Cannabidiol (CBD) treatment for insomnia

Phase 1

Completed

• Conditions: insomnia; Neurological - Other neurological disorders

• Registration Number: ACTRN12620000070932
• Lead Sponsor: Swinburne University of Technology

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-01-29
• Study Completion: 2022-09-30
• Last Update Posted: 13 February 2023

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

1.Males and Females Aged 18-45 years
2.Insomnia Severity Index (ISI) score of 15 or more.
3.Self-report difficulties falling and / or staying asleep (yes)
4.Dissatisfaction with current sleep patterns (yes)
5.Sleep problems interfering with daily life (yes)

Exclusion Criteria

1. Inability to speak or read English
2. Current shift worker
3. History of severe neurological, cardiac, endocrine, gastrointestinal, or bleeding disorders (self-report)
4. History of major psychiatric disorder in the past 12 months except clinically-managed mild depression
5. Severe current depression (BDI score of greater than or equal to 20)
6. Severe current anxiety (BAI score greater than or equal to 16)
7. 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.
8. Use of any CNS-active drugs (including antidepressants, opioids, benzodiazepines) for the past 3 months or at the medical officer’s discretion
9. Excessive caffeine use that in the opinion of the investigator contributes to the participant's insomnia
10. Other pre-existing sleep disorder (restless legs syndrome, narcolepsy, parasomnias etc.) (self-report)
11. Used any modality of treatment for insomnia, including CBT, within 3 months before screening or at the medical doctor's discretion
12. History of drug or alcohol dependency or abuse within approximately the past 2 years (self-report and at medical officer’s discretion)
13. Probable moderate to severe obstructive sleep apnoea (STOP-BANG questionnaire)
14. Currently participating in any other trials involving investigational or marketed products within 30 days prior to the screening visit.
15. Not willing to abstain from driving, riding, operating heavy machinery for 8 hours after taking the nightly treatment.

Study & Design

• Study Type: Interventional
• Study Design: Not specified