Little Green Pharma is joining forces with Southern Cross University to study treatment of fibromyalgia syndrome using medicinal cannabis. Funding will be provided for a three-year PhD scholarship research supervision to SCU, studying the safety, tolerability and efficacy of medicinal cannabis in relieving pain and other symptoms in adult patients diagnosed with fibromyalgia.
The three-year project includes a Phase 2 randomised, double blinded, placebo-controlled clinical trial. LGP clinical researcher and Head of Research & Innovation, Dr Leon Warne will assist as a co-supervisor. Little Green Pharma will also supply the cannabis medicines used in the study.
Fibromyalgia currently affects approximately 2.7% of the global population. The syndrome is 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.
Existing treatment options for most people with the condition are extremely limited.
The three year study period will be conducted in three stages, starting with a literature review and survey. The final stage of 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.
Commenting on the research program, LGP Head of Research and Innovation Dr Leon Warne said, ‘LGP is proud to be associated with Southern Cross University in this important research study.
‘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.’
An exciting collaboration
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 twenty years.
‘This is a very exciting 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,’ she said.
‘Not only supporting research, but helping to develop future researchers in medicinal cannabis which is greatly needed.’
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 co-supervisor.
PhD student Inna Kurlyandchik said, ‘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.
1 Comment
I would be very interested in this result.
I was diagnosed with Fibromyalgia, tietze syndrome and chronic insomnia in 1998 and subsequently have developed IBS and MCS.
17 years ago (at the age of 50) I gave up 95% of pharams (use fore emergency only) for cannabis (vaping) and it saved my life. Unfortunately I have subsequently developed an intolerance to it and intermittently, just about everything else in my environment.
However still very interested and if possible would love to be kept up to date.