Introduction Insomnia is a highly prevalent and costly condition that is associated with increased health risks and healthcare utilisation. Anecdotally, cannabis use is frequently reported by consumers to promote sleep. However, there is limited research on the effects of cannabis on sleep and daytime function in people with insomnia disorder using objective measures. This proof-of-concept study will evaluate the effects of a single dose of an oral cannabis-based medicine on sleep and daytime function in participants with chronic insomnia disorder.
Methods and analysis A randomised, crossover, placebo-controlled, single-dose study design will be used to test the safety and efficacy of an oral oil solution (‘ETC120’) containing 10 mg Δ9-tetrahydrocannabinol (THC) and 200 mg cannabidiol (CBD) in 20 participants diagnosed with chronic insomnia disorder. Participants aged 35–60 years will be recruited over an 18-month period commencing August 2019. Each participant will receive both the active drug and matched placebo, in a counterbalanced order, during two overnight study assessment visits, with at least a 1-week washout period between each visit. The primary outcomes are total sleep time and wake after sleep onset assessed via polysomnography. In addition, 256-channel high-density electroencephalography and source modelling using structural brain MRI will be used to comprehensively examine brain activation during sleep and wake periods on ETC120 versus placebo. Next-day cognitive function, alertness and simulated driving performance will also be investigated.
Ethics and dissemination Ethics approval was received from Bellberry Human Research Ethics Committee (2018-04-284). The findings will be disseminated in a peer-reviewed open-access journal and at academic conferences.
Trial registration number ANZCTRN12619000714189.
- high-density EEG
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Contributors AS, RRG, NSM, ALD, CJG, DJB, KW, BJY, RV, CI, JCA, ISM and CMH were involved in the methodological design and drafting of the trial protocol. RRG and CMH are the medical and non-medical principal investigator, respectively, who have overall responsibility for the design, conduct and decision to submit for publication. NSM is the trial statistician who designed and wrote the analysis plan. AS is the trial coordinator responsible for collecting trial data. AS drafted the manuscript. All authors read and approved the final manuscript.
Funding This study is funded by the Lambert Initiative for Cannabinoid Therapeutics, a philanthropically funded centre for cannabinoid research at the University of Sydney. AS was supported by the Australian Government Research Training Program (RTP) and the Vice-Chancellor’s Research Scholarship (VCRS) at the University of Sydney. CMH (APP1104003) and ALD (APP1107716) were supported by Dementia Research Development Fellowships of the Australian National Health and Medical Research Council-Australian Research Council (NHMRC-ARC). RRG was supported by an NHMRC Senior Principal Research Fellowship (APP1106974). The investigational product was purchased from Linnea (Ticino, Switzerland) who were not involved in the conception or design of this study.
Competing interests ISM is Academic Director of the Lambert Initiative for Cannabinoid Therapeutics. He has served as an expert witness in various medicolegal cases involving cannabis, has received honoraria from Janssen, is currently a consultant to Kinoxis Therapeutics, and has received research funding and fellowship support from the Lambert Initiative for Cannabinoid Therapeutics, National Health and Medical Research Council (NHMRC) and Australian Research Council. He holds a variety of patents for cannabinoid and non-cannabinoid therapeutics. RV has received financial compensation from Zynerba Pharmaceuticals, Canopy Health Innovations and Brain Solutions. JCA is Deputy Academic Director of the Lambert Initiative for Cannabinoid Therapeutics. He has served as an expert witness in various medicolegal cases involving cannabis and recently served as a temporary advisor to the WHO on their review of cannabis and the cannabinoids. His research is funded by the NHMRC, Canopy Growth Corporation and the Lambert Initiative for Cannabinoid Therapeutics. JCA also holds several patents on novel cannabinoid therapies. All other authors have no conflicts of interest to disclose.
Patient and public involvement Patients and/or the public were not involved in the design, or conduct, or reporting or dissemination plans of this research.
Patient consent for publication Not required.
Provenance and peer review Not commissioned; externally peer reviewed.