Lavender, Isobel;
McCartney, Danielle;
Marshall, Nathaniel;
Suraev, Anastasia;
Irwin, Chris;
D'Rozario, Angela L;
Gordon, Christopher J;
Saini, Bandana;
Grunstein, Ronald R;
Yee, Brendon;
McGregor, Iain;
Hoyos, Camilla M
Cannabinol (CBN; 30 and 300 mg) effects on sleep and next-day function in insomnia disorder (‘CUPID’ study): protocol for a randomised, double-blind, placebo-controlled, cross-over, three-arm, proof-of-concept trial
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Media type:
E-Article
Title:
Cannabinol (CBN; 30 and 300 mg) effects on sleep and next-day function in insomnia disorder (‘CUPID’ study): protocol for a randomised, double-blind, placebo-controlled, cross-over, three-arm, proof-of-concept trial
Contributor:
Lavender, Isobel;
McCartney, Danielle;
Marshall, Nathaniel;
Suraev, Anastasia;
Irwin, Chris;
D'Rozario, Angela L;
Gordon, Christopher J;
Saini, Bandana;
Grunstein, Ronald R;
Yee, Brendon;
McGregor, Iain;
Hoyos, Camilla M
Description:
<jats:sec><jats:title>Objective</jats:title><jats:p>Insomnia is the most prevalent sleep disorder, with few effective pharmacotherapies. Anecdotal reports and recent preclinical research suggest that cannabinol (CBN), a constituent of<jats:italic>Cannabis sativa</jats:italic>derived from delta-9-tetrahydrocannabinol, could be an effective treatment. Despite this, the isolated effects of CBN on sleep have yet to be systematically studied in humans.</jats:p></jats:sec><jats:sec><jats:title>Methods</jats:title><jats:p>The present protocol paper describes a randomised, double-blind, placebo-controlled, single-dose, three-arm, cross-over, proof-of-concept study which investigates the effects of CBN on sleep and next-day function in 20 participants with clinician-diagnosed insomnia disorder and an Insomnia Severity Index Score ≥15. Participants receive a single fixed oral liquid dose of 30 mg CBN, 300 mg CBN and matched placebo, in random order on three treatment nights; each separated by a 2-week wash-out period. Participants undergo overnight sleep assessment using in-laboratory polysomnography and next-day neurobehavioural function tests. The primary outcome is wake after sleep onset minutes. Secondary outcomes include changes to traditional sleep staging, sleep-onset latency and absolute spectral power during non-rapid eye movement (NREM) sleep. Tertiary outcomes include changes to sleep spindles during NREM sleep, arousal indices, absolute spectral power during REM sleep and subjective sleep quality. Safety-related and exploratory outcomes include changes to next-day simulated driving performance, subjective mood and drug effects, postural sway, alertness and reaction time, overnight memory consolidation, pre and post-sleep subjective and objective sleepiness; and plasma, urinary, and salivary cannabinoid concentrations. The study will provide novel preliminary data on CBN efficacy and safety in insomnia disorder, which will inform larger clinical trials.</jats:p></jats:sec><jats:sec><jats:title>Ethics and dissemination</jats:title><jats:p>Human Research Ethics Committee approval has been granted by Bellberry (2021-08-907). Study findings will be disseminated in a peer-reviewed journal and at academic conferences.</jats:p></jats:sec><jats:sec><jats:title>Trial registration number</jats:title><jats:p><jats:ext-link xmlns:xlink="http://www.w3.org/1999/xlink" ext-link-type="clintrialgov" xlink:href="NCT05344170">NCT05344170</jats:ext-link>.</jats:p></jats:sec>