None listed
Conditions
Brief summary
The purpose of this trial is to assess the efficacy of cannabidiol (98% CBD) for sleep disturbances in healthy adults. This study will compare the botanical CBD with a placebo and evaluate its efficacy via the PROMIS sleep disturbance instrument. The study will take place in 4 sites; Brisbane, Sydney, Lismore and Melbourne. In total, the study will successfully enrol 438 participants. Eligible participants will be between 18 to 65 years old, considered to be generally healthy and self-reports sleep difficulty and quality. The trial will be 10 weeks, with an initial two-week titration period and a phone call one month after stopping medication. The study will involve a 15mg CBD per soft gelatin capsule or placebo capsule that is similar in appearance, smell and taste. The active product will contain hemp seed oil as the carrier and 0.5 mL of liquid encapsulted into a gelatin/ glycerin soft capsule. CBD will make up >98% of the total cannabinoids in the capsule. Participants will take 1 capsule after breakfast and 1 capsule 30 minutes before bed and build up to a tolerance/ maximum dose during the titration period with the maximum morning dose being 2 capsules and the maximum night dose being 8 capsules. After the titration period, the participants will stay on their maximum dose for 8 weeks or until they withdraw from the study. In total, the study should be 10 weeks in total with a one month follow up phone call after the ceasing the medication. The expected outcome is that a botanical CBD (98%) will significantly improve people's sleep who suffer from sleep disturbance more than the placebo.
Interventions
The study will involve a 15mg CBD per soft gelatin capsule. The active product will contain hemp seed oil as the carrier and 0.5 mL of liquid encapsulated into a gelatin/ glycerin soft capsule. CBD will make up >98% of the total cannabinoids in the capsule. Non-active ingredients include hemp seed oil, glycerin and gelatin. The product will be packaged into white, opaque HDPE pill packer bottles with a 0.5 g desiccant and a white, heat-induction cap and perforated neckband. The product will be l
The study will involve a 15mg CBD per soft gelatin capsule. The active product will contain hemp seed oil as the carrier and 0.5 mL of liquid encapsulated into a gelatin/ glycerin soft capsule. CBD will make up >98% of the total cannabinoids in the capsule. Non-active ingredients include hemp seed oil, glycerin and gelatin. The product will be packaged into white, opaque HDPE pill packer bottles with a 0.5 g desiccant and a white, heat-induction cap and perforated neckband. The product will be labelled with the identity of the group. Full list of ingredients used: Cold-Press Hemp Seed Oil and Hemp THC-Free Broad-spectrum extract, Glycerin and Gelatin. Initially, participants will undergo a titration period of two weeks. During this time, they will be taking 1 capsule after breakfast and 1 capsule 30 minutes before bed. The second day, the participant will take 2 capsules after breakfast and before bed. If 2 capsules made the person drowsy through the day, it will be reduced to 1 capsule. The night dose will continue to increase by 1 capsule each night until the participant feels that is best dose to help their sleep or they reach maximum dose. Maximum dose during the titration period will be maximum morning dose being 2 capsules and the maximum night dose being 8-9 capsules (10 capsules per day). After the titration period, the participants will stay on their maximum dose for 8 weeks or until they withdraw from the study. In total, the study should be 10 weeks in total with a one month follow up phone call after ceasing the medication. Compliance will be measured by capsule return and counting at each follow-up. The participants will be asked to bring back all empty containers as well as those with capsules remaining. These will also be checked against the participant diaries.
Sponsors
Southern Cross University
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 65 Years
Healthy volunteers
No
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,
Outcome results
None listed