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
Plain Language Summary
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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