This is a randomised, placebo-controlled, double-blinded, crossover pilot trial using novel brain imaging technology to comprehensively examine and localise differences in sleep and brain activation following a single dose of an oral cannabis extract in 20 patients with insomnia disorder.
Participants will receive all of the interventions (a single fixed dose of an oral cannabis extract or placebo) at random across two overnight sleep studies at the Woolcock Institute of Medical Research in Glebe. Each overnight sleep study will be scheduled at least one-week apart. The objective of this trial is to examine the efficacy of an oral cannabis extract on sleep, cognition and next-day function including driving performance in adults with insomnia disorder, compared to placebo.
This is a collaboration between the Lambert Initiative for Cannabinoid Therapeutics, University of Sydney, and the Woolcock Institute of Medical Research.
Principal Investigators: Professor Ron Grunstein and Dr Camilla Hoyos (Woolcock Institute of Medical Research)
Project Coordinator: Anastasia Suraev (University of Sydney)
Recruitment for this study has closed.
A review of the preclinical and clinical studies available that have investigated cannabinoids on sleep behaviour and in sleep disorders.
Results indicated that there is insufficient evidence to support routine clinical use of cannabinoid therapies for the treatment of any sleep disorder given the lack of published research and the moderate-to-high risk of bias identified within the majority of preclinical and clinical studies completed to-date. Promising preliminary evidence provides the rationale for future randomised controlled trials of cannabinoid therapies in individuals with sleep apnea, insomnia, post-traumatic stress disorder-related nightmares, restless legs syndrome, rapid eye movement sleep behaviour disorder, and narcolepsy. There is a clear need for further investigations on the safety and efficacy of cannabinoid therapies for treating sleep disorders using larger, rigorously controlled, longer-term trials.
This work was a collaboration between the Lambert Initiative for Cannabinoid Therapeutics, University of Sydney, and the Woolcock Institute of Medical Research.