Entoura has released clinical trial results demonstrating its medicinal cannabis oil product is an effective treatment for insomnia.
The randomised, double-blind, placebo-controlled, crossover study was undertaken at the National Institute of Integrative Medicine (NIIM), led by Associate Professor Dr Karin Ried, with a research grant from Entoura.
A total of 29 participants with self-reported insomnia according to the Insomnia Severity Index (ISI) took part in the six-week trial, with tolerability assessed by daily recordings of side effects and effectiveness assessed by saliva midnight melatonin levels and validated questionnaires.
Results demonstrated that Entoura EMC 10:15 medicinal cannabis oil was generally well tolerated, and effective in treating insomnia.
Melatonin levels significantly improved in the active group compared to decreasing levels in the placebo group. The total sleep score assessed by the ISI also improved significantly, resulting in higher sleep satisfaction, daily functioning and quality of life.
Sleep time improved by an average of 30 minutes per night as well as quality of sleep compared to placebo. The active group also reported feeling significantly more clear-headed and tranquil after the intervention.
Entoura founder Professor Ian Brighthope said: “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, Entoura 10:15 regulates the sleep-wake cycle, helps to naturally restore melatonin levels and consequently improve sleep patterns and quality of life for insomnia patients.”
Dr Ried added: “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.”
Chronic insomnia is estimated to effect 14.8% of Australian adults and is associated with an increased risk of serious health issues including cardiovascular disease, diabetes, obesity, chronic pain, anxiety and depression.
NIIM is in the process of submitting the study for journal publication.