None listed
Conditions
Brief summary
Insomnia is a highly prevalent and burdensome disease. It is thought to affect as many as one in three adults worldwide at any one time. Treatment options for insomnia are often limited to doctor-implemented cognitive behavioural training (CBT), pharmaceutical intervention, or a combination of the two. Whilst traditionally effective, both options have considerable limitations, most frequently those associated with cost, compliance and effectiveness (CBT), or tolerance and addiction potential (pharmaceutical). The Australian Federal Government recently approved the medical use of cannabinoids among select patient groups. The main active ingredient, cannabidiol (CBD), may have sedating and/or sleep-enhancing effects. There is therefore increasing global interest as its potential use as an alternate sleep-aid. The primary objective of this research is to examine whether 2 weeks of nightly supplementation with a novel sublingual CBD-treatment improves sleep outcomes among individuals with moderate-severe insomnia. Specifically, we seek to examine the effect of treatment on subjective [sleep onset latency, sleep efficiency (%), and time awake after sleep onset] and objective sleep quality [as measured by Actigraphy outcomes (time in bed, sleep efficiency (%), number of awakenings, sleep latency) after 2-week supplementation with sublingual CBD compared with a placebo.
Interventions
This three-week, between-subjects, randomised, placebo-controlled pilot trial will be used to determine effects of a single dose of an oral cannabinoid medicine, to be self-administered at least one hour before bedtime, on sleep and next-day function relative to placebo in individuals with self-reported moderate-severe insomnia [determined using a cut-off of at least 15 on the Insomnia Severity Index (ISI)] and self-reported sleep problems [self-report difficulties falling and/or staying asleep,
This three-week, between-subjects, randomised, placebo-controlled pilot trial will be used to determine effects of a single dose of an oral cannabinoid medicine, to be self-administered at least one hour before bedtime, on sleep and next-day function relative to placebo in individuals with self-reported moderate-severe insomnia [determined using a cut-off of at least 15 on the Insomnia Severity Index (ISI)] and self-reported sleep problems [self-report difficulties falling and/or staying asleep, dissatisfaction with current sleep patterns and sleep problems interfering with daily life (all yes). The investigational product is an oral solution containing cannabinoids and corn oil at a concentration of 100mg CBD/mL. The total active treatment to be provided per day is 200mg CBD in 2mL treatment. The treatment will be self-administered one hour before bedtime. They will be randomised to receive either the intervention (a single fixed dose of CBD product) or matched placebo - both 2mL/day, for three weeks (three weeks dosing period in total). The study investigator will instruct and coach the participant to self-administer the dose of the oral solution via a plastic syringe, to be consumed at home each night before bed (2ml/day), using a 2mL syringe provided by the study medical doctor.
Sponsors
Swinburne University of Technology
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to 45 Years
Healthy volunteers
No
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.
Outcome results
None listed