Cannabidiol (CBD) and Δ9-tetrahydrocannabinol (THC) for chronic insomnia disorder (‘CANSLEEP’ trial): protocol for a randomised, placebo-controlled, double-blinded, proof-of-concept trial

IntroductionInsomnia 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 daytim...

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Published inBMJ open Vol. 10; no. 5; p. e034421
Main Authors Suraev, Anastasia, Grunstein, Ronald R, Marshall, Nathaniel S, D'Rozario, Angela L, Gordon, Christopher J, Bartlett, Delwyn J, Wong, Keith, Yee, Brendon J, Vandrey, Ryan, Irwin, Chris, Arnold, Jonathon C, McGregor, Iain S, Hoyos, Camilla M
Format Journal Article
LanguageEnglish
Published London BMJ Publishing Group LTD 18.05.2020
BMJ Publishing Group
SeriesProtocol
Subjects
Cannabidiol
Clinical trials
Electroencephalography
Insomnia
Pharmacology and Therapeutics
Tetrahydrocannabinol
THC
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Abstract IntroductionInsomnia 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 analysisA 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 disseminationEthics 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 numberANZCTRN12619000714189.
AbstractList 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.
IntroductionInsomnia 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 analysisA 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 disseminationEthics 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 numberANZCTRN12619000714189.
Author Hoyos, Camilla M
Vandrey, Ryan
Marshall, Nathaniel S
Yee, Brendon J
Arnold, Jonathon C
Suraev, Anastasia
Wong, Keith
Gordon, Christopher J
Irwin, Chris
D'Rozario, Angela L
Grunstein, Ronald R
Bartlett, Delwyn J
McGregor, Iain S
AuthorAffiliation 9 The University of Sydney, Faculty of Medicine and Health, Discipline of Pharmacology , Sydney , New South Wales , Australia
2 The University of Sydney, Lambert Initiative for Cannabinoid Therapeutics , Sydney , New South Wales , Australia
6 The University of Sydney, Faculty of Medicine and Health, Susan Wakil School of Nursing and Midwifery , Sydney , New South Wales , Australia
7 Behavioral Pharmacology Research Unit , Johns Hopkins University , Baltimore , Maryland , USA
3 The University of Sydney, Faculty of Science, School of Psychology , Sydney , New South Wales , Australia
1 Woolcock Institute of Medical Research, Centre for Sleep and Chronobiology , Sydney , New South Wales , Australia
4 The University of Sydney, Brain and Mind Centre , Sydney , New South Wales , Australia
5 RPA-Charles Perkins Centre , Royal Prince Alfred Hospital , Sydney , New South Wales , Australia
8 Menzies Health Institute Queensland, School Allied Health Sciences , Griffith University , Gold Coast , Queensland
AuthorAffiliation_xml – name: 2 The University of Sydney, Lambert Initiative for Cannabinoid Therapeutics , Sydney , New South Wales , Australia
– name: 1 Woolcock Institute of Medical Research, Centre for Sleep and Chronobiology , Sydney , New South Wales , Australia
– name: 4 The University of Sydney, Brain and Mind Centre , Sydney , New South Wales , Australia
– name: 9 The University of Sydney, Faculty of Medicine and Health, Discipline of Pharmacology , Sydney , New South Wales , Australia
– name: 5 RPA-Charles Perkins Centre , Royal Prince Alfred Hospital , Sydney , New South Wales , Australia
– name: 3 The University of Sydney, Faculty of Science, School of Psychology , Sydney , New South Wales , Australia
– name: 6 The University of Sydney, Faculty of Medicine and Health, Susan Wakil School of Nursing and Midwifery , Sydney , New South Wales , Australia
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– name: 7 Behavioral Pharmacology Research Unit , Johns Hopkins University , Baltimore , Maryland , USA
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  givenname: Angela L
  surname: D'Rozario
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– sequence: 7
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– sequence: 8
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– sequence: 9
  givenname: Ryan
  surname: Vandrey
  fullname: Vandrey, Ryan
  email: camilla.hoyos@sydney.edu.au
  organization: Behavioral Pharmacology Research Unit, Johns Hopkins University, Baltimore, Maryland, USA
– sequence: 10
  givenname: Chris
  surname: Irwin
  fullname: Irwin, Chris
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– sequence: 11
  givenname: Jonathon C
  surname: Arnold
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  givenname: Iain S
  surname: McGregor
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  surname: Hoyos
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  email: camilla.hoyos@sydney.edu.au
  organization: The University of Sydney, Brain and Mind Centre, Sydney, New South Wales, Australia
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Copyright Author(s) (or their employer(s)) 2020. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.
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Snippet IntroductionInsomnia is a highly prevalent and costly condition that is associated with increased health risks and healthcare utilisation. Anecdotally,...
INTRODUCTIONInsomnia is a highly prevalent and costly condition that is associated with increased health risks and healthcare utilisation. Anecdotally,...
Introduction Insomnia is a highly prevalent and costly condition that is associated with increased health risks and healthcare utilisation. Anecdotally,...
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StartPage e034421
SubjectTerms Cannabidiol
Clinical trials
Electroencephalography
Insomnia
Pharmacology and Therapeutics
Tetrahydrocannabinol
THC
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Title Cannabidiol (CBD) and Δ9-tetrahydrocannabinol (THC) for chronic insomnia disorder (‘CANSLEEP’ trial): protocol for a randomised, placebo-controlled, double-blinded, proof-of-concept trial
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