EndoCannED – The effect of Medicinal Cannabis on emergency department presentations in people with endometriosis: a randomised, controlled feasibility study

Phase 2

Active, not recruiting

• Conditions: endometriosis; Reproductive Health and Childbirth - Menstruation and menopause; Alternative and Complementary Medicine - Other alternative and complementary medicine; Reproductive Health and Childbirth - Other reproductive health and childbirth disorders

• Registration Number: ACTRN12622001560785
• Lead Sponsor: Deakin University

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2022-12-19
• Last Update Posted: 9 September 2024

Recruitment & Eligibility

• Status: Active, not recruiting
• Sex: Female
• Target Recruitment: 12

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified