ENDOCAN-1: A feasibility randomised controlled trial of the efficacy of a cannabinoid oral solution in the management of endometriosis-associated pain
Endometriosis
Participants will be randomised into one of two treatment arms, via an online randomisation tool. CBD arm: participants in the active arm will be given oral CBD solution for 12 weeks duration. The starting dose will be a solution of 0.5 mg/kg BID administered morning and evening and taken with food. The dose will be increased if there is ongoing pain and tolerable or no side effects, as per below: Week Dose (mg/kg b.i.d) 1 0.5 2 1 3 2 4 3.25 5 4.75 6 6.25 A maximum dose of 6.25 mg/kg BID will be permitted. At Week 6, participants will attend a research visit for re-supply. After 12 weeks of treatment, a follow up visit will be carried out 10 days after end of treatment. Placebo arm: Identical dosing regime as above for 12 weeks.
1. Women or assigned female at birth 2. Aged 18 years or over 3. Endometriosis identified at laparoscopy or imaging, performed within the last ten years 4. Self reported pelvic pain for more than six months 5. Weekly worst pain score of at least four on a numerical rating scale (NRS) on two or more occasions over the four weeks prior to randomisation 6. Willing not to take additional cannabinoids during the trial period 7. Willing to use effective contraception throughout the trial (if needed) 8. Willing and able to give informed consent 9. Willing to be contacted by text message
1. Pregnant, breastfeeding or actively trying to get pregnant 2. Post-menopausal (no periods for >12 months and not taking hormonal treatments to prevent periods, or bilateral oophorectomy performed) 3. Suicidal thoughts or severe depression within the past year 4. Current use (or within the last 1 month) of other cannabinoid or cannabis products, determined by urine dipstick test 5. Chronic alcohol abuse 6. History of severe liver disease (Alanine transaminase (ALT) and/or aspartate aminotransferase (AST) more than 3-times the upper limit of normal (ULN)) and bilirubin greater than 2 times the ULN, Or moderate to severe hepatic impairment (Child-Pugh class B or C) 7. Concomitant use of Sodium Valproate, Clobazam, Stiripentol, Everolimus 8. Hypersensitivity to any of the components of the formulation as defined in the IB 9. Taking part in another CTIMP or interventional non-CTIMP study