A Phase III Double-Blind, Randomised Placebo-Controlled Clinical Trial to evaluate the efficacy and safety of a botanical cannabidiol (CBD) for sleep disturbances in a healthy population.

INTERVENTION: 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 CONDITION: Alternative and Complementary Medicine ‐ Herbal remedies Mental Health ‐ Anxiety Mental Health ‐ Other mental health disorders Neurological ‐ Other neurological disorders Sleep Disturbances;Anxiety;chronic pain;Fatigue; ; Sleep Disturbances ; Anxiety ; chronic pain ; Fatigue PRIMARY OUTCOME: To evaluate the efficacy of a botanical CBD for sleep disturbances compared to a placebo via the PROMIS sleep disturbance instrument. [At the enrolment/ baseline visit (week ‐2) and week 4 and week 8 (primary endpoint) post‐randomisation. ] 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. SECONDARY OUTCOME: Assessing the number and severity of adverse events via CTCAE.[At the enrolment/baseline visit (week ‐2) and week 4 and week 8 (end point) post‐randomisation.] To assess kidney function via blood pathology.[At the enrolment/baseline visit (week ‐2) and week 4 and week 8 (end point) post‐randomisation. ] To assess liver enzymes for safety via pathology testing.[At the enrolment/ baseline (week ‐2) and week 4 and week 8 (end point) post‐randomisation. ] To assess quality of life of CBD comparing botanical CBD versus placebo via the Brief Fatigue inventory[Once a week for 8 weeks post‐randomisation visit. Each time point will be evaluated using a longitudal analysis.] To assess safety of CBD via side effect profile via direct observation on follow up phone calls and face to face visits and participant reported on participant diaries.[At the enrolment/baseline visit (week ‐2) and week 4 and week 8 (end point) post‐randomisation. ] To assess the quality of life of CBD comparing botanical CBD versus placebo via the SF‐20.[At the enrolment/ baseline visit (week ‐2) and week 4 and week 8 post‐randomisation. ] To evaluate the efficacy of CBD for anxiety comparing botanical CBD versus placebo via the Hamilton Anxiety Rating Scale. [At the enrolment/ baseline (week ‐2) and week 4 and week 8 post‐randomisation. ] To evaluate the efficacy of CBD for chronic pain (as defined as greater than 3 months of chronic pain) comparing botanical CBD versus placebo via the pain disability index (PDI).[At the enrolment/ baseline (week ‐2) and week 4 and week 8 post‐randomisation. ]