JMIR Publications

ABSTRACT

Background:

Existing evidence supports several countries introducing legislations to allow cannabis-based medicine as adjunctive treatment for the symptomatic relief of chronic pain, chemotherapy-induced nausea, spasticity in multiple sclerosis, epileptic seizures, depression, and anxiety. However, clinical trial participants do not represent the entire spectrum of disease and health status seen in patients currently accessing medicinal cannabis in practice.

Objective:

This study will collect real-world data to evaluate health-related quality of life and symptoms in patients prescribed medicinal cannabis oil formulations, and describe any differences over time from baseline, before starting therapy, to 3 months and 12 months on therapy.

Methods:

Adult patients newly prescribed medicinal cannabis oil by Authorised Prescribers and under the Special Access Schemes across clinics within Australia will be screened for eligibility and sent an invitation to participate. A sample size of 2142 is required with a minimum follow-up of 3 months. All participants will complete the EQ-5D, QLQ-C30, DASS21, Patients’ global impression of change, PROMIS Short Form v1.0 Sleep Disturbance 8b, and PROMIS Fatigue 13a/FACIT-Fatigue questionnaires. Patients with chronic pain conditions will also complete PROMIS Scale v1.0 - Pain Intensity 3a, and PROMIS Short Form v1.0 - Pain Interference 8a. Patients with movement disorders will also complete Neuro-QoL v1.0 – Upper Extremity Function (Fine Motor, ADL) – Short Form, and if Chorea is indicated, the Neuro-QoLTM Short Form v2.0 – HDQLIFE – Chorea 6a. All questionnaires will be administered at baseline, 2 weeks (titration), monthly to 3 months, then every 2 months up to one year.

Results:

Participant recruitment commenced in November 2020. By June 2021, 1095 patients had been screened for the study by 69 doctors in centres across six Australian states; Australian Capital Territory, New South Wales, Queensland, South Australia, Victoria, and Western Australia. Of the 1095 patients screened, 833 participants have completed questionnaires and remained on the study. Final results are expected to be published in 2022. Results from this study will show whether patient-reported outcomes improve in patients accessing prescribed medicinal cannabis from baseline to 3-months, and if any changes are maintained over a 12-month period. This study will also identify if there are differences in improvements in PROs between patients with different chronic conditions (e.g. chronic pain, multiple sclerosis, epilepsy, Parkinson’s disease, or cancer).

Conclusions:

This study protocol contains detailed methods that will be used across multiple sites in Australia. The findings from this study have potential to be integral to treatment assessment and recommendations for chronic pain sufferers and other patients with health indicators for accessing medicinal cannabis. Clinical Trial: ANZCTR Trial Registration: 12621000063819