The CANabidiol Use for RElief of Short Term Insomnia

Phase 2

Completed

• Conditions: Sleep Disturbance; Insomnia; Insomnia Type; Sleep Disorder; Insomnia, Transient; Insomnia Due to Anxiety and Fear; Insomnia Due to Other Mental Disorder
• Interventions: Drug: 50 mg Cannabidiol (CBD); Drug: Placebo; Drug: 100 mg Cannabidiol (CBD)

• Registration Number: NCT05253417
• Lead Sponsor: Bod Australia

Brief Summary

This study aims to investigate the effect of 50 mg and 100 mg per day oral CBD product versus a placebo over 8 weeks on insomnia severity in adults aged 18-65 years old with insomnia symptoms.

Detailed Description

This is a double-blind, randomised, parallel-group, placebo-controlled study of 8 weeks of oral CBD at 50 or 100 mg per day versus placebo in 198 participants with insomnia symptoms as classified by an Insomnia Severity Index (ISI) score of 8-21. Participants will be recruited voluntarily and are able to withdraw at any time. The study will be conducted online with telehealth consults where required.

Study Timeline

• Study First Submitted: 2021-12-20
• Study First Submitted QC: 2022-02-22
• Study First Posted: 2022-02-23
• Study Start: 2022-05-01
• Primary Completion: 2023-07-07
• Study Completion: 2023-07-07
• Status Verified: 2023-08
• Last Update Submitted: 2023-08-13
• Last Update Posted: 2023-08-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 208

Inclusion Criteria

1. Male and females aged 18-65 years old, inclusive.
2. Females must be non-pregnant, non-lactating.
3. Proficient in English and have internet access and a mobile phone.
4. Insomnia symptoms as classified by an Insomnia Severity Index (ISI) score of 8 - 21 and have experienced these symptoms over the past month at pre-screening.
5. Stated willingness to comply with all study procedures and availability for the duration of the study.
6. Provision of signed and dated informed consent form.
7. All male and females of childbearing potential must agree to use two forms of effective contraception from the time of signing informed consent until 30 days after study completion.

Exclusion Criteria

1. Serious medical and/or psychiatric illnesses/disorders that will require treatment during the trial period.

2. The use of any drug known to affect sleep during the study one week prior the randomization, including:

   1. Sedatives (benzodiazepines, Z drugs, agomelatine, suvorexant, sodium oxybate, sedating antidepressants, sedating antihistamines, antipsychotics, melatonin, valerian).
   2. Opioids (e.g. morphine, codeine, oxycodone, methadone, buprenorphine, fentanyl, tramadol, tapentadol, hydromorphone).
   3. Stimulants (e.g. methylphenidate, dexamphetamine, modafinil, phentermine).

3. Excessive caffeine use (defined as > 600mg caffeine or approximately 6 cups of caffeinated beverages a day) that, in the opinion of the medical doctor, contributes to the participant's insomnia.

4. Excessive alcohol use (defined as per NHMRC guideline, i.e. no more than four standard drinks per day on average for men, and for women, no more than two).

5. The use of cannabinoids or a cannabinoid-based medicine within 3 months prior to study Day 1 and unwillingness to abstain from recreational drug use during the study period.

6. Cannabis dependence or any other drug or alcohol dependence within the past two years.

7. Positive urine drug screen (e.g., amphetamines type substances, benzodiazepines, cannabinoids, cocaine, and opiates) at screening or Day -1 or a history of drug abuse within the past 2 years.

8. Known hypersensitivity to cannabis-based products or any of the excipients in the study drug.

9. Use of any investigational drug or involvement in another clinical trial within 30 days of screening day.

10. Use of anti-coagulant drugs such as warfarin or those known to be metabolised by CYP450 enzymes.

11. Current or ongoing treatments for insomnia (e.g. cognitive-behavioural therapy (CBT) and CNS-active drugs).

12. Obstructive sleep apnoea determined by the MAPI questionnaire or other self-reported sleep disorders.

13. Medical conditions that result in frequent sleep disturbance (e.g. nocturia).

14. History of attempted suicide in the past 12 months.

15. Clinically significant hepatic abnormalities determined by the screening blood test.

16. Shift work, jet lag or trans-meridian travel (two time zones) in the past month.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
50 mg CBD	50 mg Cannabidiol (CBD)	50 mg CBD to be administered as a single oral dose. Each capsule contains 25 mg CBD. Two capsules to be taken (plus two placebo capsules)
50 mg CBD	Placebo	50 mg CBD to be administered as a single oral dose. Each capsule contains 25 mg CBD. Two capsules to be taken (plus two placebo capsules)
50 mg CBD	100 mg Cannabidiol (CBD)	50 mg CBD to be administered as a single oral dose. Each capsule contains 25 mg CBD. Two capsules to be taken (plus two placebo capsules)
100 mg CBD	50 mg Cannabidiol (CBD)	100 mg CBD to be administered as a single oral dose. Each capsule contains 25 mg CBD. Four capsules to be taken.
100 mg CBD	100 mg Cannabidiol (CBD)	100 mg CBD to be administered as a single oral dose. Each capsule contains 25 mg CBD. Four capsules to be taken.
Placebo	Placebo	Placebo capsules contain no CBD. Four capsules to be taken as a single oral dose.

Primary Outcome Measures

Name	Time	Method
To investigate the effect of the administration of a 50mg and 100mg per day oral CBD product versus placebo over 8 weeks on insomnia severity index scores	Baseline (week 0), week 4, week 8	Insomnia Severity Index (ISI): A 7-item tool measuring the nature, severity, and impact of insomnia over the past 2 weeks. Each item uses a 5-point Likert scale to capture a rating (0 = no problem; 4 = very severe problem) which add up to: no insomnia (0 - 7); sub-threshold insomnia (8 - 14); moderate insomnia (15 - 21); and severe insomnia (22 - 28).

Secondary Outcome Measures

Name	Time	Method
To determine the effect of 8 weeks of 50mg or 100mg of CBD compared to placebo on wake after sleep onset (WASO) as assessed by actigraphy.	Baseline (week 0), week 8	WASO is a parameter that examines the total amount of minutes awake after the first sleep epoch is achieved. Therefore, as the WASO increases, sleep efficiency decreases.
To determine the effect of 8 weeks of 50mg or 100mg of CBD compared to placebo on Anxiety as assessed by the DASS-21 questionnaire.	Baseline (week 0), Week 4, week 8	Depression Anxiety Stress Scale-21 (DASS-21): A 21-item tool with subscales measuring the negative emotional states of depression, anxiety, and stress separately. Depression ranges from normal (0-9) to extremely severe (28+); anxiety ranges from normal (0-7) to extremely severe (20+); and stress ranges from normal (0-14) to extremely severe (34+).
To determine the effect of 8 weeks of 50mg or 100mg of CBD compared to placebo on Stress as assessed by the DASS-21 questionnaire.	Baseline (week 0), Week 4, week 8	Depression Anxiety Stress Scale-21 (DASS-21): A 21-item tool with subscales measuring the negative emotional states of depression, anxiety, and stress separately. Depression ranges from normal (0-9) to extremely severe (28+); anxiety ranges from normal (0-7) to extremely severe (20+); and stress ranges from normal (0-14) to extremely severe (34+).

Trial Locations

Locations (2)

Woolcock Institute; 🇦🇺 Glebe, New South Wales, Australia

Fusion Clinical Research; 🇦🇺 Adelaide, South Australia, Australia