Positive data is in from the world’s first placebo-controlled clinical trial that is testing the efficacy of medicinal marijuana in treating chronic insomnia.

Australian researchers have revealed the initial results that show statistically significant, and dose responsive, improvements to sleep quality using a novel cannabinoid formulation.

The Australian study began in 2018 and was funded by medical marijuana company Zelira Therapeutics. Conducted by a research team from the University of Western Australia, the study set out to explore the effect of a particular proprietary cannabinoid formulation on subjects with chronic insomnia.

In an email to New Atlas, lead researcher Peter Eastwood said that although this was a company-sponsored trial, the study was independent and none of the research team had any financial affiliation with the company.

The trial recruited 23 subjects with chronic insomnia and the double-blind, crossover trial assigned each subject either an active dose or a placebo for two weeks. The formulation was administered as an oil under the tongue, and subjects were allowed to take either a single or double dose depending on their symptoms.

Researchers studied the sleep quality by measuring subjective responses, wrist-based sleep trackers, and a questionnaire-based clinical tool called the Insomnia Severity Index (ISI).

There were objective increases in overall time spent asleep, and subjective improvements in rested feelings upon waking. The results also showed significant dose-responsive reductions in ISI scores.

On average, the subjects displayed a 26-percent reduction in ISI scores compared to placebo, and for those taking a higher dose that reduction reached 36 percent. This ISI reduction on the highest dose resulted in a reclassification of insomnia diagnosis from moderate to subclinical.

“This study represents the most rigorous clinical trial ever undertaken to assess the therapeutic potential of medicinal cannabis to treat the symptoms of chronic insomnia,” says Eastwood. “

“Positive patient experiences with minimal side-effects are critical to the success of any insomnia drug and highlights the potential for ZTL-101 to address a key area of unmet need,” Eastwood added. “It is likely that further improvements in efficacy could be achieved by dosing over a longer period and potentially at higher doses.”

Zelira Therapeutics plans to commercially release this cannabinoid formulation as an insomnia treatment later this year.

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