Media release: 13 October 2021
Entoura has achieved a significant milestone with the release of clinical trial results demonstrating its medicinal cannabis product Entoura 10:15 Oil is an effective treatment for people suffering from insomnia.
The National Institute of Integrative Medicine (NIIM) has released the preliminary findings of this randomised, double-blind, placebo controlled, cross-over study and is in the process of submitting for journal publication.
This study is the first of its kind to include midnight melatonin levels to assess the effect of medicinal cannabis oil on sleep quality in adults with insomnia.
Key outcomes of the trial included:
- Midnight melatonin levels significantly improved compared to placebo
- Effective in improving duration and quality of sleep
- Improved quality of life and daily functioning
- Generally well tolerated
The trial was undertaken at NIIM and led by principal investigator A/Prof Dr Karin Ried and supported with a research grant from Entoura.
The prevalence of chronic insomnia in Australia has been estimated at 14.8%1 and is associated with an increased risk of serious health issues including cardiovascular disease, diabetes, obesity, chronic pain, anxiety and depression. Current pharmacotherapy options for the treatment of insomnia can have various drawbacks including next day drowsiness and longer term dependence and tolerance.
Entoura’s founder Professor Ian Brighthope says “The purpose of this trial was to produce results for a pharmacotherapy with a different mode of action that can provide a safe and effective alternative to current medications. By interacting with the body’s endocannabinoid system, the Entoura 10:15 medicinal cannabis formulation regulates the sleep-wake cycle and helps to naturally restore melatonin levels and consequently improve sleep patterns and quality of life for insomnia patients.”
The objective of the trial was to assess the tolerability and effectiveness of the Entoura 10:15 medicinal cannabis oil on sleep in adults with insomnia in a randomised, cross-over, double-blind, placebo-controlled 6-week trial.
A total of 29 participants with self-reported insomnia (assessed by the Insomnia Severity Index (ISI)) completed the cross-over trial. Tolerability was assessed by daily recordings of side effects and effectiveness was assessed by saliva midnight melatonin levels and a series of validated questionnaires.
Results demonstrated that Entoura EMC 10:15 medicinal cannabis oil was generally well tolerated, and was found to be effective in improving sleep, melatonin levels, and quality of life.
Melatonin levels significantly improved in the active group compared to decreasing levels in the placebo group. The total sleep score assessed by the ISI improved significantly in the active group compared to placebo, resulting in higher sleep satisfaction, daily functioning and quality of life in the active group. Medicinal cannabis improved sleep time by an average of 30 minutes per night as well as quality of sleep compared to placebo. Furthermore, the active group felt significantly more clear-headed and more tranquil after the intervention compared to placebo.
The release of these results is great news for prescribers hoping to access an Australian grown and manufactured THC:CBD balanced oil for approved patients struggling to manage their insomnia with traditional pharmaceuticals. For practitioners who wish to learn more about Entoura’s products, please register to the Entoura Cannabis Support Portal.
Principal Investigator, A/Prof. Dr Karin Ried, said: “We are pleased to have completed a robust study design measuring the effects of medicinal cannabis in the treatment of insomnia. To our knowledge, our trial is the first to include midnight melatonin levels to assess the effect of medicinal cannabis oil on sleep quality in adults with insomnia, which provided a very useful and objective outcome measure. The results of this study demonstrate significant improvements with sleep quality and duration which then lead to improved daily productivity and functionality.”
Entoura’s General Manager, Clare Barker said: “The release of these results is an exciting part of Entoura delivering on our vision of opening pathways for practitioner-patient treatment and our commitment to high quality medicine with validated clinical evidence. The data provides clear evidence to give prescribers confidence in treating their insomnia patients with Entoura’s 10:15 Oil and contributes to our ongoing clinical trial program”.
Entoura is an Australian owned and operated healthcare company established in 2018 by Professor Ian Brighthope, developing and supplying high quality medicinal cannabis products supported by healthcare professional training and education programs. Entoura invests significantly into local clinical trials and has recently completed a study for the use of medicinal cannabis in patients with insomnia. Entoura actively supports and contributes to improving legislation around key issues such as medicinal cannabis access, driving and DVA funding.
About Entoura 10:15 (Active product in clinical trial)
Entoura 10:15 was launched in Australia in April 2020 and has been used extensively for Insomnia, Chronic pain, Cancer pain and Anxiety.
This product is 100% Australian grown cannabis sativa, extracted in Australia and formulated under GMP conditions with MCT (medium chain triglycerides).
Active ingredients: Each 1 mL of Entoura 10:15 Oil contains: 10 mg Tetrahydrocannabinol (THC) and nominally 15 mg Cannabidiol (CBD), and lesser amounts of other cannabinoids and naturally occurring terpenes.
For further information, contact Entoura.
- Chronic insomnia disorder in Australia, A report to the Sleep Health Foundation – July 2019