Medicinal cannabis for endometriosis: The EndoCann Trial
A placebo controlled, double blind, randomised controlled trial assessing the effect of medicinal cannabis on pelvic pain in adults with endometriosis: The Endocann trial
Western Sydney University
126 participants
Apr 11, 2024
Interventional
Conditions
Summary
Endometriosis is an oestrogen-dependent, chronic inflammatory condition characterised by the presence of endometrial-like tissue outside of the uterus in the form of lesions, affecting around 1 in 7 women and those assigned female at birth in Australia. Endometriosis has a significant impact on one's physical, psychological, and social wellbeing. Unfortunately many of the pharmaceutical medications for endometriosis have bothersome side effects or should only be used for a short period of time due to concerns related to dependence and addiction. Medicinal cannabis has well described analgesic, anti-inflammatory, anxiolytic, anti-depressant, and anti-emetic actions. Cannabis use in other chronic pain conditions has resulted in “substitution” of pharmaceuticals, commonly opioid analgesics, for cannabis. Our previous research has shown that women with endometriosis in Australia are using mostly illicit sources of cannabis to manage their pain and other symptoms. We hypothesise that either a balanced THC:CBD oil or CBD alone will reduce pelvic pain and other symptoms in women with endometriosis. The primary aim of this study is to determine the efficacy and safety of two medicinal cannabis products compared to placebo in women with endometriosis.
Eligibility
Inclusion Criteria14
- Aged over 18 years.
- Self-reported pelvic pain, severe enough to seek medical attention.
- Diagnosis of endometriosis via laparoscopy (with or without histological confirmation), magnetic resonance imaging (MRI), or Ultrasound imaging by a medical doctor, with input from an imaging specialist with specific endometriosis expertise.
- Have not used illicit cannabis and/or prescribed cannabinoid-based medications in the previous three months.
- Report no current, or history of, hazardous cannabis use, or dependency.
- If sexually active and pregnancy is a possibility, agree to use appropriate contraception to prevent pregnancy during the study period.
- Agree to keep all study product stored in a secure location and not to share/distribute cannabis to any other individual.
- Agree not to drive while under the effects of medicinal cannabis.
- Willing to provide informed consent and adhere to the protocol.
- Residing in Australia during the trial period.
- Able to travel to designated radiology clinic for ultrasound scans.
- Able to travel to a Healius collection centre for blood tests.
- Has internet access (either via a mobile (Apple or Android) or tablet (Apple)) for logging outcomes via the OnTracka app.
- Ability to understand and speak English.
Exclusion Criteria7
- Have had endometriosis-related surgery in the previous six months or have any surgery planned during the study period.
- Started, stopped, or had a significant change in dosage of any endometriosis specific medication in the last three months. This includes contraceptives, GNRH-a, and neuroleptics (changes in ‘as needed’ medications such as analgesics are not reasons for exclusion).
- Have any current or past diagnoses that would be considered a risk to participation in the study, including but not limited to, schizophrenia spectrum and other psychotic disorders, bipolar-related disorders, dissociative disorders, personality disorders, cannabis use disorder, obsessive-compulsive related disorders, neurological disorders, or brain injury.
- Currently have any major haematological, endocrine, cerebrovascular, cardiovascular, coronary, pulmonary, gastrointestinal (particularly hepatic), renal, or neurological disease (determined by the medical monitoring team).
- Current usage of anticoagulants (e.g., warfarin, heparin or any other NOAC/DOAC medications) or any other medication, including supplements (e.g., vitamin E, Gingko), that causes blood thinning.
- Currently pregnant or breastfeeding or planning on becoming pregnant during the study period.
- Abnormal liver and kidney function tests as determined during screening process.
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Interventions
Arm 1: Balanced THC:CBD oil Participants will first undergo a run-in period (week 0-2) to determine their maximum dosage of interventional product. Participants will start with self-administering 0.40ml of THC:CBD oil (10mg/ml THC: 10mg/ml CBD) per day split into two doses 10-12 hours apart and ingested orally (0.20ml at breakfast and 0.20ml at dinner), providing a total starting dosage of 4mg of THC and CBD per day. This will be increased by 0.20ml per day every two to three days (based on patient preference) until participants report either (a) a 20% or greater reduction in their daily pelvic pain severity as measured on a 0-10 numeric rating scale (NRS), (b) they experience adverse psychoactive effects that are bothersome to the participant, or (c) they reach the maximum dosage of 20mg of THC per day. During the intervention period (week 3-26) participants will continue taking their maximum dosage via self-administration as determined during the run-in period. Arm 2: Cannabidiol (CBD) full spectrum extract Participants will first undergo a run-in period (week 0-2) to determine their maximum dosage of interventional product. Participants will start with self-administrating 0.40ml of CBD oil (100mg/ml CBD) per day split into two doses 10-12 hours apart and ingested orally (0.20ml at breakfast and 0.20ml at dinner), providing a total starting dosage of 40mg of CBD per day. This will be increased by 0.20ml per day every two to three days (based on patient preference) until participants report either (a) a 20% or greater reduction in their daily pelvic pain severity as measured on a 0-10 numeric rating scale (NRS), (b) they experience adverse psychoactive effects that are bothersome to the participant, or (c) they reach the maximum dosage of 150mg of CBD per day. During the intervention period (week 3-26) participants will continue taking their maximum dosage via self-administration as determined during the run-in period. Both Arm 1 and 2 will have an intervention duration of 26 weeks, inclusive of the two-week run-in period. Compliance will be measured by returning empty bottles twice during the intervention period.
Locations(1)
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ACTRN12624000328572