Australian researchers are reporting the initial results from the world’s first placebo-controlled clinical trial testing the efficacy of medicinal cannabis in treating chronic insomnia. The results reveal statistically significant, and dose responsive, improvements to sleep quality using a novel cannabinoid formulation.

Although anecdotal reports abound elucidating the positive relationship between cannabis and sleep, there has been very little rigorous specific study into whether cannabis can help chronic insomnia. The data suggests it may help, but many prior trials exploring the effects of cannabinoids have focused primarily on other health conditions, with sleep being evaluated as a secondary outcome.

This Australian study began in 2018 and set out to explore the effect of a particular proprietary cannabinoid formulation on subjects with chronic insomnia. The study was funded by medical cannabis company Zelira Therapeutics, but independently conducted by a research team from the University of Western Australia. In an email to New Atlas, Peter Eastwood, lead researcher on the project, notes 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. 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.

Sleep quality was measured using subjective responses, wrist-based sleep trackers, and a questionnaire-based clinical tool called the Insomnia Severity Index (ISI). Alongside objective increases in overall time spent asleep, and subjective improvements in rested feelings upon waking, the results 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.

The specific proprietary cannabinoid formulation used in the study has not been revealed. Currently it is simply dubbed ZTL-101, and Eastwood tells New Atlas it is a combination of THC and CBD. The particular ratio has not been disclosed.

“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. “The fact that ZTL-101 treatment achieved statistically significant, dose responsive improvements across a broad range of key insomnia indices is impressive, particularly given the relatively short two-week dosing window.”

The trial has not been peer-reviewed or published in a journal, but these early results do suggest the treatment has no serious adverse effects. Eastwood also suggests efficacy may be increased by higher doses and longer term use, although this particular trial was not designed to answer those particular questions.

“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 says. “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 in 2020.

Sources: University of Western Australia, Zelira Therapeutics