People with fibromyalgia syndrome (or FMS) will take part in a groundbreaking new trial to see how effective medicinal cannabis is to relieve their pain.

Southern Cross University has partnered with Little Green Pharma (LGP) to undertake the study, with LGP funding a three-year PhD Scholarship and medicinal cannabis products for the research project.

LGP Head of Research and Innovation Dr Leon Warne said the project will assess the safety, tolerability and efficacy of medicinal cannabis in relieving pain and other symptoms in adult patients diagnosed with FMS.

The project, which is intended to run over a three-year period, will be conducted in three stages starting with a literature review and survey.

The final stage, a Phase 2 randomised, double blinded, placebo-controlled clinical trial, is planned to begin recruitment in 2022 and uses medicinal cannabis in a 1 THC: 1 CBD ratio versus a placebo for a three-month period with follow-ups for a further six months post-trial.

“FMS is a debilitating disease and knowing that LGP is doing its part to assist in a clinical trial into the effectiveness of medicinal cannabis in treating FMS sufferers goes to the heart of our goal of providing a cost-effective therapy to enhance the quality of life of patients," Dr Warne said.

The Principal Investigator for this research undertaken by Southern Cross University is Dr Janet Schloss. Dr Schloss is part of the National Centre for Naturopathic Medicine as the Clinical Research Fellow conducting clinical trials and has also been in private practice as a Naturopath and Nutritionist for over 20 years.

Dr Janet Schloss

Dr Schloss said it was a great collaboration and "we are so happy to be pairing with one of the most ethical cannabis companies in Australia who are invested in helping research in this space".0

" Not only supporting research, but helping to develop future researchers in medicinal cannabis which is greatly needed,”

she said.

Under the Scholarship grant agreement, LGP will provide scholarship funding to support PhD candidate Inna Kurlyandchik over a three-year period, with Dr Leon Warne to support as a cosupervisor.

PhD student Inna Kurlyandchik said “Fibromyalgia is a complex condition with limited treatment options available. Last year we undertook a systematic review and found that medicinal cannabis has potential to reduce pain and improve the quality of life in fibromyalgia patients.

"I would like to express my gratitude for the PhD scholarship provided to me by Little Green Pharma LTD and Southern Cross University, which will allow me to build upon previous research in this area and further understand safety and efficacy of medicinal cannabis in treatment of this complex disorder.”

LGP will provide supplies of its balanced LGP Classic 10:10 medicinal cannabis oil as well as the placebo – an oil-based product similar in texture and smell - with which to conduct the trial.

The trial will be run at the Griffith University’s Clinical Trial Unit with clinicians from the Gold Coast University Hospital and private practice, with patients recruited from the public and private sectors via clinician referral. Research results will be shared via peer-reviewed scientific publications and conferences during the three-year project timeline.

ABOUT FMS

FMS affects approx. 2.7% of the global population1 and is a syndrome characterised by chronic widespread pain, sleep disturbances, morning stiffness, severe fatigue and cognitive dysfunction, often accompanied by other somatic and psychological impairments including mood changes, depression, anxiety, irritable bowel syndrome, vulvodynia, interstitial cystitis, chronic prostatitis, temporomandibular joint dysfunction and headaches. Treatment options are limited for people suffering FMS with previous studies demonstrating medicinal cannabis may be beneficial for some people suffering FMS.