EndoCannEd Study
Do you experience endometriosis-related pain and associated symptoms? Do you live in Victoria?
NICM Health Research Institute’s Associate Professor Mike Armour and PhD candidate Justin Sinclair are collaborating as investigators with Deakin University on the EndoCannED clinical trial.
The research team 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 emergency department, help with pelvic pain severity, fatigue, and improve quality of life.
Endometriosis a chronic inflammatory condition characterised by the presence of endometrial-like tissue outside of the uterus in the form of lesions. Many people with endometriosis find it difficult to achieve good pain and symptom control. Due to poor pain control, people with endometriosis often present to the emergency department (ED) with breakthrough pain.
The research team will be testing CBD oil alone compared to CBD Oil plus the use of vapourised medicinal cannabis flower that contains a moderate amount of THC (14%) that can be used when they have breakthrough pain of 6/10 or more. The third group will receive a placebo oil that looks and tastes the same as CBD oil but doesn’t have any active components.
All information will be captured online and all product will be provided free of charge along with a TGA approved vapouriser depending on group allocation. Apart from required blood tests for safety, all other information is captured remotely and no on-site visits will be required.
Who can join?
- People aged 20 years and over, who:
- Are currently living in Victoria, Australia;
- Have a confirmed diagnosis of endometriosis via one of the following laparoscopy, MRI or Ultrasound imaging by a medical doctor with input from a specialist with specific endometriosis expertise;
- Have not used any form of cannabis (including CBD products) in the previous three-months;
- Are not pregnant, breastfeeding or planning to become pregnant in the next three-months;
- Agree to not drive or operate heavy machinery if they are in the group which use a vapouriser to inhale medicinal cannabis flower;
- Possess a smartphone with internet connectivity
What's involved?
- After an initial assessment and consent, you will:
- Have blood taken to assess your liver and kidney function.
- Complete a series of questionnaires online 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.
- Participants will be randomly allocated into one of the two treatment groups (CBD oil alone or CBD oil + vapourised THC), or a placebo group. Over the three-month study, participants will be asked to:
- Follow the instructions for the investigational products as directed on the label and by research staff.
- Complete a regular short questionnaire by following an emailed link.
- 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.
What are the benefits for participating?
Participation in this study may help you to manage symptoms of endometriosis. However, please be aware that since there are no previous similar studies of medicinal cannabis in endometriosis, there may be no direct benefit to you from participating in this study. While the intervention we are testing was found useful in other patient populations, there is no guarantee it will be effective in people with endometriosis. However, this project may benefit the wider endometriosis community. It is likely to provide necessary data to design better treatments for people with endometriosis.
Interested in participating?
For more details about this study please read the following information before deciding on whether to participate.
In order to confirm your eligibility and register your interest, please complete the online form below.
If you have further questions, please contact:
Justin Sinclair
NICM Health Research Institute, Study Investigator - PhD Candidate
e. endocanned@westernsydney.edu.au
Human Research Ethics Committee Approval: This clinical trial has been approved by Deakin University Human Research Ethics Committee (Approval Number: 2022-342).
This study is supported by a Victorian Medical Research Acceleration Fund (VMRAF) grant.
NICM Health Research Institute Chief Investigator: Associate Professor Mike Armour.
