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

Phase 1

Completed

• Conditions: Insomnia; Neurological - Other neurological disorders

• Registration Number: ACTRN12619000714189
• Lead Sponsor: Woolcock Institute of Medical Research

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-05-13
• Study Completion: 2021-10-19
• Last Update Posted: 14 March 2022

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

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

Exclusion Criteria

1. Medical condition or medication that is the cause of the insomnia;
2. Known hypersensitivity to cannabinoids;
3. 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);
4. Past or present history of cannabis dependence (ICD-10 criteria or at the medical officer’s discretion);
5. 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;
6. Delayed sleep phase syndrome (determined on clinical interview, actigraphy and sleep diary at screening);
7. Any medical condition related to an abnormal EEG (i.e. epilepsy, brain injury);
8. Shift-work, transmeridian travel (2 time zones) over the last one month;
9. History of major psychiatric disorder in the past 12 months except clinically-managed mild depression;
10. History of suicide attempt or current suicide ideation (score greater than 0 on Q9 to PHQ-9 at screening);
11. 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;
12. Clinically relevant cardiovascular abnormalities as determined by 12-lead electrocardiogram (ECG) at screening;
13. 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;
14. Use of any CNS-active drugs (including antidepressants, opioids, benzodiazepines) for the past 3 months or at the medical officer’s discretion;
15. 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);
16. History of drug or alcohol dependency or abuse within approximately the past 2 years;
17. Urinary drug test positive for drugs (cannabis, amphetamines, and cocaine) at screening visit;
18. 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;
19. Inability to refrain from alcohol consumption 24 hours prior to and during each overnight sleep study;
20. Individuals who regularly smoke or at the medical officer’s discretion;
21. Medical conditions that result in frequent need to get out of bed (e.g. nocturia);
22. Used any modality of treatment for insomnia, including CBT within 3 months before screening or at the medical doctor's discretion;
23. Unable to undergo MRI brain imaging due to implanted device (e.g. defibrillator, pacemaker) as identified via MRI screening questionnaire;
24. Required to complete mandatory drug testing (e.g. workplace testing, court order).

Study & Design

• Study Type: Interventional
• Study Design: Not specified