your liver and kidney function.
  • Complete a series of questionnaires on a mobile phone app for one week to assess your current level of endometriosis-related pain.
  • Be randomly allocated into one of the two treatment groups (CBD oil alone or CBD oil + vapourised THC), or a placebo group.
  • Complete a two-week dosage phase to determine the best daily dose for your levels of pain.

Over the three-month active phase of the study, participants will be asked to:

  • Follow the instructions for the investigational products as directed on the label and by the research staff.
  • Complete a regular short questionnaire as prompted by the mobile phone app.

After treatment:

  • Have blood taken to monitor liver and kidney function.
  • Complete a short exit survey and exit focus group which will be able to be completed virtually.

How do I get involved?

If you would like to know more about the study, please click on the link below for more detail and a Plain Language Statement. If you have any questions please contact us at endocanned@deakin.edu.au

Click here