CompletedPhase 2ACTRN12619000714189

A single-dose, double-blind, placebo-controlled, randomised, crossover study of an oral cannabis-based medicine (ETC120) on sleep, cognition, and next-day function in adults with chronic insomnia disorder

A single-dose, double-blind, placebo-controlled, randomised, crossover study of an oral cannabis-based medicine (ETC120) on sleep quality and quantity in adults with chronic insomnia disorder

Sponsor

Woolcock Institute of Medical Research

Enrollment

20 participants

Start Date

Aug 19, 2019

Study Type

Interventional

Conditions

Insomnia

Summary

Anecdotally, cannabis is frequently reported by consumers to promote sleep. Indeed, a recent Australian survey found that sleep disorders were the fourth most indicated reason for using cannabis for medicinal reasons in a community sample of 1,700 users (Lintzeris et al., 2018). While improved sleep is one of the positive effects that cannabis users typically report, there is limited well-designed research using objective measures assessing the effects of cannabis on sleep quality and quantity. Moreover, no study to-date has examined the effects of cannabinoid medicine in people with chronic insomnia disorder. To address this gap, we will investigate the acute effects of a cannabinoid medicine (ETC120) on sleep and next-day function compared to placebo in patients with chronic insomnia disorder. This study will utilise novel high-density 256-channel EEG coupled with structural MRI to examine and localise differences in sleep depth and brain activation during both sleep and wakefulness following a single dose of ETC120 and placebo during an overnight sleep study. Daytime function including cognition, alertness and driving performance will also be assessed. As this is a pilot study, we aim to recruit 20 patients aged 35-60 years inclusive with a diagnosis of chronic insomnia disorder. Participants will be comprehensively screened for eligibility across 1-2 visits at the Woolcock Institute of Medical Research, Sydney. All participants will receive all of the interventions in a randomised and counterbalanced order during two overnight sleep studies at the sleep laboratory at the Woolcock Institute of Medical Research. Each overnight sleep study will take approximately 24 hours to complete and will be scheduled at least one-week apart to avoid any carryover effects. This aim of this study is to provide high-quality pilot data using novel multimodal neuroimaging technologies to comprehensively examine the acute effects of a cannabinoid medicine on sleep in patients with chronic insomnia disorder.

Eligibility

Sex: Both males and femalesMin Age: 25 YearssMax Age: 65 Yearss

Inclusion Criteria5

Males and females aged 25 – 65 years old,
Chronic insomnia disorder diagnosed by a sleep physician or psychologist,
Insomnia Severity Index (ISI) score greater than or equal to 15,
Insomnia symptoms for more than 3 times per week and present for longer than 3 months,
Proficiency in English, and capable and willing to provide informed consent to the study procedures.

Exclusion Criteria24

Medical condition or medication that is the cause of the insomnia;
Known hypersensitivity to cannabinoids;
No reported use of cannabis within the past 3 months (or at the medical officer’s discretion) and confirmed by at least one negative urine drug screen (UDS);
Past or present history of cannabis dependence (ICD-10 criteria or at the medical officer’s discretion);
Sleep apnea (defined as Apnea Hypopnea Index [AHI] >15 and Oxygen Desaturation Index [ODI]>10) or sleep-related movement disorder based on in-laboratory polysomnography;
Delayed sleep phase syndrome (determined on clinical interview, actigraphy and sleep diary at screening);
Any medical condition related to an abnormal EEG (i.e. epilepsy, brain injury);
Shift-work, transmeridian travel (2 time zones) over the last one month;
History of major psychiatric disorder in the past 12 months except clinically-managed mild depression;
History of suicide attempt or current suicide ideation (score greater than 0 on Q9 to PHQ-9 at screening);
Current evidence of clinically significant disease [including participants who lack capacity and/or whose cognitive decline indicates disorientation to person/place/time and/or situation], or malignancy or chronic pain that in the opinion of the investigator(s) could affect the participant's safety or interfere with the study assessments;
Clinically relevant cardiovascular abnormalities as determined by 12-lead electrocardiogram (ECG) at screening;
Pregnancy or lactation - males and females shall be advised to use reliable contraception for the duration of drug therapy and a urine pregnancy test will be performed for female participants where necessary;
Use of any CNS-active drugs (including antidepressants, opioids, benzodiazepines) for the past 3 months or at the medical officer’s discretion;
Use of medications that may have a clinically significant impact upon the metabolism and excretion of cannabinoids at the medical officer’s discretion (e.g. CYP450 enzyme inducers/inhibitors);
History of drug or alcohol dependency or abuse within approximately the past 2 years;
Urinary drug test positive for drugs (cannabis, amphetamines, and cocaine) at screening visit;
Excessive caffeine use that in the opinion of the investigator contributes to the participant's insomnia, or if participant is unable to abstain from caffeine use 24 hours prior to and during each overnight sleep study;
Inability to refrain from alcohol consumption 24 hours prior to and during each overnight sleep study;
Individuals who regularly smoke or at the medical officer’s discretion;
Medical conditions that result in frequent need to get out of bed (e.g. nocturia);
Used any modality of treatment for insomnia, including CBT within 3 months before screening or at the medical doctor's discretion;
Unable to undergo MRI brain imaging due to implanted device (e.g. defibrillator, pacemaker) as identified via MRI screening questionnaire;
Required to complete mandatory drug testing (e.g. workplace testing, court order).

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Interventions

This randomised, double-blind, placebo-controlled, crossover pilot study will assess the effects of a single dose of an oral cannabinoid medicine on sleep and next-day function relative to placebo in

This randomised, double-blind, placebo-controlled, crossover pilot study will assess the effects of a single dose of an oral cannabinoid medicine on sleep and next-day function relative to placebo in patients with chronic insomnia disorder. The investigational product is an oral solution containing cannabinoids in medium-chain triglycerides (MCT) oil ('ETC120'). Participants will receive all of the interventions (a single fixed dose of ETC120 or matched placebo - both 2mL) in a randomised and counterbalanced order across two overnight sleep studies at the Woolcock Institute of Medical Research. The study investigator will instruct and directly observe the participant self-administer the dose of the oral solution via a plastic syringe, pre-filled by the study medical doctor same day. Each overnight sleep study will be scheduled at least one-week apart to avoid any carryover effects (washout period).