The Efficacy and Safety of CBD-dominant Cannabis Oil on Chronic Insomnia

Phase 2

Completed

• Conditions: Chronic insomnia; Cannabidiol; CBD-dominant Cannabis oil

• Registration Number: TCTR20230417005
• Lead Sponsor: Health System Research Institute

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Completion: 2023-03-01
• Study Start: 2023-04-17
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 37

Inclusion Criteria

1. Diagnosis of primary insomnia according to the DSM -5 by a physician
2. Insomnia Severity Index (ISI) score greater than 30 (moderate-to-severe clinical insomnia)
3. Insomnia more than 3 times a week and for more than 3 months

Exclusion Criteria

1. Shift Worker
2. Have a medical condition (such as chronic pain) or medication that causes insomnia
3. Sleep apnea (defined as Apnea Hypopnoea Index (AHI) > 30 and Oxygen Insufficiency Index (ODI) > 10) or sleep-related movement disorder, depending on the outcome of polysomnography
4. Advanced or delayed sleep-wake phase disorder, depending on Actigraphy results.
Had received any treatment for insomnia, including cognitive behavioral therapy (CBT) and CBT drugs within 3 months prior to screening or at the discretion of the physician.
5. Cross-country travel (2 time zones) within the past 1 month
6. Regular medication users including warfarin, clobazam, rifampicin, and carbamazepine.
7. Disorders of the heart and blood vessels that (Screened with a prescribed 12-lead ECG)
8. Pregnant or breastfeeding women
9. Have a history of psychiatric disorder in the past 12 months (except for mild symptoms of depression or anxiety) according to the Diagnostic Manual of Mental 10. 10. Disorders (DSM-5) or at the discretion of the physician.
11. History of suicide attempts or suicidal thoughts History of drug or alcohol abuse/dependence in the last 2 years
12. Have had an allergic reaction to marijuana and marijuana extracts
13. Have used marijuana within the past 3 months
14. Excessive daily caffeine use in the physician's opinion or inability to refrain from caffeine use for more than 24 hours prior to the overnight study visit.
15. Failed to abstain from alcohol greater than or equal to 24 hours prior to every overnight study visit.
16. A medical condition that results in frequent needing to get out of bed (e.g., frequent urination during the night)
17. A state that requires a marijuana inspection (e.g. a workplace inspection, or a court order)

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Polysomnography 3 times in total: 1) Before study drug 2) After CBD 3) After Placebo Total sleep time (TST), Sleep efficiency (SE), Wake after sleep onset (WASO), Sleep-onset latency (SOL), Arousal Index, Number of awakening (NAW), %N1, %N2, %N3, %Rapid Eye Movement (REM) stage,Actigraphy 3 Periods in total: 1) Before study drug 2) After CBD 3) After Placebo Total sleep time (TST), Sleep efficiency (SE), Sleep onset latency (SOL), Sleep fragmentation index (SFI), Number of Awakening (NAW), Light sleep (N1+N2), Deep sleep (N3), REM sleep, Sleep Score,Drug Effects Questionaire (Side-effect) 3 times in total: 1) Before study drug 2) After CBD 3) After Placebo 4) After CBD (1st Month) 5) After CBD (2nd Month) 6) After CBD (3rd Month) Side-effect

Secondary Outcome Measures

Name	Time	Method
Subjective measurements 3 times in total: 1) Before study drug 2) After CBD 3) After Placebo 4) After CBD (1st Month) 5) After CBD (2nd Month) 6) After CBD (3rd Month) Epworth sleepiness Scale (ESS) , Pittsburgh sleep quality index, Quality of life (EQ 5D 5L)