None listed
Conditions
Brief 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 9 women and those assigned female at birth in Australia (~830,000 people) and has no cure. My research has shown that patients often have to make impossible choices between being in pain, and the worry of dependence, addiction and impairment due to the current drug choices. Effective pain relief with a low to negligible risk of addiction is the holy grail for people with endometriosis. Various phytochemicals (mainly cannabinoids) from Cannabis spp have 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, by cannabis. Our previous research has shown that women with endometriosis in Australia and New Zealand are using cannabis, mostly from illicit sources, to manage their pain and other symptoms. We hypothesise that usage of either CBD isolate alone or in combination with THC containing canabis flower will reduce pelvic pain severity, and presentations to the emergency department. The primary aim of this project is to determine the feasibility, safety and acceptability of two different medicinal cannabis interventions in people with endometriosis
Interventions
Arm 1: Cannabidiol (CBD) Oil alone
Starting with 0.5ml of CBD oil (CBD isolate 100mg/mL) per day split into two doses 10-12 hours apart and ingested orally (0.25ml breakfast and 0.25ml dinner), providing a total dosage of 50mg of CBD per day. This will be increased by 0.2ml 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), or (b) they
Arm 1: Cannabidiol (CBD) Oil alone Starting with 0.5ml of CBD oil (CBD isolate 100mg/mL) per day split into two doses 10-12 hours apart and ingested orally (0.25ml breakfast and 0.25ml dinner), providing a total dosage of 50mg of CBD per day. This will be increased by 0.2ml 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), or (b) they reach the maximum dosage of 300mg of CBD per day Arm 2: CBD Oil + vapourised Tetrahydrocannabinol (THC) containing cannabis flower as required. Starting dosage and dosage finding as per Arm 1. In addition, all participants will be provided with a TGA-approved vaporiser and 10g of a moderate THC cannabis flower (14% THC, <1% CBD) per month. Participants will be advised that if their pelvic pain is > 6/10 they may take up to two inhalations per session (equivalent ~5-7mg THC per inhalation) using the Foltin Uniform Puff Procedure where the user inhales for 5s and is then followed by a 10 s breath hold, then exhalation. They then wait for 10 minutes and decide if they need the second inhalation to reduce their pain to a manageble level. This process can be repeated up to 3 times per day, with at least 120 minutes between sessions. Both Arm 1 and 2 will have a total duration of 3 months of intervention. Compliance will be measured by returning of products at trial conclusion and then (a) measurement of remaining CBD oil in ml and (b) weighing of returned cannabis flower.
Sponsors
Deakin University
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
20 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Aged 20 years and over; able to read and write English fluently, be residing in the state of Victoria for the duration of the trial period, Diagnosis of endometriosis via laparoscopy, MRI or Ultrasound imaging by a medical doctor with input from an imaging specialist with specific endometriosis expertise; Have not used illicit cannabis or prescribed cannabinoid-based medications in the previous three months; Report no current, or history of, hazardous cannabis use or dependency; Agree to keep all study product stored in a secure location and not to share/distribute cannabis to any other individual; has access to a smartphone (either iOS or Android). If sexually active and pregnancy is a possibility, agree to use appropriate contraception to prevent pregnancy during the study period, agree not to consume alcohol during the titration and active phase of the trial, agree not to participate in any other clinical trial during the titration and active phase of the trial.
Exclusion criteria
Endometriosis-related surgery in the previous six months; Must not have started, stopped or had a significant change in dosage of any endometriosis specific medication in the last three months including contraceptives, GNRH-a, and neuroleptics (changes in ‘as needed’ medications such as analgesics are not reasons for exclusion); Upon review of medical or psychiatric history, must not have any current or past diagnosis that would be considered a risk to participation in the study, such as schizophrenia, psychosis, bipolar disorder, panic disorder, major depressive disorder, dissociative disorder, cannabis use disorder or obsessive-compulsive disorder; Currently have any major haematological, endocrine, cerebrovascular, cardiovascular, coronary, pulmonary, gastrointestinal (particularly hepatic), renal or neurological disease (determined by the medical monitoring team). Currently taking Immune modulators (e.g., cyclosporine), Mood-altering drugs (e.g., lithium carbonate) – not including antidepressants aside from tricyclics (mentioned below), Blood thinners (e.g., warfarin), Monoamine oxidase inhibitors (e.g., selegiline, phenelzine), Anti-arrhythmics (e.g., quinidine, disopyramide), Hypoglycaemics (e.g., insulin), Antiepileptics/anticonvulsants (e.g., phenytoin, valproic acid), Anti-HIV drugs (e.g., saquinavir), Antineoplastics (e.g., methotrexate), Barbiturates, Theophylline (1,3-dimethylxanthine), Cardiac glycosides (e.g., digoxin), St John’s wort. Known allergy to any of the compounds in the investigational products (e.g CBD, THC). Participation in another clinical trial during the past 30 days.
Outcome results
None listed