Chronic insomnia Cannabidiol CBD-dominant Cannabis oil Chronic insomnia
Conditions
Interventions
The participants received 10 mg of CBD-optimized cannabis extract (sublingual) in the morning and 1 mg/kg/dose before bed for 4 weeks,The participants received Placebo for 4 weeks
Experimental Device,Placebo Comparator Drug
Cannabidiol (CBD) oil (CNR-SL-01) ,Placebo
Sponsors
Health System Research Institute
Provincial health office (Nakhon Ratchasima)
Eligibility
Sex/Gender
All
Age
18 Years to 60 Years
Inclusion criteria
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
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)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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) | — |
Countries
Thailand
Contacts
Public ContactChakrabongse Chakrabongse
Suranaree University of Technology Hospital
Outcome results
None listed