A Phase III Double-Blind, Randomised Placebo-Controlled Clinical Trial to evaluate the efficacy and safety of a botanical cannabidiol (CBD) for sleep disturbances in a healthy population.

Phase 3

Completed

• Conditions: Sleep Disturbances; Anxiety; chronic pain; Fatigue; Alternative and Complementary Medicine - Herbal remedies; Mental Health - Anxiety; Mental Health - Other mental health disorders; Neurological - Other neurological disorders

• Registration Number: ACTRN12621000632897
• Lead Sponsor: Southern Cross University

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-05-27
• Study Completion: 2022-11-16
• Last Update Posted: 6 March 2023

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 328

Inclusion Criteria

1. Adults aged between 18 and 65 years old.
2. Considered to be generally healthy.
3. A self-reported complaint of poor sleep quality that includes one or more of the following:
-Difficulty initiating sleep
-Difficulty maintaining sleep
-Waking up earlier than desired
4. Self-reports sleep difficulty occurring three nights a week or more for three months.

Exclusion Criteria

1. Pregnant or breast-feeding women
2. Anyone with an acute disease
3. Severe sleep disturbances
4. Current sleep apnoea (historical diagnosis of sleep apnoea which has since resolved is acceptable)
5. Diagnosed sleep disturbances (e.g. narcolepsy, parasomnias, insomnias)
6. Severe anxiety
7. Current, clinically significant anxiety disorder
8. History of an unmanaged and/or poorly managed chronic disease
9. Severe mental illness, suicidal ideation and/or difficulty communicating (mild to moderate, well-managed depression is acceptable)
10. Current antipsychotic use
11. Recreational drug use (positive DOA urine test). If screening DOA test is positive to THC ONLY, participants will have the opportunity for 1 x re-test 2 weeks after the positive result.
12. Alcohol intake higher than 14 units per week
13. Smokes more than 2 nicotine cigarettes daily
14. Works regular shift work
15. Travels across more than 2 time zones in the last two weeks.
16. Consumes more than 300mg/day of caffeine. (The average cup of coffee is equivalent to 95-100mg of caffeine so 300mg is equivalent to 3 cups of coffee, 4 cups of regular tea and 6 of 350ml of cola. It is advised that no caffeine be consumed after 3pm in the afternoon.)
17. People with liver enzymes greater than 1.5 x ULN (a single re-test of screening pathology is permitted)
18. People who have ever had a cardiac arrest or have current clinically significant cardiovascular disease
19. eGFR < 60
20. Any elevation in creatinine on screening pathology above the ULN
21. Current oral steroid administration (concurrent use of topical and/or inhaled steroids are acceptable)
22. Current chemotherapy, radiation, immune suppressant therapy, immunotherapy or similar medical treatments.
23. Current warfarin administration
24. Current amphetamine administration (prescription or illicit) (e.g. Ritalin, Adderall, Concerta)
25. Presence of implanted electronic medical device (e.g. pacemaker, defibrillator)
26. Vaccination of any kind in the 14 days prior to commencing IMP administration,

Study & Design

• Study Type: Interventional
• Study Design: Not specified